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Major Safety Alerts in July 2009 (This page is subject to further review)
The following safety alerts has a reasonable chance that the product will cause serious health problems or death. These cases will be forming part of the summary of July 2009 and more details will be provided when available Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada Source of Date of Issue Agent Contact MDCO Ref. No. Description of Product Reference No. by Source Alert Type by Source Local Agent Information (YYYY/MM/DD) Telephone No. Bausch & Lomb Boston Conditioning Solution Original Formula Medtronic SynchroMed II (Model 8637) Implantable Drug Infusion Pump Battery Performance Boston Scientific Flexima Biliary Catheter System Respironics BiPAP Focus Noninvasive Ventilator System BD 60ml Lurt-Lok Syringes (Recorder Number 309653; Lot No.: 819101A) Boston Scientific Flexima and Percuflex drainage catheter family (pigtail style, peripheral interventions), Percuflex and percutaneous model drainage catheter family (urology) Medtronic Model 8551 sYNCHROmED Refill Kits w/ reversed UBD and Mfg Dates Medtronic QUICK-SET INFUSION SETS Models MMT-396, MMT-397, MMT-398 and MMT-399 Boston Scientific LeVeen Needle Electrodes 5.0cm Welch Allyn AED 10 and MRL JumpStart Defibrillators Bausch & Lomb (Hong Kong ) Ltd Medtronic International Ltd. Boston Scientific Hong Kong Ltd FDA BD N.A. Firm Initiated Field Action 2009/07/02 Bausch & Lomb (Hong 2213 3371 Kong ) Ltd Medtronic International 2919 1362 Ltd. Boston Scientific Hong 2960 7136 Kong Ltd Celki Medical Company 2268 9258 BD 2575 8668
N.A.
Firm Initiated Field Action
2009/07/06
N.A. Z-1606-2009 N.A.
Firm Initiated Field Action Class I Firm Initiated Field Action
2009/07/08 2009/07/09 2009/07/09
MHRA
N.A.
MDA
2009/07/10
Boston Scientific Hong 2960 7136 Kong Ltd Medtronic International 2919 1362 Ltd. Medtronic International 2919 1362 Ltd. Boston Scientific Hong 2960 7136 Kong Ltd Welch Allyn N,A,
Medtronic International Ltd. Medtronic International Ltd. Boston Scientific Hong Kong Ltd Welch Allyn
MDA/2009/043
Firm Initiated Field Action
2009/07/10
N.A. N.A.
Firm Initiated Field Action Firm Initiated Field Action
2009/07/10 2009/07/10
N.A.
Firm Initiated Field Action
2009/07/21
Monthly Summary of Medical Device Safety Alerts - June 2009
Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada Date of Issue MDCO Ref. Source of Local Agent Description of Product Reference No. by Source Alert Type by Source (YYYY/MM/DD) No. Information SN090601 SN090602 SN090603 SN090604 SN090605 SN090606 SN090607 SN090608 SN090609 SN090610 SN090611 SN090612 SN090613 SN090614 SN090615 SN090616 SN090617 SN090618 SN090619 SN090620 SN090621 SN090622 SN090623 SN090624 SN090625 Hologic Discovery and Explorer X-ray Bone Densitometer Systems CME McKinley T34 Syringe Driver GE Signa Ovation systems with CTL Array, XL Body Flex and Open Body Coils ThermoFisher Scientific Salmonella Chromogenic medium PO0958A DePuy PFC Sigma Cruciate Retaining Non-Porous Size 5 Left Femoral Component KeyMed, Olympus, Aloka WM-NP1 (Workstation) Stryker Triathlon TS Knee System Offset Adapter Trial Teleflex Medical (Athlone) Arrow 12 French Triple-Lumen 20cm & 16cm Large-Bore Central Venous Catheters Moria Evolution 3E Welch Allyn Vital Signs Monitor VSM 300 Aerocrine NIOX and NIOX Flex, 03-1000 resp 03-1000-F Siemens Medical Acuson X300 System with Swiftlink Connector DL260 Medical Devices Group Computer treatment planning Smith & Nephew Legion Pressfit Stems 71424053 & 71424043 Stryker Mantis Rod Inserter Shaft ThermoFisher PB0378A ThermoFisher PO1110A Roche Diagnostics Elecsys Folate III Merit Medical Systems Prelude Short Sheath Introducer CalMed Op-Flex Poole (Handle Set) contained within Procedure Packs Siemens Medical ACUSON Sequoia, auxiliary CW transducer Medmont E300 Corneal Topographer, DV2000 Digital Imaging Software and M700 Automated Perimeter Ethicon (JNJ) Endopath Endoscopic Linear Cutters (Model # LONG45A; ATB45, ATW45; NAW45) CMS Focal Software CD Immucor Gallileo Echo Blood Analyzer (Model 87000) MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA Health Canada Health Canada Health Canada Health Canada 2009/004/029/061/013 2009/004/028/291/009 2009/003/012/061/013 2009/005/008/601/004 2009/005/014/081/001 2009/005/007/061/003 2009/005/013/081/011 2009/005/014/081/003 2009/003/023/401/006 2008/012/005/601/002 2009/005/014/051/012 2009/005/014/081/012 2009/005/017/601/002 2009/004/016/051/009 2009/005/006/061/001 2009/005/006/601/001 2009/005/006/601/002 2009/004/029/061/008 2009/004/024/051/002 2009/005/014/291/013 2009/005/014/081/013 45746 47966 48015 47888 FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA Type II Type II Type II Type II 2009/06/01 2009/06/01 2009/06/01 2009/06/01 2009/06/01 2009/06/01 2009/06/01 2009/06/01 2009/06/01 2009/06/01 2009/06/01 2009/06/01 2009/06/01 2009/06/01 2009/06/01 2009/06/01 2009/06/01 2009/06/01 2009/06/01 2009/06/01 2009/06/01 2009/06/02 2009/06/02 2009/06/02 2009/06/02 N.A. N.A. GE Medical Systems Hong Kong Ltd. N.A. N.A. N.A. Stryker China Ltd N.A. N.A. N.A. N.A. Siemens Healthcare Diagnostic Limited N.A. N.A. N.A. N.A. N.A. Roche Diagnostics (Hong Kong) Ltd King Health Limited N.A. Siemens Healthcare Diagnostic Limited Park World Development Ltd N.A. N.A. Uninet Technology LTD Agent Contact Telephone No N.A. N.A. 2783 1838 N.A. N.A. N.A. 2518 6915 N.A. N.A. N.A. N.A. 2810 7533 N.A. N.A. N.A. N.A. N.A. 2485 7510 2481 3787 N.A. 2810 7533 2880 9689 N.A. N.A. 2838 8423
Medical Device Control Office
2
Department of Health The Government of HKSAR
SN090626 SN090627 SN090628 SN090629 SN090630 SN090631 SN090632 SN090633 SN090634 SN090635 SN090636 SN090637 SN090638 SN090639 SN090640 SN090641 SN090642 SN090643 SN090644 SN090645 SN090646 SN090647 SN090648 SN090649 SN090650 SN090651
FisherDiagnostics Infinity Glucose Hexokinase Reagent (Catalog # TR15498) Premier Dental Integra CEM (Model# 3001410) Leckey Four-point Pelvic Harness (Model no 122-719) Sunrise Mobility Quickie LXI Manual Wheelchair (Model# LXI034741, LXI-034609, LXI-034740, LXI-034500) Beckman Coulter Synchron Systems Ammonia (AMM) Reagent (Model#439770) Sonomed Vumax Ophthalmic Ultrasound Scanner (Model#SHFS35S) Boston Scientific Contak Renewal 4 CRT-D and Vitality 2 Acid MEDEX SBI Injector Promotal SAS Quest and Duolys exam couches and Ambéo, 3181 and 3185 chairs GE Healthcare Definium 5000 digital X-ray systems Siemens Medical Symbia S and Symbia T Marflow AG - Medical Equipment Grabit 3 prong grasping forcep Corin Uniglide Unicondylar Knee - femoral component Varian Clinacs with C Series version 7.x and the SRS Motion Disable Option Depuy (JNJ) Knee Replacement Implant Arjo Maxilift Beckman Coulter AutoMate Sample Processing Systems BD Syringe 10ml Luer-Lok GE Healthcare ApexPro Telemetry System Alcon 25 GA Total Plus Pak and Vitrectomy 25 GA Custom Pak Kimberly-Clark Synthetic Powder Free Vinyl Exam Gloves (Size: S, M and L) (Cat. No. 55031, 55032, 55033) Abbott ARCHITECT Reaction Vessel (List no 7C15-01) Abbott Cell-Dyn Ruby Hematology Analyzer with System Softare Version 2.0ML (List no. 08H67-01) Siemens Medical Immulite 2000 and Immulite 2500 digital Fluidics PC Board (Part no. 450116-0002) MEDRAD Sterile Disposable Syringe Kit (Catalog. no DSK 130-Q) Synthes Spine Square Nut MR Safe (Catalog no. 03.311.060)
Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada MHRA MHRA MHRA MHRA MHRA MHRA Varian Medical Systems Pacific Inc. MHRA MHRA MHRA BD FDA FDA FDA FDA FDA FDA FDA FDA
47989 48059 47922 47380 47835 47987 47031 2009/003/010/601/001 2009/005/011/291/012 2009/005/007/051/002 2009/003/016/291/004 2009/002/027/401/005 2009/004/023/061/002 N.A. MDA/2009/037 2009/004/016/261/001 2009/005/014/601/001 N.A. Z-1227-2009 Z-1412-2009 to Z-1413-2009 Z-1414-2009 Z-1398-2009 Z-1398-2009 Z-1399-2009 Z-1228-2009 Z-1324-2009
Type II Type II Type II Type II Type II Type II Type II FSCA FSCA FSCA FSCA FSCA FSCA Firm Initiated Field Action MDA FSCA FSCA Firm Initiated Field Action Class II Class II Class II Class II Class II Class II Class II Class II
2009/06/02 2009/06/02 2009/06/02 2009/06/02 2009/06/02 2009/06/02 2009/06/02 2009/06/03 2009/06/03 2009/06/03 2009/06/03 2009/06/03 2009/06/03 2009/06/03 2009/06/04 2009/06/05 2009/06/05 2009/06/05 2009/06/08 2009/06/08 2009/06/08 2009/06/08 2009/06/08 2009/06/08 2009/06/08 2009/06/08
N.A. N.A. Otto Bock Asia Pacific Limited N.A. Beckman Coulter Hong Kong Ltd N.A. Boston Scientific Hong Kong Ltd N.A. N.A. N.A. Siemens Healthcare Diagnostic Limited N.A. N.A. Varian Medical Systems Pacific Inc. Johnson & Johnson Medical (HK) ArjoHuntleigh (Hong Kong) Ltd Beckman Coulter Hong Kong Ltd BD GE Medical Systems Hong Kong Ltd. Alcon Hong Kong Ltd Kimberly-Clark (Hong Kong) Limited Abbott Laboratories LTD. Abbott Laboratories LTD. Siemens Healthcare Diagnostic Limited Medrad Asia Pte.Ltd Synthes (Hong Kong) Ltd
N.A. N.A. 2598 9772 N.A. 2240 6150 N.A. 2960 7136 N.A. N.A. N.A. 2810 7533 N.A. N.A. 2724 2836 2738 6027 2508 9553 2240 6150 2575 8668 2783 1838 2568 0636 2334 3361 2593 2211 2593 2211 2810 7533 65-6752 5318 2724 2032
Medical Device Control Office
3
Department of Health The Government of HKSAR
SN090652 SN090653 SN090654 SN090655 SN090656 SN090657 SN090658 SN090659 SN090660 SN090661 SN090662 SN090663 SN090664 SN090665 SN090666 SN090667 SN090668 SN090669 SN090670 SN090671 SN090672 SN090673 SN090674 SN090675 SN090676 SN090677
Synthes Spine InSitu Bender Cutter Kit Wide Sterile (Cat. No. 530.521S) and InSitu Bender Cutter Kit Narrow Sterile (Cat. No. 530.522S) Argon Medical Devices ArgoGuide Hydrophilic NiTi Guidewire Zimmer TM-400 Broach Handle AGA Medical Amplatzer Cardiac Plug Zimmer TransFx External Fixation System drill bit, quick connect Ortho-Clinical Diagnostics Veridex LLC CellTracks AutoPrep System Biomet Microfixation Arthrosimplicity and OnPoint Scope kits, Becton Dickinson syringe component Siemens Medical Immulite 2000 / Immulite 2500 Chemiluminescent Substrate Module Trinity Biotech TriniCAL Reference Plasma and TriniCHECK Control Levels 1, 2 & 3 Beckman Coulter UniCel DxC 880i, 860i, 680i & 660i Synchron Access Clinical Systems Invacare Harrier Plus, HD & XHD Philips Synergy Flex-M / Shoulder Coil Mölnlycke Phaco Pack Shepton Mallet JAV 17177 Gambro AK200 S equipped with UFD and AK 200 ULTRA S in combination with BiCart Select Allergan Medical FloWatch-PAB GE Healthcare Innova 2100IQ, 3100, 3100IQ, 4100, 4100IQ, 2121IQ & 3131IQ Tosoh Bioscience Hemoglobin F&A2 control set Trinity Biotech TriniCLOT aPPT HS EBI Titanium Cannulated Screws and Bone Screws Philips MD Allura FD Varian Eclipse Treatment planning System, version 8.6 and earlier (Product Code: H48) Stryker Gamma3 Plus Obese Targeting System, Gamma3S Trochanteric Nail 170 and Gamma 3 Stryker Surgical Table Headrest (Catalog/Part # 0788-300-012) Terumo Advanced Perfusion System 1 Central Control Monitor (Catalog no 802100) Biomet Dual Offset Broach Handle, Clamping Style, Left (REF 31555403) and Right (REF 31-555404) Spectranetics SLS II Lasr Sheath Kit, 14F (REF 500-012)
FDA FDA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA Gambro Hong Kong Ltd MHRA MHRA MHRA MHRA MHRA MHRA Varian Medical Systems Pacific Inc. FDA FDA FDA FDA FDA
Z-1248-2009 to Z-1249-2009 Z-1267-2009 to Z-1307-2009 2009/005/011/291/010 2009/002/018/291/006 2009/005/007/061/017 2009/005/012/081/014 2009/004/002/601/001 2009/005/027/081/003 2009/005/027/291/008 2009/005/021/601/001 2007/005/024/061/002 2009/005/028/051/005 2009/005/029/081/003 N.A. 2009/005/028/051/010 2009/006/002/081/006 2009/005/014/051/010 2009/005/022/081/001 2009/004/024/601/004 2009/006/003/291/017 N.A. Z-1349-2009 to Z-1351-2009 Z-1418-2009 Z-1224-2009 Z-1352-2009 to Z-1353-2009 Z-1264-2009
Class II Class II FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA Firm Initiated Field Action FSCA FSCA FSCA FSCA FSCA FSCA Firm Initiated Field Action Class II Class II Class II Class II Class II
2009/06/08 2009/06/08 2009/06/08 2009/06/08 2009/06/08 2009/06/08 2009/06/08 2009/06/08 2009/06/08 2009/06/09 2009/06/09 2009/06/09 2009/06/09 2009/06/10 2009/06/11 2009/06/11 2009/06/11 2009/06/11 2009/06/11 2009/06/12 2009/06/12 2009/06/15 2009/06/15 2009/06/15 2009/06/15 2009/06/15
Synthes (Hong Kong) Ltd N.A. Zimmer PTE Ltd. (Hong Kong branch) N.A. Zimmer PTE Ltd. (Hong Kong branch) Ortho Clinical Diagnostics N.A. Siemens Healthcare Diagnostic Limited N.A. Beckman Coulter Hong Kong Ltd N.A. Philips Health Care (Great China) N.A. Gambro Hong Kong Ltd N.A. GE Medical Systems Hong Kong Ltd. N.A. N.A. N.A. Philips Health Care (Great China) Varian Medical Systems Pacific Inc. Stryker China Ltd Stryker China Ltd TERUMO CHINA (H.K.) LTD. N.A. N.A.
2724 2032 N.A. 2992 0968 N.A. 2992 0968 2737 5504 N.A. 2810 7533 N.A. 2240 6150 N.A. 2821 5480 N.A. 2839 9710 N.A. 2783 1838 N.A. N.A. N.A. 2821 5480 2722 8122 2518 6915 2518 6915 2866 0811 N.A. N.A.
Medical Device Control Office
4
Department of Health The Government of HKSAR
SN090678 SN090679 SN090680 SN090681 SN090682 SN090683 SN090684 SN090685 SN090686 SN090687 SN090688 SN090689 SN090690 SN090691 SN090692 SN090693 SN090694 SN090695 SN090696 SN090697 SN090698 SN090699 SN0906100
Varian CLINAC Software Versions 6.X and 7.X (Remote Auto Motions) Zimmer Nexgan LPS and Nexgen LPS-Flex Femoral Components Roche PSM with Validation Module (Model# 03009696001, 03265439001) Abbott i-STAT 1 Analyzer System-Instrument (Model/Catalog # 06F16-10) Stryker Austin Moore Stems - Curved 43mm (Model/Catalog# 69390-430) Siemens Acuson S2000 VA10 (Model / Catalog# 10041461) Cook Zenith Renu AAA Converter, Zenith Renu AAA Main Body and Zenith AAA Main Body Bifurcated Stent Medline Penrose Drain Ansell Healthcare Derma Prene Ultra Surgical Glove (Model/Catalog # 851365 / 851470) Motion Concepts Tilt/Elevating Seating System and Tilt/Elevate/Recline Seating System Walter Lorenz Surgical (Biomet Microfixation) Dean Scissors (Model: 09-0142) Viewsonic VGM 19" Monitor Roche Accu-chek Performa Abbott POWERSAIL Coronary Dilatation Catheter ThermoFisher PO0171A brilliant green agar Heliosphere Bag Intragastric Balloon GE Healthcare Ge Signa Hdx 3T MR Systems, Ge Signa Hdxt 3T MR Systems Edwards Lifesciences Introflex Tuohy-Borst Valve Introducer Ortho-Clinical Diagnostics VITROS 3600 immunodiagnostic system, VITROS 5600 integradeted system Philips CareVue Chart Release C.O. (Part Number 862246) Synthes Zero-P StarDrive Screwdriver Shaft, T8 (Catalog# 03.617.902) Innovative Neurotronics WalkAide Stimulator System Control Module (Part No. 20-0100) TEVA Medical Device TEVADAPTOR Closed Drug Reconstitution and Transfer System (Model no. MG412110)
Varian Medical Systems Pacific Inc. Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Roche Diagnostics (Hong Kong) Ltd Abbott Laboratories LTD. MHRA MHRA MHRA MHRA MHRA FDA FDA FDA FDA BD Cemma Enterprise Co., Ltd
N.A. 48206 47890 48245 48207 48077 47349 48072 48229 46283 47701 48079 N.A. N.A. 2009/006/004/601/002 MDA/2009/040 2009/006/008/291/012 2009/005/028/051/012 2009/006/002/051/003 Z-1436-2009 Z-1348-2009 Z-1435-2009 Z-1244-2009 N.A. N.A.
Firm Initiated Field Action Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Firm Initiated Field Action Firm Initiated Field Action FSCA MDA FSCA FSCA FSCA Class II Class II Class II Class II Firm Initiated Field Action Firm Initiated Field Action
2009/06/15 2009/06/15 2009/06/15 2009/06/15 2009/06/15 2009/06/15 2009/06/15 2009/06/15 2009/06/15 2009/06/15 2009/06/15 2009/06/15 2009/06/16 2009/06/16 2009/06/17 2009/06/19 2009/06/19 2009/06/19 2009/06/22 2009/06/22 2009/06/22 2009/06/22 2009/06/22 2009/06/22 2009/06/22
Varian Medical Systems Pacific Inc. Zimmer PTE Ltd. (Hong Kong branch) Roche Diagnostics (Hong Kong) Ltd Abbott Laboratories LTD. Stryker China Ltd Siemens Healthcare Diagnostic Limited N.A. N.A. N.A. N.A. N.A. ViewSonic Hong Kong Roche Diagnostics (Hong Kong) Ltd Abbott Laboratories LTD. N.A. N.A. GE Medical Systems Hong Kong Ltd. N.A. Ortho Clinical Diagnostics Philips Health Care (Great China) Synthes (Hong Kong) Ltd N.A. N.A. BD Cemma Enterprise Co., Ltd
2722 8122 2992 0968 2485 7510 2593 2211 2518 6915 2810 7533 N.A. N.A. N.A. N.A. N.A. 3690 1398 2481 3387 2593 2211 N.A. N.A. 2783 1838 N.A. N.A. 2821 5480 2724 2032 N.A. N.A. 2575 8668 2412 2310
SN0906101 BD Beaver Arthro-Lok Pointed Tip 4mm Blade (Cat no. 376780) SN0906102 Arrow International Pediatric Two-Limen Central Venous Catheterization Set with Blue FlexTip Catheter (Cat no. CS-14502)
Medical Device Control Office
5
Department of Health The Government of HKSAR
SN0906103 Select Healthcare Locomotor lifting slings for adults and children SN0906104 Philips Avalon Fetal Monitor SN0906105 Boston Scientific Resolution Clip Philips Respironics MicroElite Nebulizer Compressors (Medel SN0906106 Product No. 91709 to 91716, Respironics Product No. 1053626, 1053677 to 1053683) SN0906107 Terumo Advanced Perfusion System 1 (Catalog no 802100) Bard Vacora Vacuum Biopsy System (Model# VC10118P) and Vacora Vacuum Biopsy System-Cannula (Model# VC10118MR) GE Healthcare AW Volumeshare2 - Software Options (Model# SN0906109 B79011MA) SN0906108 SN0906110 Stryker Vertier Table Headrest Attachment (Model # 0788-300-012) SN0906111 ACIST Angiographic System - Manifold Kit (Model # BT2000) SN0906112 CMS XIO Radiation Treatment Planning System SN0906113 R&D Systems Quantikine IVD Human B2-Microglobulin (Lot # 260980)
MHRA MHRA Boston Scientific Hong Kong Ltd MHRA Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada MHRA MHRA MHRA MHRA FDA FDA
MDA/2009/041 2009/006/010/291/016 N.A. 2009/005/013/081/008 46444 47925 45984 48498 48480 48447 48674 48488 2009/006/011/601/001 2009/006/008/291/014 2009/006/008/291/013 2009/005/020/291/005 Z-1437-2009 to Z-1443-2009 Z-1419-2009 to Z-1420-2009 Z-1416-2009 Z-1453-2009 to Z-1469-2009 2009/006/002/081/003 2009/006/009/081/006 2009/006/011/291/002 2008-011-013-301-001 2009/006/012/291/005 2009/005/028/051/014 2009/006/017/601/003, 2009/006/024/601/001 2009/004/023/301/001
MDA FSCA Firm Initiated Field Action FSCA Type II Type II Type II Type II Type II Type II Type II Type II FSCA FSCA FSCA FSCA Class II Class II Class II Class II FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA
2009/06/23 2009/06/23 2009/06/22 2009/06/24 2009/06/25 2009/06/25 2009/06/25 2009/06/25 2009/06/25 2009/06/25 2009/06/25 2009/06/25 2009/06/25 2009/06/25 2009/06/25 2009/06/25 2009/06/26 2009/06/26 2009/06/26 2009/06/26 2009/06/26 2009/06/26 2009/06/26 2009/06/26 2009/06/29 2009/06/29 2009/06/29 2009/06/29
N.A. N.A. Boston Scientific Hong Kong Ltd Philips Health Care (Great China) TERUMO CHINA (H.K.) LTD. N.A. GE Medical Systems Hong Kong Ltd. Stryker China Ltd N.A. N.A. N.A. N.A. N.A. Siemens Healthcare Diagnostic Limited Siemens Healthcare Diagnostic Limited N.A. Siemens Healthcare Diagnostic Limited Johnson & Johnson Hong Kong Ltd AR Burkill & Sons (HK) Ltd N.A. GE Medical Systems Hong Kong Ltd. TERUMO CHINA (H.K.) LTD. Siemens Healthcare Diagnostic Limited N.A. Johnson & Johnson Medical (HK) N.A. N.A. N.A.
N.A. N.A. 2960 7136 2821 5480 2866 0811 N.A. 2783 1838 2518 6915 N.A. N.A. N.A. N.A. N.A. 2810 7533 2810 7533 N.A. 2810 7533 2738 6027 2541 1041 N.A. 2783 1838 2866 0811 2810 7533 N.A. 2738 6027 N.A. N.A. N.A.
SN0906114 MedovationsInsufflation Tubing With Filter (Model no SU1101) Medical Devices Group Computer treatment planning release SN0906115 4.34.00 through 4.40.00 SN0906116 SN0906117 SN0906118 Siemens Artiste digital linear accelerators with syngo RT Therapist version 4.1 connected to LANTIS Siemens Artiste digital linear accelerator with syngo RT Therapist Version 4.1 build 67 and build 122 PENTAX Suction Valve (Types, Of-B136, Of-B140, Of-B163, OfB179 in endoscopy)
SN0906119 Siemens Mavig Portegra 2 Advanced Sterilization Products (JNJ) STERRAD 50 Sterilization SN0906120 System (Product Code 10050) and STERRAD NX Sterilization System (Prodoct Code 10033) SN0906121 Cook Medical Tao Brush I.U.M.C. Endometrial Cytology/Histology Sampler (REF J-ES-090500-BL)
FDA FDA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA
SN0906122 Bard E LUMINEXX Biliary Stent SN0906123 GE Signa Ovation 0.35T, GE Signa Openspeed 0.7T Terumo pre-connected haemoconcentrator with drainage bag (adult SN0906124 or paediatric) SN0906125 Siemens Advia Centaur Hepatitis B Core Total (HBcT) Assay SN0906126 Ormesa New Bug SN0906127 Ethicon (JNJ) Endoloop Ligature Pds II Suture SN0906128 DxS Therascreen: EGFR29 Mutation Kit SN0906129 ThermoFisher Scientific PO0287A Yersinia Agar (CIN Med) SN0906130 Possum HC603C IR Mains Switch
Medical Device Control Office
6
Department of Health The Government of HKSAR
SN0906131 Maquet Servo 300 ventilator (SV300)
MHRA
MDA/2009/042
MDA
2009/06/30
N.A.
N.A.
Medical Device Control Office
7
Department of Health The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - May 2009
Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada Date of Issue MDCO Ref. Source of Local Agent Description of Product Reference No. by Source Alert Type by Source (YYYY/MM/DD) No. Information SN090501 SN090502 SN090503 SN090504 SN090505 SN090506 SN090507 SN090508 SN090509 SN090510 SN090511 SN090512 SN090513 SN090514 SN090515 SN090516 SN090517 SN090518 SN090519 SN090520 SN090521 SN090522 SN090523 Roche ACCU-CHEK Spirit Insulin Pump Accuray Synchrony Respiratory Tracking System Sunrise Medical Breezy 100 and Breezy 300 Elekta XVI (Synergy® kV Detector) Great Bear cubCATH Intermittent Catheter AVP10 Maquet MEDAP BORA UP 2080 Universal suction pump Nucletron Oncentra Prostate CT/MR option Medtronic Sprinter OTW Product (TPL 970) Stryker PainPump2 Cardinal Health Alaris Patient-Controlled Analgesia (PCA) Module (Model 8120) Siemens Syngo Imaging (Model# 10 014 063) Tri-State Centurion Products Wright Medical Screwdriver for 3.5mm Screws (DARCO System, REF: DC4261) Hill-Rom TotalCare Bed (Model P1900) Medtronic Model 37085 Restore 1x4 DBS Extension Kit Smith & Nephew Blades Invacare XLT Self Propelling Wheelchair with rear wheels set back anti tipper Biosite Triage Cardiac Panel Boston Scientific Safety and Standard Push PEG Kits Boston Scientific Neuroform3 Microdelivery Stent System Smith & Nephew Reflection Microstable Acetabular Liner (REF 71740250) BD Insuline Syringe (Cat no. 328420) Molift Smart FDA MHRA MHRA MHRA MHRA MHRA MHRA Medtronic International Ltd FDA FDA FDA FDA FDA FDA Medtronic International Ltd Smiths & Nephew Ltd MHRA FDA Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd Smiths & Nephew Ltd BD MHRA N.A. 2009/004/017/061/012 2008/006/025/261/001 2009/003/011/061/002 2009/003/025/061/007 2009/003/025/061/017 2009/004/022/291/006 N.A. Z-1182-2009 to Z-1194-2009 Z-1237-2009 Z-1235-2009 Z-1319-2009 to Z-1322-2009 Z-1208-2009 Z-1317-2009 N.A. N.A. 2008/011/010/061/017 Z-1391-2009 N.A. N.A. Z-1004-2009 N.A. 2009/001/020/301/001 Press Release FSCA FSCA FSCA FSCA FSCA FSCA Firm Initiated Field Action Class II Class II Class II Class II Class II Class II Firm Initiated Field Action Firm Initiated Field Action FSCA Class I Firm Initiated Field Action Firm Initiated Field Action Firm Initiated Field Action Firm Initiated Field Action FSCA 04-May-09 04-May-09 04-May-09 04-May-09 04-May-09 04-May-09 04-May-09 05-May-09 07-May-09 07-May-09 07-May-09 07-May-09 07-May-09 07-May-09 07-May-09 07-May-09 08-May-09 11-May-09 11-May-09 11-May-09 11-May-09 13-May-09 13-May-09 Roche Diagnostics (Hong Kong) Ltd Accuray Asia Ltd N.A. N.A. N.A. Maquet Hong Kong Ltd N.A. Medtronic International Ltd. Stryker China Ltd Cardinal Health Siemens Healthcare Diagnostic Limited N.A. Starry Medical Technology, Ltd N.A. Medtronic International Ltd. Smith & Nephew LTD N.A. Biosite Incorporated Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd Smith & Nephew Ltd BD N.A. Agent Contact Telephone No 2485 7510 2247 8628 N.A. N.A. N.A. 2393 9511 N.A. 2919 1362 2518 6915 N.A. 2810 7533 N.A. 2961 4503 N.A. 2919 1362 9651 5523 N.A. 2855 6883 2960 7136 2960 7136 2648 7700 2575 8668 N.A.
Medical Device Control Office
8
Department of Health The Government of HKSAR
SN090524 SN090525 SN090526 SN090527 SN090528 SN090529
ThermoFisher TPHA Test Kit.
MHRA
2009/004/028/061/014 N.A. Z-1233-2009 Z-1232-2009 Z-1328-2009 N.A.
FSCA Firm Initiated Field Action Class II Class II Class II Firm Initiated Field Action
13-May-09 13-May-09 14-May-09 14-May-09 14-May-09 15-May-09
N.A. Johnson & Johnson Medical (HK) Siemens Healthcare Diagnostic Limited GE Medical Systems Hong Kong Ltd. N.A. Varian Medical Systems Pacific Inc.
N.A. 2738 6027 2810 7533 2783 1838 N.A. 2724 2836
Johnson & Johnson Cordis Cypher Select Sirolimus Eluting Coronary Stents (Hub Crack) Medical (HK) Siemens Mammomat Novation DR (Model No. 06646900) GE Healthcare CIC Pro" Software Versions 5.0.3, 5.0.6, 5.0.7, 5.0.8 and 4.1 Nova Biomedical Stat Profile Critical Care Xpress (CCX and CXX+), CCX Creatinine Membrane Kit for CCX analyzer (Catalog # 35238) Varian 4DITC Version 8.1x or Varian Treatment (VT) for Elekta, Siemens and GE Saturne Linacs Versions 6.6.5046 and 6.6.5048 with ARIA Server versions 8.1.15, 8.5.11 and 8.6.07 Bard Truguide Coazial Biopsy Needle (Model: C4140A, C1810B, C1813B, C1816B, C1820B, C2013B, C2016B, C2020B) Stryker Restoration Modular Cone Bodies (Model: 6276-1-121, 6276-1-125, 6276-1-219, 6276-1-325) Boston Scientific Percutaneous combination stent (Model: 410-111, 112, 126, 202-207, 304-305) UNOMEDICAL Paradigm Silhouette Infusion Set (Model: MMT377600, 378600, 381600, 382600) Norwex Silvercare Toothbrush (Model: 22963) Spacelabs Medical Medical Flat Panel Power Supply (Model: 0101619-00, 010-1655-00) Beckman Coulter Flow-set Fluorospheres (Model: 6607007) Biomet Orthopedics C2A Ringloc Acetabular System - 28 mm (Model: 12-115112) Biomet Microfixation Byrd Screw 2.0x6mm Self Drilling (Model: 010267) Bard Max-Core Disposable Bipsy Instr. (Model: MC1810, MC1816, MC1820) Beckman Coulter Access Systems Total BHCG Reagent Kit (Model: 33500) Arrow International A) Percutaneous Sheet, B) Central Venous Catheterization Set/Kit, C) Temporary Pacing Catheter, D) Twolumen Central Catheterization Kit, E) Percutaneous Sheath Introducers Sets, F) Stopcocks, G) Arterial Access Products, H) Thrombolic Device Rotator Drive Unit, I) Tretorola Percutaneous Thombolic Device, J) Percutaneous Sheath Introducer, K) Super Arrow-Flex Percut Sheath Intro, L) Stopcock with Luer Lock, M) Stopcock Manifold, N) Multi-Lumen Percut Sheath Introducer, O) Stopcock with Luer Lock, P) Stopcock with Luer Lock, Q) Blood Administration Sets, R) Extension Sets, S) Trerotola Percut. Thrombolytic Kit Medxi Heparin pre-filled syringes (Model: 3706, 3780, 3781, 3786, 3787), Saline pre-filled syringes )3704, 37043, 37043B, 37043B, 37043BNC, 3705C, 3705NC, 3706) FDA FDA FDA Varian Medical Systems Pacific Inc. Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada
SN090530 SN090531 SN090532 SN090533 SN090534 SN090535 SN090536 SN090537 SN090538 SN090539 SN090540
47695 47576 47581 47734 47238 47582 47347 47389 46721 47251 47348
Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II
14-May-09 14-May-09 14-May-09 15-May-09 15-May-09 15-May-09 15-May-09 15-May-09 15-May-09 15-May-09 15-May-09
N.A. Stryker China Ltd Boston Scientific Hong Kong Ltd N.A. N.A. N.A. Beckman Coulter Hong Kong Ltd N.A. N.A. N.A. Beckman Coulter Hong Kong Ltd
N.A. 2518 6915 2960 7136 N.A. N.A. N.A. 2240 6150 N.A. N.A. N.A. 2240 6150
SN090541
Health Canada
46908
Type II
15-May-09
N.A.
N.A.
SN090542
Health Canada
47632
Type II
15-May-09
N.A.
N.A.
Medical Device Control Office
9
Department of Health The Government of HKSAR
SN090543 SN090544 SN090545 SN090546
Ace Surgical Supply 5/0 Polyglycolic Acid Absorbable Suture (Model: 34630) Wallac OYT Neogram Amino Acids Mass Spec Kit Philips Holter B. Braun IV set with Universal Spike, 2 Ultrasite (Model: 352079/CSP152VSL), Primary IV Set with 3 Ultrasite (Model: 352049, 375100) BMH Medical Combi Sling (626002), Sling Deluxe Child (626002C), Sling Mesh Deluxe Child (626002C-M), Sling Deluxe Oversize (626003), Sling Cardiac Pacemakers Cognis CRT-D HE (N106), Cognis CRT-D (N107), Teligen ICD (VR-HE DF1)(E110), Teligen ICD (DR-HE IS1)(E110) ALL Models Bioprosthetic Heart valves Medtronic Kappa 600/700/900 Series and Sigma 100/200/300 Series Pacemakers Respironics SmartMonitor 2 Infant Apnea Monitor (Models 4002 and 4003) BD 20ml Luer-Lok Syringe (Recorder Number 309661) Roche MagNA Pure LC Workstation GE Centricity TriWin Laboratory Information System Varian Acuity (Auto-fit MLC feature) Varian Acuity (Changes to Asymmetric and Symmetric Field Axis Properties During Verification Simulation Boston Scientifc FORTE GUIDE WIRE Radiometer Medical ABL800 Flex analyser ThermoFisher Scientific Columbia Blood Agar PB0122A Trinity Biotech TriniCLOT aPTT S Biomet Orthopedics Offset tibial tray adaptor 5.0mm Unisurge OP-Flex Poole (handle set) contained within Procedure Packs Integra LifeScience Licox Oxygen Catheter Micro-Probes (models CC1 and CC1.2) Oxoid (Ely) ProSpecT Adenovirus R240096 Siemens Dimension Enzymatic Creatinine Flex Reagent Cartridge Biomet Microfixation Lactosorb Pectus Stabiliser
Health Canada Health Canada Health Canada Health Canada
47393 47714 47704 47750
Type II Type II Type II Type II
15-May-09 15-May-09 15-May-09 15-May-09
N.A. N.A. Philips Health Care (Great China) B. Braun Medical Hong Kong
N.A. N.A. 2821 5480 2277 6125
SN090547
Health Canada
47789
Type II
15-May-09
Arjo Huntleigh (Hong Kong) Ltd.
2508 1416
SN090548 SN090549 SN090550 SN090551 SN090552 SN090553 SN090554 SN090555 SN090556 SN090557 SN090558 SN090559 SN090560 SN090561 SN090562 SN090563 SN090564 SN090565 SN090566
Health Canada MHRA Medtronic International Ltd. FDA BD FDA FDA Varian Medical Systems Pacific Inc. Varian Medical Systems Pacific Inc. Boston Scientific Hong Kong Ltd MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA
47936 MDA/2009/032 N.A. Z-1411-2009 N.A. Z-1255-2009 Z-1397-2009 N.A. N.A. N.A. 2009/004/021/061/004 2009/004/023/601/001 2009/004/028/061/018 2009/003/005/601/002 2009/003/020/061/016 2009/004/024/051/001 2009/004/023/601/003 2009/004/027/291/022 2009/004/015/601/003
Type II MDA Firm Initiated Field Action Class I Firm Initiated Field Action Class II Class II Firm Initiated Field Action Firm Initiated Field Action Firm Initiated Field Action FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA
15-May-09 18-May-09 19-May-09 19-May-09 19-May-09 21-May-09 21-May-09 21-May-09 22-May-09 22-May-09 25-May-09 25-May-09 25-May-09 25-May-09 25-May-09 25-May-09 25-May-09 25-May-09 25-May-09
Boston Scientific Hong Kong Ltd N.A. Medtronic International Ltd. Celki Medical Company BD Roche Diagnostics (Hong Kong) Ltd GE Medical Systems Hong Kong Ltd. Varian Medical Systems Pacific Inc. Varian Medical Systems Pacific Inc. Boston Scientific Hong Kong Ltd N.A. N.A. N.A. N.A. N.A. N.A. Hong Kong South East Chemicals & Instruments Ltd Siemens Healthcare Diagnostic Limited N.A.
2960 7136 N.A. 2919 1362 2268 9258 2575 8668 2485 7510 2783 1838 2724 2836 2724 2836 2960 7136 N.A. N.A. N.A. N.A. N.A. N.A. 2802 6333 2810 7533 N.A.
Medical Device Control Office
10
Department of Health The Government of HKSAR
SN090567 SN090568 SN090569 SN090570
Trinity Biotech Captia Measles IgM ELISA test kit Stanmore Implants METS Modular Tumour System KeyMed, Olympus, Aloka Endoscope - MU-1 Edwards Lifesciences Aquarius systems GEF08200, GEF09500, GEF09600, GEF09700 Roche cobas 6000 analyzer series (including cobas c 501 and cobas e601 modules) Middleware Solutions instrument Manager Standard and Middleware Solutions instrument Manager Server GE Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging System Bio-Rad Variant II Hemoglobin Testing System with CDM v 4.0 (model no 270-2000) Remel Staphaurex Plus Kit (Catalog. no. R30950102 and R30950201) BD Insyte Autoguard IV Catheter (Cat. No. 381812; Lot no. 8171780) Smith & Nephew DYONICS 25 tubeset kits (Cat no. 7211005; 7211006) Cardinal Health Esteem Blue with Neu-Thera Polyisoprene Surgeon Gloves Wright Medical Darco Cannulated Hex Driver Rocialle InHealth Procedure Packs containing Suction Catheter
MHRA MHRA MHRA MHRA
2009/004/017/061/009 2009/004/009/061/008 2008/012/023/601/003 2009/004/006/291/009
FSCA FSCA FSCA FSCA
25-May-09 25-May-09 25-May-09 25-May-09
N.A. N.A. N.A. N.A.
N.A. N.A. N.A. N.A.
SN090571 SN090572 SN090573 SN090574 SN090575 SN090576 SN090577 SN090578 SN090579
FDA FDA FDA FDA BD Smiths & Nephew Ltd MHRA MHRA MHRA
Z-1393-2009 to Z-1394-2009 Z-1195-2009 Z-1395-2009 Z-1400-2009 N.A. N.A. 2009/005/007/051/005 2009/003/003/291/016 2009/005/013/291/002
Class II Class II Class II Class II Firm Initiated Field Action Firm Initiated Field Action FSCA FSCA FSCA
29-May-09 29-May-09 29-May-09 29-May-09 29-May-09 29-May-09 29-May-09 29-May-09 29-May-09
Roche Diagnostics (Hong Kong) Ltd GE Medical Systems Hong Kong Ltd. Bio-Rad Pacific Ltd. Hong Kong South East Chemicals & Instruments Ltd BD Smith & Nephew LTD N.A. Starry Medical Technology, Ltd N.A.
2485 7510 2783 1838 N.A. 2802 6333 2575 8668 2648 7700 N.A. 2961 4503 N.A.
Medical Device Control Office
11
Department of Health The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - April 2009
Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada Date of Issue MDCO Ref. Source of Local Agent Description of Product Reference No. by Source Alert Type by Source (YYYY/MM/DD) No. Information SN090401 SN090402 SN090403 SN090404 SN090405 SN090406 SN090407 SN090408 SN090409 SN090410 SN090411 SN090412 SN090413 SN090414 SN090415 SN090416 SN090417 SN090418 SN090419 SN090420 SN090421 SN090422 SN090423 Tri-State Centurion Products Roche COBAS c 11 Analyzer with ISE Module option, GMMI No. 04777433001 Bio-Rad Variant II TURBO Hemoglobin Testing System with CDM V 4.0, MODEL NO 270-2600 Stryker Impaction Bur Guard REF 2296-301, 2296-300, 0260-901300 and 5400-300 Lecia QCA and iQCA software DiaSorin LIASON ® Chemiluminescence Analyzer Model #15970 Colorimeter, Photometer, Spectrophotometer for clinical use Medtronic Physio-Control Bisphasic LIFEPAK® 12 Defibrillator/monitor 3M No Sting Barrier Film (Model 3346E) GE Healthcare ViewPoint Image Archiving and Reporting System Gas Control Equipment Sabre Therapy Probe Regulator CODAN Burette Sets Roche Ambulatory insulin infusion pump. Accu-Chek Spirit Biomet Biolox Delta Ceramic Heads 28mm, +5mm (T1 taper) ThermoFisher Columbia blood agar - PB0122A GE Healthcare S/5 iCentral and iCentral Client (L-NET05 and LNETC05) Stryker Electric Stretcher with the Quick Drop CPR option (Model 1050 and Model 1550) Stelkast Dual Taper Wedge Pressed Fit Femoral Component Zues Scientific Sm ELISA Test System (Product no.: 2Z2831G and 43270CE) Trumpf Medical ILED Surgical Light (Model no ILED3, ILED5 and ILED5K) Theragenics Spacers of varying lengths Johnson and Johnson Ethicon Endo-Surgery Device - Ets-FLEX45 Tepnel Quick-Type for LIFEMATCH Update CD Teleflex Medical (Arrow) 30, 40 and 50 cc Intra-Aortic Ballloon FDA FDA FDA FDA FDA FDA Medtronic International Ltd 3M MHRA MHRA MHRA MHRA MHRA MHRA FDA FDA FDA FDA FDA FDA Johnson & Johnson Medical (HK) MHRA FDA N.A. Z-1009-2009 Z-1041-2009 Z-1052-2009 Z-1040-2009 Z-1042-2009 N.A. N.A. 2009/001/007/401/004 2009/003/024/291/011 2009/003/023/291/013 MDA/2009/024 2009/003/017/061/004 2009/003/024/601/003 Z-1039-2009 Z-1230-2009 to Z-1231-2009 Z-1073-2009 Z-1089-2009 Z-1122-2009 Z-1020-2009 N.A. 2009/003/026/601/014 Z-1210-2009 to Z-1222-2009 Class I Class II Class II Class II Class II Class II Firm Initiated Field Action Firm Initiated Field Action FSCA FSCA FSCA MDA FSCA FSCA Class II Class II Class II Class II Class II Class II Firm Initiated Field Action FSCA Class I 2009/04/02 2009/04/02 2009/04/02 2009/04/02 2009/04/02 2009/04/02 2009/04/02 2009/04/03 2009/04/06 2009/04/06 2009/04/06 2009/04/07 2009/04/07 2009/04/07 2009/04/14 2009/04/14 2009/04/14 2009/04/14 2009/04/14 2009/04/14 2009/04/14 2009/04/15 2009/04/16 N.A. Roche Diagnostics (Hong Kong) Ltd Bio-Rad Pacific Ltd. Stryker China Ltd Leica Microsystems Ltd N.A. Medtronic International Ltd. 3M GE Medical Systems Hong Kong Ltd. N.A. N.A. Roche Diagnostics (Hong Kong) Ltd N.A. N.A. GE Medical Systems Hong Kong Ltd. Stryker China Ltd N.A. N.A. TRUMPF China (Hong Kong) Ltd. N.A. Johnson & Johnson Medical (HK) N.A. N.A. Agent Contact Telephone No N.A. 2485 7510 N.A. 2518 6915 2564 6699 N.A. 2919 1362 2806 6349 2783 1838 N.A. N.A. 2485 7510 N.A. N.A. 2783 1838 2518 6915 N.A. N.A. 2880 9808 N.A. 2738 6027 N.A. N.A.
Medical Device Control Office
12
Department of Health The Government of HKSAR
SN090424 SN090425 SN090426 SN090427 SN090428 SN090429 SN090430 SN090431 SN090432 SN090433 SN090434 SN090435 SN090436 SN090437 SN090438 SN090439 SN090440 SN090441 SN090442 SN090443 SN090444 SN090445 SN090446
Cardinal Health (Viasys Healthcare) Sonora Transcranial Doppler (TCD) System (Model Sonara, Part no 982A0469 and 982A0470) Biomet Offset Tibial Tray Adaptor, 5.0 MM, Sterile, REF 141491 Abbott CELL-Dyn Ruby Hematology Analyzer (List no 08H67-01) Roche/Hitachi Modular Analytics System (Modular D2400 Module; P800 Module; D Module; D Module) Boston Scientific Convoy Advanced Delivery Sheath Kit and Soft Tip Sheath Multipurpose Introducing Sheath Kit GE Healthcare Infinia Hawkeye and Hawkeye 4 GE Healthcare Infinia, Hawkeye for Infinia and Infinia Hawkeye 4 Cardinal Health ReadyMed Elastomeric Ambulatory Pump Medtronic Physio Control Internal Sterilizable Paddles and Handles without discharge control for use with LIFEPAK 9 and LIFEPAK 9P defibrillators/monitors Bard Dual Port Wizard Low Profile Replacement Gastrostomy Device Integra Bilayer Matrix Wound Dressing, 8" x 10" (20cm x 25cm); Non-pyrogenic diaDexus PLAC Test Reagent Kit (Catalog no 90110) Teleflex Medical Pilling Coronary Scissors (Cataolg no 352164352169 & 352178) Siemens HM Reaction Vessels (RXV1A) i-sens Caresens II BGM Sybron Pitt Easy Implant James Leckey EAS Floor Mat Homecraft Rolyan Frimley folding stool model AA1550 Stryker Modular Replacement System (MRS) Cemented Stems Stryker AxSOS T8 Screwdriver and AxSOS Torque Limiting Screwdriver Stryker Trio Small Offset Connector Non Sterile (Catalog no 48902015) GE Healthcare Infinia, Infinia Hawkeye and Infinia Hawkeye 4 Abbott AxSYM HBsAg Reagent Pack, AxSYM CMV IgG Regent Pack, AxSYM CORE 2.0 Reagent Pack, AxSYM Folate Reagent Pack, AxSYM Myoglobin Reagent Pack and AxSYM Troponin-I ADV Reagent Pack Maquet ALM Prismatic Surgical Light 9551 DF and ALM Prismatic Surgical Light 54004 SF Cardiovascular System DiamondBack 360, CSI ViperWire Orbital Atherectomy Guide Wire (REF: GW14335FRM) St.Jude Medical EP-4 Stimulator 2 and 4 channels and EP WorkMate containing the EP4 stimulator
FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA MHRA Others MHRA MHRA MHRA FDA FDA FDA FDA FDA
Z-0998-2009 to Z-0999-2009 Z-1061-2009 Z-1064-2009 Z-1065-2009 to Z-1068-2009 Z-1071-2009 to Z-1072-2009 Z-1094-2009 to Z-1095-2009 Z-1119-2009 to Z-1121-2009 Z-1170-2009 Z-1171-2009 Z-1096-2009 to Z-1117-2009 Z-1174-2009 Z-1204-2009 Z-1175-2009 to Z-1181-2009 2008/012/002/061/010 N.A. 2008/012/002/061/010 2009/003/016/301/002 2009/001/030/401/010 Z-1251-2009 Z-1062-2009 to Z-1063-2009 Z-0986-2009 Z-1001-2009 to Z-1003-2009 Z-1046-2009 to Z-1051-2009
Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II FSCA N.A. FSCA FSCA FSCA Class II Class II Class II Class II Class II
2009/04/16 2009/04/16 2009/04/16 2009/04/16 2009/04/16 2009/04/16 2009/04/16 2009/04/16 2009/04/16 2009/04/16 2009/04/16 2009/04/16 2009/04/16 2009/04/16 2009/04/17 2009/04/20 2009/04/22 2009/04/22 2009/04/23 2009/04/23 2009/04/23 2009/04/23 2009/04/23
Cardinal Health N.A. Abbott Laboratories LTD. Roche Diagnostics (Hong Kong) Ltd Boston Scientific Hong Kong Ltd GE Medical Systems Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. Cardinal Health Medtronic International Ltd. N.A. N.A. N.A. N.A. Siemens Healthcare Diagnostic Limited BioScan Ltd N.A. N.A. N.A. Stryker China Ltd Stryker China Ltd Stryker China Ltd GE Medical Systems Hong Kong Ltd. Abbott Laboratories LTD.
N.A. N.A. 2593 2211 2485 7510 2960 7136 2783 1838 2783 1838 N.A. 2919 1362 N.A. N.A. N.A. N.A. 2810 7533 3589 6670 N.A. N.A. N.A. 2518 6915 2518 6915 2518 6915 2783 1838 2593 2211
SN090447 SN090448 SN090449
FDA
Z-1153-2009 to Z-1154-2009 Z-1250-2009 2009/003/030/061/008
Class II Class II FSCA
2009/04/23 2009/04/23 2009/04/23
Maquet Hong Kong LTD. N.A. N.A.
2393 9511 N.A. N.A.
FDA MHRA
Medical Device Control Office
13
Department of Health The Government of HKSAR
SN090450 SN090451 SN090452 SN090453 SN090454 SN090455 SN090456 SN090457
Philips HeartStart XL M4735A Defibrillator/Monitor Philips HeartStart MRx/MRxE M3535A/M3536A/M3536J Defibrillator/Monitor ThermoFisher BO0332D Ringers Solution 1/4 Strength lot 1067747 Stryker Restoration Modular Cone Bodies Abbott Hematology Reagent Syringe (List no 08H49-02) Berchtold Operon Electrical Operating Room Table Pointe Scientific Liquid Auto HDL CHolesterol Reagent Set DiaDexus PLAC Test Calibrator Kit (Catalog No. 90108 and 100108)
Philips Health Care (Great China) Philips Health Care (Great China) MHRA MHRA FDA FDA FDA FDA
N.A. N.A. 2009/001/029/601/001 2009/003/025/291/008 Z-1069-2009 Z-1123-2009 Z-1200-2009 to Z-1201-2009 Z-1205-2009
Firm Initiated Field Action Firm Initiated Field Action FSCA FSCA Class II Class II Class II Class II
2009/04/23 2009/04/23 2009/04/29 2009/04/29 2009/04/30 2009/04/30 2009/04/30 2009/04/30
Philips Health Care (Great China) Philips Health Care (Great China) N.A. Stryker China Ltd Abbott Laboratories LTD. N.A. N.A. N.A.
2821 5226 2821 5226 N.A. 2518 6915 2593 2211 N.A. N.A. N.A.
Medical Device Control Office
14
Department of Health The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - March 2009
Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada Date of Issue MDCO Ref. Source of Local Agent Description of Product Reference No. by Source Alert Type by Source (YYYY/MM/DD) No. Information SN090301 SN090302 SN090303 SN090304 SN090305 SN090306 SN090307 SN090308 SN090309 SN090310 SN090311 SN090312 SN090313 SN090314 SN090315 SN090316 SN090317 SN090318 SN090319 SN090320 SN090321 SN090322 SN090323 SN090324 SN090325 Draeger Medical Oxylog 3000 Ventilator (2M86955) Oxoid Limited Oxoid Fraser Broth Base (CM0895B) Biomet Modular Microplasty Cup Inserter Miltex Stainless Steel Surgical Blades Ohio Willow Wood Duralite Pyramid Receiver Proximal Adapter (FND-136102) GE Diamond Mammography X-Ray Equipment (81000) GE Datrex-Ohmeda Network and Icentral (M1113714, M1113715) Stryker (Howmedica Osteonics) Securefit Hip Stem - 132 degree, Securefit Hip Stem - 127 degree, Solar Shoulder - Humeral Component, Ostenoics Omnifit Hip Stem Stryker (Howmedica Osteonics) Osteonics Omnifit M-HA Hip Stem, Accolade TMZF Press Fit Stem 132 Degree, Accolade TMZF Press Fit Stem 127 Degree GE OEC Mobile Elite C-Arms Gen. Platform, OEC Mobile Elite Arms Cooling Siemens Immulite 2000 system-analyzer class III & II, Immulite 2000 - Instrument Class IV Philips Gemini GXL 6/10/16 Slice PET/CT, Gemini TF 16 PET?CT system, Gemini TF 64 PET/CT System Draeger Evita 4, Evita 2 Dura, Evita XL DORC international MembraneBlue© 0.5ml syringe Philips Diagnostic Ultrasound System (Model HD3 and HDI4000) Medtronic Surgical Membrane Oxygenator Stryker Endoscopy brand 3.5mm Super 90-S SERFAS Enegry Suction Probe (Model no 279-351-200) Abbott ACCELERATOR APS Centrifuge Module (Hettich Robotic centrifuge) (List no: 07L02-01) Abbott Architect / Aeroset Clinical Chemistry Iron/Magnesium Calibrator (List No. 1E69-03) Terumo Advanced Perfusion System 1 Excelsior Medical Sterile Field Saline Flush (Product codes: E0100 20, 100 92-240 and 100 92-30) Cook Medical Universa Soft Ureteral Stent and Positioner with Hydrophillic Coating (REF USH-526-R, GPN REF G49966) Welch Allyn AED 10 and former MRL Jumpstart Automated External Defibrillators Medtronic Physio-Control Lifepak 20 defibrillator/monitor - Keypad Sunrise Medical Quickie Groove battery powered wheelchairs Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada MHRA FDA FDA FDA FDA FDA FDA FDA FDA Welch Allyn Medtronic International Ltd MHRA 44596 45182 43310 46242 44165 44731 44822 44184 45981 44335 46193 46137 42978 MDA/2009/017 Z-0522-2009 to Z-0523-2009 Z-0975-2009 Z-0972-2009 Z-0951-2009 Z-0950-2009 Z-0909-2009 to Z-0910-2009 Z-0973-2009 Z-0980-2009 N.A. N.A. MDA/2009/018 Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II MDA Class II Class II Class II Class II Class II Class II Class II Class II Firm Initiated Field Action Firm Initiated Field Action MDA 2009/03/03 2009/03/03 2009/03/03 2009/03/03 2009/03/03 2009/03/03 2009/03/03 2009/03/03 2009/03/03 2009/03/03 2009/03/03 2009/03/03 2009/03/03 2009/03/04 2009/03/05 2009/03/05 2009/03/05 2009/03/05 2009/03/05 2009/03/05 2009/03/05 2009/03/05 2009/03/05 2009/03/10 2009/03/10 N.A. South East Chemicals & Instruments Ltd N.A. N.A. N.A. GE Medical Systems Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. Stryker China Ltd Stryker China Ltd GE Medical Systems Hong Kong Ltd. Siemens Healthcare Diagnostic Limited Philips Health Care (Great China) N.A. N.A. Philips Health Care (Great China) Medtronic International Ltd. Stryker China Ltd Abbott Laboratories LTD. Abbott Laboratories LTD. TERUMO CHINA (H.K.) LTD. N.A. N.A. N.A. Medtronic International Ltd. N.A. Agent Contact Telephone No N.A. N.A. N.A. N.A. N.A. 2783 1838 2783 1838 2518 6915 2518 6915 2783 1838 2810 7533 2821 5480 N.A. N.A. 2821 5480 2919 1362 2518 6915 2593 2211 2593 2211 2866 0811 N.A. N.A. N.A. 2919 1362 N.A.
Medical Device Control Office
15
Department of Health The Government of HKSAR
SN090326 SN090327 SN090328 SN090329 SN090330 SN090331 SN090332 SN090333 SN090334 SN090335 SN090336 SN090337 SN090338 SN090339 SN090340 SN090341 SN090342 SN090343 SN090344 SN090345 SN090346 SN090347 SN090348 SN090349 SN090350 SN090351 SN090352
CMS Software 4.3.1 through 4.40.00 Cardiac Science Powerheart and First Save AED InteliFUSE Drill Bit (REF: DB.150.JL and DB.200.JL) Johnson and Johnson (Animas) Meter Remote for OneTouch Ping Glucose Management System Zimmer Orthosoft Navitrack, OS Unicodylar Knee 1.0- Universal Stryker Triathlon X3 Posterior Stabilized Tibial Insert Use with Triathlon PS Femoral Components (Catalog no 5532-G-713 & 5532G-813) Medtronic VARI-STIM III Nerve Locator/Stimulator Hospira Symbiq One-Channel (List no 16026-04) and Two-Channel (list no 16027-04) Infusion System GE Healthcare Innova Biplane 3131 Zimmer NCB cancellous screw 4.5mmx 48mm Self tapping VYGON PROTECT-A-SPIRAL ­ 300CM IPSOGEN JAK2 MutaScreen Kit Philips Multi Diagnost Eleva FD - Leaking X-Ray Tube Grid Boston Scientific Wiseguide Guide Catheter BD Falcon 100 x 20 mm Tissue Culture - Treated Dish (BD Cat no 353003) Unihoist University Bath Hoist and University Bath Hoist Transporter Stryker Triathlon Primary Stryker Triathlon Primary Cemented Baseplate (5520-B-400) Smith & Nephew Tandem Unipolar 46 mm Femoral Heads (126646) Zimmer Minimally Invasive Solutions Technology Offset RASP Handles Technidata Logiciel TDHIsto/CytoSoftware Computerized Medical Systems Focal Software CD Bard Fantrac "Paul" Gastric Access Port Kit (Model 5729) Genzyme Diagnostics Enzymatic Creatinine Assay Nipro Blood Tubing Set for Hemodialysis (A230TR/V810TR) Armstrong Medical Amsorb Plus Prefilled Bubble-Can Universal WTOV Cardinal Health Sterile Pacemaker and Defibrillator Pack (SAN30PAXXX), Sterile Shoulder Pack (SOP30ASXXX) PDSII Monofilament suture, Coated Vicryl Absorable Suture, PDS II Suture, Monocryl Plus Antibacterial Suture, Coated Vicryl Plus Antibacterial Ethicon Suture
MHRA FDA FDA FDA FDA FDA FDA FDA MHRA MHRA MHRA MHRA MHRA Boston Scientific Hong Kong Ltd BD MHRA Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada
2009/002/015/601/001 Z-0916-2009 to Z-0922-2009 Z-1032-2009 to Z-1033-2009 Z-0955-2009 Z-0985-2009 Z-1013-2009 Z-0947-2009 Z-0944-2009 2008/006/013/601/413 2009/002/020/291/022 2009/002/026/601/003 2009/002/010/291/016 2008/011/020/061/028 N.A. N.A. 2008/011/006/301/002 46302 46208 46556 46270 44729 46521 45860 46641 45627 46652 46636
FSCA Class II Class II Class II Class II Class II Class II Class II FSCA FSCA FSCA FSCA FSCA Firm Initiated Field Action Firm Initiated Field Action FSCA Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II
2009/03/10 2009/03/12 2009/03/12 2009/03/12 2009/03/12 2009/03/12 2009/03/12 2009/03/12 2009/03/13 2009/03/13 2009/03/13 2009/03/16 2009/03/16 2009/03/16 2009/03/17 2009/03/18 2009/03/18 2009/03/18 2009/03/18 2009/03/18 2009/03/18 2009/03/18 2009/03/18 2009/03/18 2009/03/18 2009/03/18 2009/03/18
N.A. N.A. N.A. Johnson & Johnson Medical (HK) Zimmer PTE Ltd. (Hong Kong branch) Stryker China Ltd Medtronic International Ltd. Hospira Limited GE Medical Systems Hong Kong Ltd. Zimmer PTE Ltd. (Hong Kong branch) N.A. N.A. Philips Health Care (Great China) Boston Scientific Hong Kong Ltd BD N.A. Stryker China Ltd Stryker China Ltd Smith & Nephew LTD Zimmer PTE Ltd. (Hong Kong branch) N.A. N.A. N.A. N.A. N.A. N.A. Cardinal Health
N.A. N.A. N.A. 2738 6027 2992 0968 2518 6915 2919 1362 2898 2886 2783 1838 2992 0968 N.A. N.A. 2821 5226 2960 7136 2575 8668 N.A. 2518 6915 2518 6915 N.A. 2992 0968 N.A. N.A. N.A. N.A. N.A. N.A. N.A.
SN090353
Health Canada
46404
Type II
2009/03/18
Johnson & Johnson Medical (HK)
2738 6027
Medical Device Control Office
16
Department of Health The Government of HKSAR
SN090354
SN090355 SN090356 SN090357 SN090358 SN090359 SN090360 SN090361 SN090362 SN090363 SN090364 SN090365 SN090366 SN090367 SN090368 SN090369 SN090370
Baxter Healthcare Colleague Volumetric Infusion Pump, Colleague 3 Volumetric Infusion Pump, Colleague Guardian Enhanced CXE Pump, Colleague Guardian Enhanced 3CXE Pump, French Colleague CXE Volumetric Pump, French Colleague 3 CXE Volumetric Pump Biomet Sports Medicine 9-10mm Ezloc Femoral Fixation Device (904781) GE Innova 3100/3100IQ and Innova 4100 /4100IQ Medtronic PROSTIVA RE Model 8929 Hand Piece Medtronic TSRH 3DX Implant Set and TSRH Spinal System Stryker Cordless Driver 3 Handpiece, Rotary Handpiece, Reciprocating Saw, Sternum Saw, Sagittal Saw and Precision Oscillating Tip Saw Zimmer Most Hinged Tibia Baseplate Spacer (REF 5020-06-001) Integra Mosail Putty and Dermal Regeneration Template-TS Pointe Scientific Glucose Oxidase Reagent Remel Wellcolex colour salmonella Kits, R30858301 (50 tests)/R30858302 ConMed Fortis II Philips GXR RF Systems with DI (EasyDiagnost Eleva) CORONA MEDICAL Patient Beds (Side Rails) GE AS/3 Anaesthesia Delivery Unit, S/5 Anaesthesia Delivery Unit, and ADU Carestation Medtronic Sprint Fidelis Lead Maquet Servo ventilators 300 and 300A Smiths Medical Near empty flag kits product code 0131-0122 and halfnut, leadscrew and flag kits product code 0131-0236 for 3000 series graseby syringe pumps GE Datex-Ohmeda Aisys and GE Datex-Ohmeda Avance Anesthesia Machines Draeger Medical Patient monitor bracket Aidapt VR231 Lenham adjustable height commode Abbott Xience V Everilimus Eluting Coronary Stent System, 2.5 x 28mm BD PrepStain System (Model no.: 799-14000-00) LifeScan (Johnson and Johnson) OneTouch SureStep Test Strips (Part no.: 020-052-01 and 010-359-04) Rochester Medical Magic3 (Intermittent Catheter) and HydroSil (Intermittent Catheter) Biosite Triage Drugs of Abuse Panel (Model No 95000) BD Insyte Autoguard Shielded IV Catheter
Health Canada
45280
Type II
2009/03/18
Baxter Healthcare Ltd
2807 8516
Health Canada FDA FDA FDA FDA FDA FDA FDA MHRA ConMed Limited Philips Health Care (Great China) CORONA MEDICAL MHRA Medtronic International Ltd MHRA MHRA
44280 Z-1092-2009 to Z-1093-2009 Z-1060-2009 Z-1014-2009 to Z-1017-2009 Z-1021-2009 to Z-1030-2009 Z-0996-2009 Z-1034-2009 to Z-1035-2009 Z-1091-2009 2009/003/006/051/003 N.A. N.A. N.A. 2009/002/013/601/003 N.A. MDA/2009/020 2009/002/020/291/012
Type II Class II Class II Class II Class II Class II Class II Class II FSCA Firm Initiated Field Action Firm Initiated Field Action Firm Initiated Field Action FSCA Firm Initiated Field Action MDA FSCA
2009/03/18 2009/03/19 2009/03/19 2009/03/19 2009/03/19 2009/03/19 2009/03/19 2009/03/19 2009/03/19 2009/03/19 2009/03/19 2009/03/20 2009/03/23 2009/03/23 2009/03/25 2009/03/25
N.A. GE Medical Systems Hong Kong Ltd. Medtronic International Ltd. Medtronic International Ltd. Stryker China Ltd Zimmer PTE Ltd. (Hong Kong branch) N.A. N.A. Hong Kong South East Chemicals & Instruments Ltd ConMed Limited Philips Health Care (Great China) N.A. GE Medical Systems Hong Kong Ltd. Medtronic International Ltd. Maquet Hong Kong Ltd GOODMAN MEDICAL SUPPLIES LTD
N.A. 2783 1838 2919 1362 2919 1362 2518 6915 2992 0968 N.A. N.A. 2802 6333 N.A. 2821 5226 N.A. 2783 1838 2919 1362 2393 9511 2332 4455
SN090371 SN090372 SN090373 SN090374 SN090375 SN090376 SN090377 SN090378 SN090379
MHRA MHRA MHRA Abbott Laboratories LTD. FDA FDA FDA FDA BD
2009/002/017/601/001 2009/003/010/051/014 2009/001/007/401/004 N.A. Z-1090-2009 Z-1070-2009 Z-1074-2009 to Z-1087-2009 Z-1088-2009 N.A.
FSCA FSCA FSCA Firm Initiated Field Action Class II Class II Class II Class II Firm Initiated Field Action
2009/03/25 2009/03/25 2009/03/25 2009/03/25 2009/03/26 2009/03/26 2009/03/26 2009/03/26 2009/03/26
GE Medical Systems Hong Kong Ltd. Draeger Medical Hong Kong Ltd. N.A. Abbott Laboratories LTD. BD Johnson & Johnson Medical (HK) N.A. Biosite Incorporated BD
2783 1838 2877-3077 N.A. 2593 2211 2575 8668 2738 6027 N.A. 2855 6883 2575 8668
Medical Device Control Office
17
Department of Health The Government of HKSAR
SN090380 SN090381 SN090382 SN090383 SN090384 SN090385
Boston Scientific Flexima and Percuflex Drainage Catheter Family (Pigtail Style) GE Mobile Care Server L-WEB05 and iCentral L-NET05 Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide and Snap Shunt Ventricular Catheter, BioGlide Novo Nordisk NovofineR Needles 31G, 0.25 mm x 6 mm lot number 08J02S AstraZeneca Nebuchamber ZOLL AED Plus Defibrillator
Boston Scientific Hong Kong Ltd MHRA FDA MHRA Astrazeneca Hong Kong Ltd Health Canada
N.A. 2008/009/018/601/004 N.A. MDA/2009/021 N.A. N.A.
Firm Initiated Field Action FSCA Class I MDA Firm Initiated Field Action Urgent Safety Information
2009/03/27 2009/03/27 2009/03/30 2009/03/30 2009/03/30 2009/03/31
Boston Scientific Hong Kong Ltd GE Medical Systems Hong Kong Ltd. Medtronic International Ltd. N.A. Astrazeneca Hong Kong Ltd Suburfarm Investment & Trading Co.
2960 7136 2783 1838 2919 1362 N.A. 2491 5206 2780 9421
Medical Device Control Office
18
Department of Health The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - February 2009
Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada Date of Issue MDCO Ref. Source of Local Agent Description of Product Reference No. by Source Alert Type by Source (YYYY/MM/DD) No. Information Medtronic SN090201 Medtronic LIFEPAK 12 and LIFEPAK 20/20e Defibrillator / Monitor N.A. Firm Initiated Field Action 2009/02/02 Medtronic International Ltd. International Ltd Beckman Coulter UniCel DxC 880i Synchron Access Clinical SN090202 2009/001/023/601/001 FSCA 2009/02/02 Beckman Coulter Hong Kong Ltd MHRA Systems SN090203 Xcelens IDEA 613XC 2009/001/026/291/003 FSCA 2009/02/02 N.A. MHRA SN090204 SN090205 SN090206 SN090207 SN090208 SN090209 SN090210 SN090211 SN090212 SN090213 SN090214 SN090215 SN090216 SN090217 SN090218 SN090219 SN090220 SN090221 SN090222 SN090223 SN090224 SN090225 SN090226 SN090227 SN090228 SN090229 Stryker GAMMA3 Trochanteric Nail 180 Operative Technique Activate Patron Bohemia TOM Cross Country Chassis James Leckey Advanced, Contoured Advanced, Squiggles Saddle and Squiggles Early Sitting Seating Sytems ThermoFisher BO0471D, 0.1% Peptone Water + 0.85% Salt ThermoFisher EB0348D, Maximum Recovery Diluent Smith & Nephew BHR BRIDGING CUP, 66MM PRODUCT CODE 74120366 Johnson and Johnson DePuy Vac-Mix plus pre-packed with Endurance Bone Cement BD FACS Sample Prep Assistant (SPA or SPA II) GE Centricity PACS RA1000 Workstation iCAD 3TP TheraMap Software and 3TP PrecisionPoint Software Virtus Expressaire, Disposable Tourniquet Cuff (Cuff type A70107010, A70107011) Fresenius Medical CombiSet True Flow Series, Hemodialysis Blood Tubing Integra Ruggles Surgical Instrument ACF Distraction Screws Sterile, Rx only (Catalog no.: R6357A, R6397A) Coloplast EasiCath intermittent urinary catheters Teleflex Medical Ligating clips Johnson and Johnson (DePuy) DNP Anatomic Fracture Repair System Smith & Nephew Compass PIP Hinge Doddmed Metrax Primedic HeartSave AED, HeartSave AED-M BD Vacutainer Plastic Sodium Heparin Blood Collection Tube with Green BD Hemogard Closure, 13 x 75 mm, 4 ml. Zimmer Coonrad/Morrey Total Elbow System Surgical Technique Johnson and Johnson STERRAD 50 Sterilization System ThermoFisher BO0348N Maximum Recovery Diluent Medtronic LIFEPAK 20 Defibrillator / Monitor Medtronic O-Arm Intraoperative Imaging System (Catalog no.: BI700-0027) Terumo Advanced Perfusion System 1 Stryker Restoration Modular Conical Distal Stem, Titanium Alloy (Catalog no 6276-7-017 (17mm); 6276-7-014 (14mm)) MHRA MHRA MHRA MHRA MHRA MHRA Johnson & Johnson Medical (HK) BD FDA FDA FDA FDA FDA MHRA MHRA MHRA Smiths & Nephew Ltd MHRA MHRA MHRA MHRA MHRA Medtronic International Ltd FDA FDA FDA 2009/001/008/291/002 2008/009/016/401/009 2008/011/027/061/008 2009/001/026/601/005 2009/001/026/601/006 2009/001/028/601/002 N.A. N.A. Z-0836-2009 Z-0653-2009 to Z-0654-2009 Z-0907-2009 to Z-0908-2009 Z-0859-2009 to Z-0860-2009 Z-0854-2009 MDA/2009/007 MDA/2009/008 2009/001/026/291/007 N.A. 2008/011/010/061/024 2009/001/030/291/008 2009/002/005/291/017 2009/001/030/291/010 2009/001/029/601/002 N.A. Z-0624-2009 Z-0670-2009 to Z-0674-2009 Z-0884-2009 FSCA FSCA FSCA FSCA FSCA FSCA Firm Initiated Field Action Firm Initiated Field Action Class II Class II Class II Class II Class II MDA MDA FSCA Firm Initiated Field Action FSCA FSCA FSCA FSCA FSCA Firm Initiated Field Action Class II Class II Class II 2009/02/02 2009/02/02 2009/02/02 2009/02/02 2009/02/02 2009/02/02 2009/02/03 2009/02/03 2009/02/05 2009/02/05 2009/02/05 2009/02/05 2009/02/05 2009/02/05 2009/02/09 2009/02/09 2009/02/09 2009/02/10 2009/02/10 2009/02/10 2009/02/10 2009/02/10 2009/02/11 2009/02/12 2009/02/12 2009/02/12 Stryker China Ltd N.A. N.A. N.A. N.A. Smith & Nephew LTD Johnson & Johnson Medical (HK) BD GE Medical Systems Hong Kong Ltd. N.A. N.A. Fresenius Medical Care Asia Pacific Ltd. N.A. N.A. N.A. N.A. Smiths & Nephew Ltd N.A. BD Zimmer PTE Ltd. (Hong Kong branch) Johnson & Johnson Medical (HK) N.A. Medtronic International Ltd. Medtronic International Ltd. TERUMO CHINA (H.K.) LTD. Stryker China Ltd Agent Contact Telephone No 2919 1350 2240 6150 N.A. 2518 6915 N.A. N.A. N.A. N.A. N.A. 2738 6027 886-2722-5660 2783 1838 N.A. N.A. 2802 2900 N.A. N.A. N.A. N.A. 9651 5523 N.A. 886-2722-5660 2992 0968 2738 6027 N.A. 2919 1362 2919 1362 2866 0811 2518 6915
Medical Device Control Office
19
Department of Health The Government of HKSAR
SN090230 SN090231 SN090232 SN090233 SN090234 SN090235 SN090236 SN090237 SN090238 SN090239 SN090240 SN090241 SN090242 SN090243 SN090244 SN090245 SN090246 SN090247 SN090248 SN090249 SN090250 SN090251 SN090252 SN090253 SN090254 SN090255 SN090256 SN090257 SN090258 SN090259
Stryker various modular components Biomet MicrofixationLactosorb System (REF: 915-1006); Lactosorb, Office Fixation Kit (REF: 915-1000); MF Set (REF: 01-6871); Office System (REF: 01-6851) Activate Hi-Lo Powered Wheelchair Invacare Flamingo Hoist Mecall UNISTAT L floor stand Vitech Scientific Starrsed Compact Interrliner BrainLAB Radiolucent Spine Reference Clamp Millipore Corporation Bioscience Simulfluor Flu A/B Immunofluor Assay (Model:3121, 5250) Baxter Healthcare Rear Case Assembly For Auto Syringe (Model: 1M8560R) Problem Solving Concepts Prosolv Cardiovascular Image and Information Management Encore Medical Modular Femoral Neck Tremblay Harrison Minute Lab PSA Semi-Quantitative Test (Model: PSD-A1, PSS-A1) Imaging Sciences International Gendex GXCB-500 Cone Beam 3-D Imaging (Model: 45997) Immucor Galileo Echo Blood Bank Analyzer Medtronic Durepair Dura Regeneration Matrix Bio-Rad Laboratories Bioplex 2200 Detector Calibration Packs Bio-Rad Laboratories Liquicheck Cardiac Markers Control LT Trilevel (145), Level 1(146), Level 2 (147), Level 3 (148), Trilevel Minipak (145x) ThermoFisher BO0351G, Tryptone soya broth, lot number 1066679 TRB Chemedica Visiol Syringe 20mg/ml BD Insyte Autogard I.V Catheter Elekta Precise Treatment Table BioMerieux Bacteriology culture medium. Chocolate agar + PolyViteX VCAT3 agar Mast Laboratories V Factor Catridges STAAR Surgical Aquaflow collagen glaucoma drainage device Spacelabs Healthcare Blease 700/900 Ventilator Sunrise Medical DeVilbiss Model 7310PR-D VacuAide Compact Suction Unit Stryker PainPump (Prodcut no.: 0500-166-025, 0500-166-050, 0500200-000; REF: 500-166-25; 500-166-50, 500-200 Stryker PainPump 2 Blockaid (REF 575-100) Stryker AVS AL Spacer Trial Inserter; Non Sterile (Catalog no 48329800) GE Centricity PACS RA1000 Workstation (for diagnostic image analysis)
FDA FDA MHRA MHRA MHRA MHRA BrainLAB Ltd Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA FDA FDA FDA FDA FDA
Z-0888-2009 to Z-0902-2009 Z-0864-2009 to Z-0867-2009 2008/010/001/061/003 2009/001/022/301/001 2008/012/030/401/007 2008/007/023/401/007 N.A. 45681 43803 46106 44847 46147 45997 45821 45672 45218 45219 2009/001/026/601/003 2008/012/023/291/008 2009/001/030/291/009 2009/002/011/291/007 MDA/2009/011 2009/002/009/601/001 2008/011/024/291/008 2009/002/005/291/006 Z-0863-2009 Z-0923-2009 to Z-0925-2009 Z-0926-2009 Z-0936-2009 Z-0928-2009
Class II Class II FSCA FSCA FSCA FSCA Firm Initiated Field Action Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II FSCA FSCA FSCA FSCA MDA FSCA FSCA FSCA Class II Class II Class II Class II Class II
2009/02/12 2009/02/12 2009/02/12 2009/02/12 2009/02/12 2009/02/12 2009/02/12 2009/02/13 2009/02/13 2009/02/13 2009/02/13 2009/02/13 2009/02/13 2009/02/13 2009/02/13 2009/02/13 2009/02/13 2009/02/13 2009/02/13 2009/02/16 2009/02/16 2009/02/17 2009/02/18 2009/02/18 2009/02/18 2009/02/19 2009/02/19 2009/02/19 2009/02/19 2009/02/19
Stryker China Ltd N.A. N.A. N.A. N.A. N.A. BrainLAB Ltd Millipore Hong Kong Baxter Healthcare Ltd N.A. N.A. N.A. N.A. Uninet Technology LTD Medtronic International Ltd. Bio-Rad Pacific Ltd. Bio-Rad Pacific Ltd. N.A. N.A. BD N.A. Biomerieux China Ltd. (HK office) N.A. N.A. N.A. N.A. Stryker China Ltd Stryker China Ltd Stryker China Ltd GE Medical Systems Hong Kong Ltd.
2518 6915 N.A. N.A. N.A. N.A. N.A. 2417 1881 2803 9249 2807 8516 N.A. N.A. N.A. N.A. 2838 8423 2919 1362 N.A. N.A. N.A. N.A. 886-2722-5660 N.A. 2356 7033 N.A. N.A. N.A. N.A. 2518 6915 2518 6915 2518 6915 2783 1838
Medical Device Control Office
20
Department of Health The Government of HKSAR
SN090260 SN090261 SN090262 SN090263 SN090264 SN090265 SN090266 SN090267 SN090268 SN090269 SN090270 SN090271 SN090272 SN090273 SN090274 SN090275 SN090276 SN090277 SN090278 SN090279 SN090280 SN090281 SN090282 SN090283 SN090284 SN090285 SN090286 SN090287
Siemens Artiste MV Digital Linear Accelerator System equipped with 160 MCL Accessory Holder AGFA IMPAX Cardiovascular Polling Procedure version 1.00.09 Posey Connecting Straps and Belts/Locking Cuffs Advanced Bionics HR90K Platinum Series Headpiece; Platinum Series Headpiece ; S-Series Long Range Headpiece, S- Series Short Range Headpiece Synthes Nfix II System, N-Hance System, TI N-Hance Rod, Nflex Stabilization System Teleflex Medical CC IAB Catheters/Volume Connectors Maquet Heartstring II Proximal Seal System Blatchford Endolite 30mm Pyramid Adapt Siemens Sireskop SX and AXIOM Sireskop SD Tyco Shiley 3.0 Cuffless Paediatric Tracheostomy Johnson and Johnson (DePuy) Total knee replacement implant femoral components ­ PFC SIGMA Edwards Lifesciences Swan-Ganz Thermodilution Catheters Abbott RealTime HIV-1 Assay ConMed Endoscopic Disposable Polypectomy Snares and Gastrostomy Feeding Systems - EnTake PEG Varian Medical Systems Eclipse treatment planning system (Model no. H48, versions 6.5/7.x and Inspiration 8.0) Boston Scientific Atlantis PV Peripheral Imaging Catheter (Model no H749364560) Philips M8000-64100 Table Mount Siemens Drive Belt for Radiation Therapy Simulation Systems SIMVIEW 3000 and SIMVIEW NT with CT option or IDI Siemens MicroScan Synergies Plus Dried Overnight Gram Negative MIC/Combo Panels and MicroScan Synergies Plus Negative Panels Zoll Monitor portion of the LifeVest device (Model no. WCD3000 and WCD3100) Ossur 3" Titanium Skull Pin, 3" Ceramic Tip Pin,2 1/4" Ceramic Tip Pin Mako Surgical Femoral Array (Model no 0150ARR00001) and Tibial Array (Model no 0150ARR00002) Baxter System 1000 and Arena Haemodialysis instruments Edwards Lifesciences Fem-FlexII Paediatric Catheter GE Giraffe Warmer & Panda iRes Bio-Rad Laboratories Variant II Sytem with CDM 3.5 software, 3.6T System Boston Scientific Precision Spinal Cord stimulation system Bard Access Ponsky Non-Ballon Gastrostomy tube
FDA FDA FDA FDA FDA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA FDA FDA FDA FDA FDA FDA FDA FDA MHRA MHRA MHRA Health Canada Health Canada Health Canada
Z-0949-2009 Z-0945-2009 Z-0934-2009 Z-0956-2009 to Z-0959-2009 Z-0963-2009 to Z-0968-2009 2009/002/010/291/018 2009/002/013/051/002 2008/009/008/401/012 2009/002/013/051/003 2009/001/023/291/001 MDA/2009/016 2009/002/018/291/008 2009/002/019/291/015 2009/002/018/291/007 Z-0861-2009 Z-0837-2009 Z-0817-2009 Z-0646-2009 Z-0540-2009 to Z-0541-2009 Z-0883-2009 Z-0594-2009 to Z-0596-2009 Z-0915-2009 2009/002/010/291/017 2009/002/018/291/010 2009/001/021/601/001 46347 44523 42263
Class II Class II Class II Class II Class II FSCA FSCA FSCA FSCA FSCA MDA FSCA FSCA FSCA Class II Class II Class II Class II Class II Class II Class II Class II FSCA FSCA FSCA Type I Type II Type II
2009/02/19 2009/02/19 2009/02/19 2009/02/19 2009/02/19 2009/02/20 2009/02/23 2009/02/23 2009/02/23 2009/02/24 2009/02/25 2009/02/25 2009/02/25 2009/02/25 2009/02/26 2009/02/26 2009/02/26 2009/02/26 2009/02/26 2009/02/26 2009/02/26 2009/02/26 2009/02/27 2009/02/27 2009/02/27 2009/02/27 2009/02/27 2009/02/27
Siemens Healthcare Diagnostic Limited AGFA Hong Kong Limited N.A. N.A. Synthes (Hong Kong) Ltd N.A. Maquet Hong Kong LTD.
2810 7533 2555 9421 N.A. N.A. 2724 2032 N.A. 2393 9511
Siemens Healthcare Diagnostic Limited Tyco Healthcare (HKSAR) LTD Johnson & Johnson Medical (HK) N.A. Abbott Laboratories LTD. N.A. Varian Medical Systems Pacific Inc. Boston Scientific Hong Kong Ltd Philips Health Care (Great China) Siemens Healthcare Diagnostic Limited Siemens Healthcare Diagnostic Limited N.A. N.A. N.A. Baxter Healthcare Ltd N.A. GE Medical Systems Hong Kong Ltd. Bio-Rad Pacific Ltd. Boston Scientific Hong Kong Ltd N.A.
2810 7533 3157 7220 2738 6027 N.A. 2593 2211 N.A. 2724 2836 2960 7136 2821 5480 2810 7533 2810 7533 N.A. N.A. N.A. 2807 8516 N.A. 2783 1838 N.A. 2960 7136 N.A.
Medical Device Control Office
21
Department of Health The Government of HKSAR
SN090288
Fresenius Medical Patient On Line
Health Canada
41821
Type II
2009/02/27
Fresenius Medical Care Asia Pacific Ltd.
2802 2900
Medical Device Control Office
22
Department of Health The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - January 2009
Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada Date of Issue MDCO Ref. Source of Local Agent Description of Product Reference No. by Source Alert Type by Source (YYYY/MM/DD) No. Information SN090101 Terumo Advanced Perfusion System 1 (Model 801763 and 801764) Z-0445-2009 to Z-0446-2009 Class II 2009/01/02 TERUMO CHINA (H.K.) LTD. FDA CTS (Guidant Cardiac Surgery) VASOVIEW 4 Endoscopic Vessel SN090102 Z-0476-2009 Class II 2009/01/02 Boston Scientific Hong Kong Ltd FDA Harvesting System with VASOVIEW Flexible Endoscopic Tools FHC microTargeting Platform DBS Measuring Fixture (Cataog # 66Z-0486-2009 Class II 2009/01/02 N.A. SN090103 FDA FA-SF) Smiths Medical Wallace Oocyte Recovery Needles, Oocyte Z-0593-2009 Class II 2009/01/02 Gold Pacific Enterprises SN090104 FDA Recovery sets (Product no. ONS1633LL-750 and ONS1733LL-750) SN090105 SiemensIMMULITE/IMMULITE 1000 Progesterone (LKPG 1,5) Z-0524-2009 Class II 2009/01/02 Siemens Healthcare Diagnostic Limited FDA SN090106 Enterix Insure Quik Fit Developer Kit (Product no 30025 and 50025) Z-0480-2009 Class II 2009/01/02 N.A. FDA SN090107 Qualigen FastPack Total PSA Immunoassay (Catalog# 25000001) Z-0500-2009 Class II 2009/01/02 N.A. FDA Stryker Stair Chairs Stair-PRO 6251, Stair-PRO 6252, Evacuation SN090108 2008/011/028/061/020 FSCA 2009/01/07 Stryker China Ltd MHRA Chair Model 6253 SN090109 Johnson and Johnson ENDOPATH® Electrosurgery Probe Plus II 2008/012/009/061/007 FSCA 2009/01/07 Johnson & Johnson Medical (HK) MHRA SN090110 ArthroCare Saber 30 with Integrated Cable Wand 2008/012/009/061/003 FSCA 2009/01/08 N.A. MHRA EV3 Marathon Flow Directed Micro Catheter Catalog Number 105SN090111 2008/012/009/061/015 FSCA 2009/01/08 N.A. MHRA 5055 SN090112 GE Centricity Ultra Laboratory System Software Z-0472-2009 Class II 2009/01/08 GE Medical Systems Hong Kong Ltd. FDA SN090113 Siemens KinetDx 4.2 Workplace and syngo Dynamics Workplace Z-0543-2009 to Z-0545-2009 Class II 2009/01/08 Siemens Healthcare Diagnostic Limited FDA SN090114 Alphatec Spine Novel PEEK VBR XS Z-0507-2009 to Z-0508-2009 Class II 2009/01/08 N.A. FDA SN090115 Cordis MassTRANSIT Infusion Catheter Kit, 605-731K & 605-780K Z-0604-2009 Class II 2009/01/08 N.A. FDA SN090116 Stryker Leibinger New Generation/Universal Mandibular System Z-0610-2009 Class II 2009/01/08 Stryker China Ltd FDA SN090117 Sunrise Medical DeVilbiss Model 515A Oxygen Concentrator Z-0617-2009 Class II 2009/01/08 N.A. FDA CovaTec Flexi-Seal Fecal Management System Advanced Odor SN090118 Z-0618-2008 Class II 2009/01/08 N.A. FDA Control Kit. Rx only SN090119 Edwards Lifesciences EndoClamp aortic catheter Z-0644-2009 to Z-0645-2009 Class II 2009/01/08 N.A. FDA SN090120 Hyphen BioMed Biophen Heparin 6 (various lots) 2008/012/003/061/001 FSCA 2009/01/09 N.A. MHRA SN090121 Siemens ADVIA Centaur HIV 1/O/2 Enhanced (EHIV) Assay 2008/012/023/051/001 FSCA 2009/01/09 Siemens Healthcare Diagnostic Limited MHRA SN090122 Arcomedical Infusion Syramed SP6000 Syringe Pumps 2008/011/005/601/004 FSCA 2009/01/09 N.A. MHRA Boston Scientific SN090123 Boston Scientific Safety and Standard Push PEG Kits N.A. Firm Initiated Field Action 2009/01/13 Boston Scientific Hong Kong Ltd Hong Kong Ltd Zimmer NexGen® Complete Knee Solution Provisional Articular SN090124 2008/012/016/061/007 FSCA 2009/01/14 Zimmer PTE Ltd. (Hong Kong branch) MHRA Surface SN090125 ThermoFisher BO0366G Brain heart infusion, lot number 1070312 2008/012/015/601/005 FSCA 2009/01/14 N.A. MHRA GE OEC 9900 Elite ESP Fluoroscopic x-Ray System and GSP SN090126 Z-0341-2009 to Z-0342-2009 Class II 2009/01/14 GE Medical Systems Hong Kong Ltd. FDA Fluoroscopic x-Ray System Rockwell Medical SteriLyte Liquid Bicarbinate, Formula CL-02 and SN090127 Z-0439-2009 to Z-0440-2009 Class II 2009/01/14 N.A. FDA RL 01 SN090128 Innovative Implant Sinu-Lift System (Model SLS-1) Z-0505-2009 Class II 2009/01/14 N.A. FDA SN090129 Biomet Compress Instrument Anchor Plug Holders Z-0517-2009 to Z-0521-2009 Class II 2009/01/14 N.A. FDA Hill-Rom Synergy Pulse, Synergy Dynamic, Synergy Air Squared SN090130 Z-0600-2009 to Z-0603-2009 Class II 2009/01/14 N.A. FDA and Pro 2000 Roche Diagnostics ISE Internal Standard Gen 2 (Catalog no Z-0542-2009 Class II 2009/01/14 Roche Diagnostics (Hong Kong) Ltd SN090131 FDA 04522320190) SN090132 GE Solar 8000M System Z-0285-2009 Class II 2009/01/14 GE Medical Systems Hong Kong Ltd. FDA SN090133 Siemens CT syngo Dual Energy Viewer (Model 10094833) Z-0647-2009 Class II 2009/01/14 Siemens Healthcare Diagnostic Limited FDA SN090134 Hitachi CXR4 Computed Tomography Scanner Z-0608-2009 Class II 2009/01/14 N.A. FDA ACIST CVi Angiographic Injection System (Model: CVi Toshiba SN090135 Z-0643-2009 Class II 2009/01/14 N.A. FDA interface Cable) SN090136 Diamedix Measles IgG Enzyme Immunoassay Test Kit (DIAMEDIX) Z-0607-2009 Class II 2009/01/14 N.A. FDA Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate SN090137 Z-0871-2009 Class II 2009/01/14 Zimmer PTE Ltd. (Hong Kong branch) FDA (Ref 6420-01-230) SN090138 Frontier Medical Repose Mattress and Cushion 2008/009/015/301/001 FSCA 2009/01/15 N.A. MHRA Agent Contact Telephone No 2866 0811 2960 7136 N.A. 2544 2602 2810 7533 N.A. N.A. 2518 6915 2738 6027 N.A. N.A. 2783 1838 2810 7533 N.A. N.A. 2518 6915 N.A. N.A. N.A. N.A. 2810 7533 N.A. 2960 7136 2992 0968 N.A. 2783 1838 N.A. N.A. N.A. N.A. 2485 7510 2783 1838 2810 7533 N.A. N.A. N.A. 2992 0968 N.A.
Medical Device Control Office
23
Department of Health The Government of HKSAR
SN090139 SN090140 SN090141 SN090142 SN090143 SN090144 SN090145 SN090146 SN090147 SN090148 SN090149 SN090150 SN090151 SN090152 SN090153 SN090154 SN090155 SN090156 SN090157 SN090158 SN090159 SN090160 SN090161 SN090162 SN090163 SN090164 SN090165 SN090166 SN090167 SN090168 SN090169 SN090170 SN090171 SN090172 SN090173 SN090174 SN090175 SN090176 SN090177 SN090178 SN090179 SN090180 SN090181 SN090182
Boston Scientific Stonetome Single-Use Stone Removal Device Stryker Intouch Bed Model 2130 with positionpro (model: 2130-000000), Intouch Bed Model 2140 with Positionpro (model: 2140-000Biomet Microfixation A) Lactosorb Endobrow Lift Complete, B) Office Fixation Kit, C) 1.5/IMF Small Office Set Toshiba Aquilion One (TSX-310A/2) Invacare Careguard Mattress Medtronic DLP Pericardial / Intracardiac Sump Philips Easydiagnost Eleva Convatec Flexi-Seal FMS Advanced Odor Control KCI Kinair IV Maquet Maquet Foot Paddle Philips Multi Diagnostic Eleva-Flat Detector-IM Stryker Patient Registration Mask (Box of 5) Coloplast Philips Bougle Roche Diagnostics Process System Manager Smith & Nephew Reflection Hip PE Inlay (7174-0250) Synthes (Canada) Synfix LR, Low Profile U-Joint Driver KCI Therapulse ATP Biomerieux Vitek 2 GN Card Abbott Voyager RX Coronary Dilation Catheter (1011759-08, 1011759-12) Philips A) Allura XER FD10/10, B) Allura XPER FD20/10 System, C) Integris H5000C Cardiology Imaging System (722016), D) Integris Allura (722043), E) Allura XPER FD10, F) Allura XPER FD20 Philips A) Allura XPER FD20/10 System, B) Integris H5000C Cardiology Imaging System (722016), C) Integris Allura (722043), D) Allura XPER FD10, E) Allura XPER FD20 System Stryker A)Intouch Critical Care Bed Model 2130 (2130-000-000), B) Intouch critical Care Bed Model 2140 (2140-000-000) St Jude Medical Epicor LP Connecting Cable BioMerieux Vironostika HIV Uni-Form II Ag/Ab Owen MumfordAutopen Classic 3ml, 1 unit (1-21 units) Siemens ADVlA Centaur, Centaur CP and Centaur XP, iPTH assay Biomet Sterile 1/3 Tubular Plates (85 mm x 7 Holes) ThermoFisher BO0351E, Tryptone soya broth, lot number 1045903 Ortho Solutions FPS Locking Screws (14mm/18ms) ThermoFisher TPHA Test Kit BioMerieux Chocolate PolyViteX VCAT3 agar Diagnostica Stago STA - Cuvettes Abbott CELL-DYN Sapphire Haemoglobin Reagent Syringe 08H4902 Smiths Medical BCI 9200 Advisor Vital Signs Monitor CMS Software 4.3.1 through 4.40.00 Sorin Mini Bypass Bag Days Healthcare Walking frame Olympus PK7300 blood grouping system Siemens Sentinel Apolipoprotein B Otto Bock Blizzard Active Wheelchair Bausch & Lomb Akreos Advanced Optics Aspheric Lens Maquet SERVO 300A Automode Philips Pulmonary Toolkit Medtronic MicroTargetingTM Drive System and Accessories
Boston Scientific Hong Kong Ltd Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada
N.A. 45354 43740 44879 45093 45468 45433 45051 45500 44983 44908 45115 45314 44820 45263 45120 44999 44650 44757 44817 45310 45351 2008/012/010/061/001 2008/011/019/061/001 2008/010/002/401/007 2008/012/001/061/004 2008/012/002/291/002 2008/012/015/601/004 2008/010/017/401/001 2008/012/022/051/001 2008/012/001/601/001 2008/012/030/291/017 2008/012/022/601/003 2008/012/030/061/006 2008/012/012/601/004 2008/012/031/061/002 2008/010/007/401/016 2008/012/023/051/002 2009/001/005/061/005 2008/012/029/301/002 2008/012/019/291/002 2008/012/016/061/001 2008/012/029/291/001 2008/012/030/291/011
Firm Initiated Field Action Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA
2009/01/15 2009/01/15 2009/01/15 2009/01/15 2009/01/15 2009/01/15 2009/01/15 2009/01/15 2009/01/15 2009/01/15 2009/01/15 2009/01/15 2009/01/15 2009/01/15 2009/01/15 2009/01/15 2009/01/15 2009/01/15 2009/01/15 2009/01/15 2009/01/15 2009/01/15 2009/01/20 2009/01/20 2009/01/20 2009/01/20 2009/01/20 2009/01/20 2009/01/20 2009/01/20 2009/01/21 2009/01/21 2009/01/21 2009/01/21 2009/01/21 2009/01/21 2009/01/21 2009/01/21 2009/01/21 2009/01/21 2009/01/21 2009/01/21 2009/01/22 2009/01/22
Boston Scientific Hong Kong Ltd Stryker China Ltd N.A. Sanko Medical Systems (HK) LTD Direct Health LTD Medtronic International, Ltd. Philips Health Care (Great China) Bristol-Myers Squibb (HK) LTD. N.A. Maquet Hong Kong LTD. Philips Health Care (Great China) Stryker China Ltd Coloplast (HK) LTD Roche Diagnostics (Hong Kong) Ltd Smith & Nephew LTD Synthes International Ltd. N.A. Biomerieux China Ltd. (HK office) Abbott Laboratories LTD. Philips Health Care (Great China) Philips Health Care (Great China) Stryker China Ltd N.A. Biomerieux China Ltd. (HK office) N.A. Siemens Healthcare Diagnostic Limited Goodman Medical Supplies Ltd N.A. N.A. N.A. Biomerieux China Ltd. (HK office) Healthpro Technology Co. Ltd Abbott Laboratories LTD. Goodman Medical Supplies Ltd N.A. N.A. N.A. Olympus Hong Kong and China Limited Siemens Healthcare Diagnostic Limited N.A. Bausch & Lomb (Hong Kong ) Ltd Maquet Hong Kong LTD. Philips Health Care (Great China) Medtronic International, Ltd.
2960 7136 2518 6915 N.A. 238400688 N.A. 2919 1300 2821 5480 2510 6146 N.A. 2393 9511 2821 5480 2518 6915 3628 7427 2485 7510 2648 7700 N.A. N.A. 2356 7033 2593 2211 2821 5480 2821 5480 2518 6915 N.A. 2356 7033 N.A. 2810 7533 2332 4455 N.A. N.A. N.A. 2356 7033 N.A. 2593 2211 2332 4455 N.A. N.A. N.A. 2170 5603 2810 7533 N.A. 2213 3371 2393 9511 2821 5480 2919 1300
Health Canada Health Canada MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA
Medical Device Control Office
24
Department of Health The Government of HKSAR
SN090183 SN090184 SN090185 SN090186 SN090187 SN090188 SN090189 SN090190 SN090191 SN090192 SN090193 SN090194 SN090195 SN090196 SN090197 SN090198 SN090199 SN0101100 SN0101101 SN0101102 SN0101103 SN0101104 SN0101105 SN0101106 SN0101107 SN0101108 SN0101109 SN0101110 SN0101111 SN0101112 SN0101113 SN0101114 SN0101115 SN0101116 SN0101117 SN0101118 SN0101119 SN0101120 SN0101121 SN0101122 SN0101123 SN0101124 SN0101125
Baxter System 1000 Series of Hemodialysis Instruments with 4.D.0.3 or 4.D.0.4 Software Kivi Uniloc wheelchair docking system AKE 04 Varian Medical Systems Eclipse 8.5 (build 8.2.2X) systems with distributed Calculation Framework (DCF) 8.2.22 (Model no H48) GE Centricity Enterprise Web 3.0 software Stryker Triathlon PKR Insert X3#1 LM/RL-8mm (Catalog no.: 5630G-108) and Triathlon PKR Insert X3#1 RM/LL -12mm (Catalog no: Siemens Ariste MV Digital Linear Accelerator Dade Behring (a Siemens Company) Dimension EXL Clinical Chemistry System Abbott Clinical Chemistry Bilirubin Calibrator Depuy (Johnson and Johnson) DELTA Xtend, Standard Humeral PE Cup Beckman Coulter Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.2 (Part no 626553) Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block Accuray RoboCouch Patient Support System (Model No 025007) VIBE Quantum Pulse machine Sterilmed various products Nutricia Enteral feeding pump Schulke & Mayr Mikrozid sensitive wipes Cardinal Health Alaris GP LVP (Model 80063UN01), Alaris GP Guardrails Volumetric Pump (Model 80263UN01-G) Proact Medical Green System Duo Laryngoscope Handle GE OEC 7600 and OEC 7700 Elekta Leksell GainmaPlan / Leksell SurgiPlan Stryker HA Hip Stems: ABG II, Omnifit C-Taper, Accolade Roche Hitachi 917 Modular Analytics ThermoFisher Lactose peptone water with Durham s tube BO0435B Joint Replacement Instrumentation BiPolar Head A2U Nano supportive seating system Advanced Healthcare Technology Babypod II, Evo2 and Evo3 Siemens Somatom Definition AS Siemens syngo Workflow MLR Stryker Pneumo Sure XL High Flow Insufflator Gen-Probe ACCUPROBE Group B Streptococcus kit, ACCUPROBE M. tuberculosis Complex, ACCUPROBE M. avium Complex Croma-Pharma Quatrix Acrylic Intraocular lenses with a preloaded injector ThermoFisher Oxoid Staphytect Plus Dry Spot Kit Invacare Action® 2000 Manual Wheelchair Philips PCR Eleva Coloplast Philips Catheter, 1Eye, Female Metric Thread (Catalogue no. AG55) Bausch & Lomb High Speed Vitrectomy cutter product (CX4804) Stryker Endoscopy FloControl Arthroscopy Pump Integrated Tubing (Model no 0350600006) Stryker Vision 3 Flat Panel Shroud (Part#0682-000-414, 0682-000415 and 0682-000-416) Stryker Dri-Lok Disposable Cannula Philips Vertical drive brake on patient supports Philips NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software) Accuray CyberKnife Robotic Radiosurgery System GE Innova 2100IQ, 3100/3100IQ, 4100/4100IQ
MHRA MHRA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA Coloplast (HK) Ltd Bausch & Lomb FDA FDA FDA FDA FDA FDA FDA
2009/001/013/291/003 2009/001/012/301/001 N.A. Z-0870-2009 Z-0869-2009 Z-0857-2009 Z-0581-2009 Z-0580-2009 Z-0532-2009 to Z-0539-2009 Z-0129-2009 Z-0873-2009 to Z-0882-2009 Z-0856-2009 Z-0582-2009 Z-0546-2009 to Z-0577-2009 MDA/2009/004 2008/011/019/061/022 2009/001/005/061/007 2008/010/024/401/007 2009/001/009/061/002 2008/012/017/061/006 2009/001/007/061/008 2008/011/026/291/009 2009/001/012/601/001 2009/001/008/061/005 2008/012/023/401/006 2008/012/012/401/010 2008/012/012/291/003 2008/012/022/051/003 2009/001/016/291/004 2009/001/014/601/004 2009/001/012/291/017 2008/010/017/061/003 2008/010/020/401/012 2009/001/021/291/004 N.A. N.A. Z-0652-2009 Z-0625-2009 Z-0868-2009 Z-0597-2009 Z-0001-2009 Z-0629-2009 Z-0473-2009 to Z-0475-2009
FSCA FSCA Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II MDA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA Firm Initiated Field Action Firm Initiated Field Action Class II Class II Class II Class II Class II Class II Class II
2009/01/22 2009/01/22 2009/01/22 2009/01/22 2009/01/22 2009/01/22 2009/01/22 2009/01/22 2009/01/22 2009/01/22 2009/01/22 2009/01/22 2009/01/22 2009/01/22 2009/01/23 2009/01/23 2009/01/23 2009/01/23 2009/01/29 2009/01/29 2009/01/29 2009/01/29 2009/01/29 2009/01/29 2009/01/29 2009/01/29 2009/01/29 2009/01/29 2009/01/29 2009/01/29 2009/01/29 2009/01/29 2009/01/29 2009/01/29 2009/01/30 2009/01/30 2009/01/30 2009/01/30 2009/01/30 2009/01/30 2009/01/30 2009/01/30 2009/01/30
Baxter Healthcare Ltd N.A. Varian Medical Systems Pacific Inc. GE Medical Systems Hong Kong Ltd. Stryker China Ltd Siemens Healthcare Diagnostic Limited Siemens Healthcare Diagnostic Limited Abbott Laboratories LTD. Johnson & Johnson Medical (HK) Beckman Coulter Hong Kong Ltd N.A. Accuray Asia Ltd N.A. N.A. N.A. N.A. N.A. N.A. GE Medical Systems Hong Kong Ltd. N.A. Stryker China Ltd Roche Diagnostics (Hong Kong) Ltd N.A. N.A. N.A. N.A. Siemens Healthcare Diagnostic Limited Siemens Healthcare Diagnostic Limited Stryker China Ltd N.A. N.A. N.A. N.A. Philips Health Care (Great China) Coloplast (HK) LTD Bausch & Lomb (Hong Kong ) Ltd Stryker China Ltd Stryker China Ltd Stryker China Ltd Philips Health Care (Great China) Philips Health Care (Great China) Accuray Asia Ltd GE Medical Systems Hong Kong Ltd.
2807 8516 N.A. 2724 2836 2783 1838 2518 6915 2810 7533 2810 7533 2593 2211 2738 6027 2240 6150 N.A. 2247 8628 N.A. N.A. N.A. N.A. N.A. N.A. 2783 1838 N.A. 2518 6915 2485 7510 N.A. N.A. N.A. N.A. 2810 7533 2810 7533 2518 6915 N.A. N.A. N.A. N.A. 2821 5480 3628 7428 2213 3371 2518 6915 2518 6915 2518 6915 2821 5480 2821 5480 2247 8628 2783 1838
Medical Device Control Office
25
Department of Health The Government of HKSAR
SN0101126 SN0101127 SN0101128 SN0101129 SN0101130 SN0101131 SN0101132 SN0101133 SN0101134 SN0101135 SN0101136 SN0101137 SN0101138 SN0101139 SN0101140 SN0101141 SN0101142
Cardinal Health Esmark Elastic Bandage INGfertility Pre Isotonic Personal Lubricant labeled PRE Patient Lubricant Alimed Gait Belt (Transfer Aid) (Model 72108, 72109) Quantimetrix QuanTscopics Urine Microscopics Contro Hill- Rom 70 Semi-Electric Bed (Model HS-968) Ansell Healthcare Products Conform XT - Gloves (Model: 69318) Ossur HF ReSolve Open Back Halo Ring Maquet Reservoirs (BEQ-VHK 2001) Styker Dri-Lok Disposable Cannulas BHM Medical Ergolift, Ergolift-2 Roche Diagnostics Process System Manager (Model: 3009696001) Baxter Colleague Volumetric Infusion Pump (Model: 2M8151K) Harvest Technologies Autologous Platelet Concentrate System (Model: APC-201) Philips A) Multidiagnost Eleva - Image Intensifier (70832), B) Multidiagnost Eleva - Flat Detector (70834), C) Omnidiagnost Eleva White Peaks Dental Systems Origin YZ Zirconia Blocks, Origin YZ Zirconia Disc MC Healthcare Products QP2508 Hand Pendant (Model: HB43U010-00/01 Smiths Medical Medfusion Syringe Pump (Model: 3500-306, 3500415)
FDA FDA FDA FDA FDA Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada
Z-0615-2009 to Z-0616-2009 Z-0626-2009 Z-0598-2009 Z-0513-2009 to Z-0516-2009 Z-0506-2009 45563 45100 45565 45616 45626 45358 41402 45706 45311 44705 45786 45802
Class II Class II Class II Class II Class II Type II Type II Type II Type II Type I Type I Type II Type II Type II Type II Type II Type II
2009/01/30 2009/01/30 2009/01/30 2009/01/30 2009/01/30 2009/01/30 2009/01/30 2009/01/30 2009/01/30 2009/01/30 2009/01/30 2009/01/30 2009/01/30 2009/01/30 2009/01/30 2009/01/30 2009/01/30
N.A. N.A. N.A. N.A. N.A. N.A. N.A. Maquet Hong Kong LTD. Stryker China Ltd Arjo Huntleigh (Hong Kong) Ltd. Roche Diagnostics (Hong Kong) Ltd Baxter Healthcare Ltd N.A. Philips Health Care (Great China) N.A. N.A. N.A.
N.A. N.A. N.A. N.A. N.A. N.A. N.A. 2393 9511 2518 6915 2508 1416 2485 7510 2807 8516 N.A. 2821 5480 N.A. N.A. N.A.
Medical Device Control Office
26
Department of Health The Government of HKSAR
Device Safety Alerts - December 2008
s and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. Description of Product No. SN081201 SN081202 SN081203 SN081204 SN081205 SN081206 SN081207 SN081208 SN081209 SN081210 SN081211 SN081212 SN081213 SN081214 SN081215 SN081216 SN081217 SN081218 SN081219 SN081220 SN081221 SN081222 SN081223 Autoadapt DriveLOC and Carosafe II Liko LikoScale 200 Diamed ID DiaScreen Prophylax ThermoFisher Staphaurex Plus Philips Omni, Multi and Easy Diagnost Systems using GCF Velara Generator with Tube Grid switch Zimmer Silhouette Axial Torque Wrench Edwards Lifesciences Aquarius software operating manuals Siemens Syngo Dynamics version 4.2, 5.x, 6.0 Integra LifeSciences Uni-CP Compression Forceps (Spreader) (Catalog no 339001ND) Boston Scientific RF Ablation System Foot Switch Boston Scientific Flextome Cutting Balloon w/Over-the-Wire Delivery System Johnson and Johnson ENDOPATH Electrosurgery Probe Plus II Medtronic EnTrust® Implantable Cardioverter Defibrillators Otto Bock Healthcare 3R66 ­ Modular Polycentric Knee Joint Varian Linear accelerators other than Clinac GE Healthcare CT/e and HiSpeed X/I families of Computed Tomography systems Baxter COLLEAGUE Triple Channel Mono, and CXE Volumetric Infusion Pumps 2M8153K and 2M9163 AMO Healon D Ophthalmic Viscosurgical Device (Lot No. UD30654) Integra NeuroSciences Gravity Compensating Accessory Posey Synthetic Leather and Biothane Waist and Wrist Restraints (Catalog No 2217SL and 2217B) Siemens AXIOM Artis System Siemens syngo MultiModality WorkPlace (MM WP), software product (Model No 10140720) Terumo Sarns Sternal Saw II System Power Unit Source of Information MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA FDA Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd Johnson & Johnson Medical (HK) MHRA MHRA Varian Medical Systems Pacific Inc. GE Medical Systems Hong Kong Ltd. MHRA FDA FDA FDA FDA FDA FDA Reference No. by Source 2008/003/006/301/002 2008/005/029/401/009 2008/011/021/061/012 2008/011/024/601/002 2008/011/021/291/003 2008/011/021/061/010 2008/011/024/291/007 2008/009/008/061/001 Z-0307-2009 N/A N/A N/A 2008/011/021/061/005 2008/011/006/301/001 N/A N/A 2008/011/028/061/015 Z-0343-2009 Z-0458-2009 Z-0286-2009 Z-0312-2009 to Z-0317-2009 Z-0324-2009 Z-0358-2009 to Z-0359-2009 Alert Type by Source FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA Class II Firm Initiated Field Action Firm Initiated Field Action Firm Initiated Field Action FSCA FSCA Firm Initiated Field Action Firm Initiated Field Action FSCA Class I Class I Class II Class II Class II Class II Date of Issue (YYYY/MM/DD) 01-Dec-08 01-Dec-08 01-Dec-08 01-Dec-08 01-Dec-08 01-Dec-08 01-Dec-08 02-Dec-08 04-Dec-08 05-Dec-08 05-Dec-08 05-Dec-08 08-Dec-08 08-Dec-08 10-Dec-08 10-Dec-08 15-Dec-08 15-Dec-08 15-Dec-08 15-Dec-08 15-Dec-08 15-Dec-08 15-Dec-08 Local Agent N/A N/A DIAMED-CHINA LTD. N/A Philips Healthcare - Great China Zimmer PTE Ltd. (Hong Kong branch) N/A Siemens Healthcare Diagnostic Limited N/A Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd Johnson & Johnson Medical (HK) Medtronic International, Ltd. N/A Varian Medical Systems Pacific Inc. GE Medical Systems Hong Kong Ltd. Baxter Healthcare Ltd AMO Asia Limited N/A N/A Siemens Healthcare Diagnostic Limited Siemens Healthcare Diagnostic Limited TERUMO CHINA (H.K.) LTD. Agent Contact Telephone No N/A N/A 251 262 38 N/A 2821 5480 2992 0968 N/A 2810 7533 N/A 2960 7136 2960 7136 2738 6027 2907 5911 N/A 2722 8123 2783 1888 2807 8555 2480 3330 N/A N/A 2810 7533 2810 7533 2529 0451
Medical Device Control Office
27
Department of Health The Government of HKSAR
SN081224 SN081225 SN081226 SN081227 SN081228 SN081229 SN081230 SN081231 SN081232 SN081233 SN081234 SN081235 SN081236 SN081237 SN081238 SN081239 SN081240 SN081241 SN081242 SN081243 SN081244 SN081245 SN081246 SN081247 SN081248 SN081249 SN081250
Medtronic 5F, 6F, 7F BardSelect 1cm Percutaneous Catheter Introducer Set Johnson and Johnson STERRAD NX Sterilizer (Product Code 10033) Radiometer Calibrator 1 Solution for the ABL700 Series Cardinal Health GSI Audera (version 2.6 Software) System Stryker Pain Pump 2 Blockaid (0575-100-000) Smiths Medical Disposable Norothermic IV Admin. Sets (DI-100, DI50) Oxoid Filteredhorse Serum (SR0035C) BHM Battery Model NDA 0200-20 Technidata TD-Synergy Software (TD-SYS-01) Orasure Intercept Mirco-Plate EIA Kit (Model: 61452, 61454, 61456) Hill-Rom Liko Uno 100, 101, 102 Patient Lift InteleViewer module of the Intel PACS and Intele Viewer Workstation (V3-X-X) Philips EGM Essential Gas Module (GI M1013A, G5 M1019A), Intellivue Patient Monitoring Sys. (M8002A, M8004A, M8007A), Intellivue Patient Monitor (M8105A M8105AT) Clinical Instruments Carotid Shunt Outlying / Inlying with T-Port Beckman Coulter UniCel Dxl Access Immunoassay Systems Wash Buffer II Lots 70662 and 70637 Siemens CT Syngo Dual Energy Viewer Fresenius Medical Care 5008 dialysis machine Smiths Medical Deltec Cozmo Insulin Pump Model number 1800 Terumo Sarns Level Sensor II Pads (Ref 195240) Terumo Advanced Perfusion System 1 (Model no.: 801040, 801041, 816570, 816571) GE Centricity PACS RA1000 Workstation Siemens Dade Behring Dimension Enzymatic Creatinine Flex reagent cartridge, DF270 Fisher & Paykel Healthcare RT240 Adult Breathing Circuit Kit Acumed Modular Shoulder Body Assembly Promega RNAgents Total RNA Isolation System (Cat. #Z5110) Medtronic LIFEPAK®9, LIFEPAK 9P, LIFEPAK 12, LIFEPAK 20/20e External Sterilizable Paddles and Pediatric Paddles Sun Med Greenline/D Maclntosh No. 3 Laryngoscope Blades
FDA FDA FDA FDA Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada MHRA MHRA MHRA MHRA FDA FDA FDA FDA FDA FDA FDA MHRA FDA
Z-0441-2009 to Z-0444-2009 Z-0484-2009 Z-0457-2009 Z-0195-2009 44921 44870 44449 45060 44744 44505 44701 44646 44525 44867 2008/011/027/601/001 2008/010/031/061/006 2008/012/001/061/001 2008/011/027/061/013 Z-0311-2009 Z-0354-2009 to Z-0357-2009 Z-0460-2009 Z-0485-2009 Z-0414-2009 Z-0477-2009 Z-0483-2009 2008/011/024/291/001 N/A
Class II Class II Class II Class II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II FSCA FSCA FSCA FSCA Class II Class II Class II Class II Class II Class II Class II FSCA Class I
15-Dec-08 15-Dec-08 15-Dec-08 15-Dec-08 17-Dec-08 17-Dec-08 17-Dec-08 17-Dec-08 17-Dec-08 17-Dec-08 17-Dec-08 17-Dec-08 17-Dec-08 17-Dec-08 17-Dec-08 17-Dec-08 17-Dec-08 17-Dec-08 18-Dec-08 18-Dec-08 18-Dec-08 18-Dec-08 18-Dec-08 18-Dec-08 18-Dec-08 19-Dec-08 22-Dec-08
Medtronic International, Ltd. Johnson & Johnson Medical (HK) N/A N/A Stryker China Ltd Smiths Medical (S.E. Asia) Ltd. South East Chemical & Instrument Ltd BHM Medical Inc. N/A N/A N/A N/A Philips Healthcare - Great China N/A Beckman Coulter Hong Kong Ltd Siemens Healthcare Diagnostic Limited N/A Smiths Medical (S.E. Asia) Ltd. TERUMO CHINA (H.K.) LTD. TERUMO CHINA (H.K.) LTD. GE Medical Systems Hong Kong Ltd. Siemens Healthcare Diagnostic Limited N/A N/A Bio-Gene Technology Ltd Medtronic International, Ltd. N/A
2907 5911 2738 6027 N/A N/A 2518 6988 2317 0988 28026333 N/A N/A N/A N/A N/A 2821 5480 N/A 2240 6150 2810 7533 N/A 2317 0988 2866 0811 2866 0811 2783 1888 2810 7533 N/A N/A 2646 6101 2907 5911 N/A
Medical Device Control Office
28
Department of Health The Government of HKSAR
SN081251 SN081252 SN081253 SN081254 SN081255 SN081256 SN081257 SN081258 SN081259 SN081260 SN081261 SN081262 SN081263 SN081264 SN081265 SN081266
Bard feeding kits (containing ConMed grasping snares) Medtronic Reveal DX Insertable Cardiac Monitor (ICM) Joerns Healthcare Oxford disposable slings Stryker Custom Cranial Implant Kits Boston Scientific iLab Ultrasound Imaging System, models 120INS and 240INS Arjo Maxi 500 Patient Lift with 2-Point Spreader Bar and Scale, Manual 4-Point DPS and scale Beckman Coulter Vidiera NsP Nucleic Sample Preparation Alfa Wassermann ACE and ACE Alera Hemoglobin A1C FHC MicroTargeting Electrode Arjo Maxi Move, Model NDA0200-20 Batteries Pack Bk Medical Single-use sterile puncture attachment UA1256-U Boston Scientific Convoy Advanced Delivery Sheath Kits Boston Scientific Gold Probe Single-Use Bi-Polar Electrohemostasis Catheters Wescott Medical Sae-Flo MD Extension Set with Y-Connector Siemens Leonardo Workstation Biotronik EDP 30/A
Bard Pacific Health Care Co Ltd Medtronic International Ltd MHRA FDA FDA FDA FDA FDA FDA FDA FDA Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd MHRA MHRA MHRA
N/A N/A MDA/2008/088 N/A Z-0338-2009 Z-0412-2009 to Z-0413-2009 Z-0454-2009 Z-0482-2009 Z-0497-2009 to Z-0498-2009 Z-0503-2009 Z-0504-2009 N/A N/A 2008/010/022/601/001 2008/004/010/061/006 2007/002/007/401/009
Firm Initiated Field Action Firm Initiated Field Action MDA Class I Class II Class II Class II Class II Class II Class II Class II Firm Initiated Field Action Firm Initiated Field Action FSCA FSCA FSCA
22-Dec-08 23-Dec-08 23-Dec-08 29-Dec-08 30-Dec-08 30-Dec-08 30-Dec-08 30-Dec-08 30-Dec-08 30-Dec-08 30-Dec-08 30-Dec-08 30-Dec-08 31-Dec-08 31-Dec-08 31-Dec-08
Bard Pacific Health Care Co Ltd Medtronic International, Ltd. N/A Stryker China Ltd Boston Scientific Hong Kong Ltd Arjo Huntleigh (Hong Kong) Ltd Beckman Coulter Hong Kong Ltd N/A N/A Arjo Huntleigh (Hong Kong) Ltd N/A Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd N/A Siemens Healthcare Diagnostic Limited N/A
886-2-2503-1900 2907 5911 N/A 2518 6988 2960 7136 2508 9553 2240 6150 N/A N/A 2508 9553 N/A 2960 7136 2960 7136 N/A 2810 7533 N/A
Medical Device Control Office
29
Department of Health The Government of HKSAR
Device Safety Alerts - November 2008
Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. Description of Product No. SN081101 vibe Technologies, Vibrational Integrated Biophotonic Energizer (VIBE) Machine Multi-Frequency Field Generator Beckman Coulter UniCel® DxI® 800 and UniCel DxI 600 Access® Immunoassay Systems and UniCel DxC 880i SYNCHRON® Access Clinical System Smiths Medical Wallace Oocyte Recovery Needle Pride Jazzy 1121 power chairs TomoTherapy Hi-Art System Teleflex Medical Great Ormond Street Tracheostomy Cannula Set Cardiac Science Powerheart AEDs TerumoTenderflow Pediatric Arterial Cannula Biomet Various AGC /5+ Reamer /Hiploc Instrument cases Biomet EZloc Femoral Fixation 9-10mm Standard Length -- 904781 Abbott Voyager NC Coronary Dilatation Catheter (4.5mm diameter) Tyco Healthcare (Covidien) ReliOn Insulin Syringes Medtronic DBS" 3387S-40 Lead Kit for Deep Brain Stimulation B Braun Smallbore T-Port Extension Set (Item no 474515) ( Siemens Axiom Aristos FX Multipurpose Radiography System (Model no 7414803) Siemens Acuson/Sonovista X300 Ultrasound systems (Software version 2.0.1 - 2.0.05, 3.0.01 and 3.0.02 Siemens Coherence Therapist Systems Siemens Syngo Imaging with versions VB20B, VB20D, VB20G, VB25B,VB30A, VB30A-SP1 and VB30A-SP2 (Model no 10014063) Siemens Acuson X300 Ultrasound Systems (Model no. 10037409, 10038837, 10348531, 10132987, 10133170, 10348532, 10348533) Siemens Artiste MV System (Part no 8139789) Stryker Osteosynthesis Reduction Spoon (Product Code 1806-0125) Stryker Ray TFC Device with End Caps Source of Information FDA Reference No. by Source N/A Alert Type by Source Class I Date of Issue (YYYY/MM/DD) 2009/11/03 Local Agent N/A Agent Contact Telephone No N/A
SN081102 SN081103 SN081104 SN081105 SN081106 SN081107 SN081108 SN081109 SN081110 SN081111 SN081112 SN081113 SN081114 SN081115 SN081116 SN081117 SN081118 SN081119 SN081120 SN081121 SN081122
MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA Abbott Laboratories Ltd FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA
2008/010/027/601/002 2008/010/022/061/011 2008/004/024/401/003 2008/010/014/061/018 2008/006/018/061/013 2008/002/011/061/010 2008/010/028/061/006 2008/010/027/601/003 2008/010/014/601/004 N/A N/A Z-0184-2009 to Z-0187-2009 Z-0199-2009 Z-0163-2009 Z-0086-2009 Z-0089-2009 to Z-0099-2009 Z-0102-2009 Z-0111-2009 Z-0116-2009 Z-0191-2009 Z-0151-2009
FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA Firm Initiated Field Action Press Release Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II
2008/11/03 2008/11/03 2008/11/03 2008/11/03 2008/11/03 2008/11/03 2008/11/03 2008/11/03 2008/11/03 2008/11/05 2008/11/06 2008/11/07 2008/11/07 2008/11/07 2008/11/07 2008/11/07 2008/11/07 2008/11/07 2008/11/07 2008/11/07 2008/11/07
Beckman Coulter Hong Kong Ltd N/A N/A N/A N/A N/A N/A N/A N/A Abbott Laboratories Ltd. Tyco Healthcare (HKSAR) LTD Medtronic International, Ltd. B Braun Medical Hong Kong Siemens Healthcare Diagnostic Limited Siemens Healthcare Diagnostic Limited Siemens Healthcare Diagnostic Limited Siemens Healthcare Diagnostic Limited Siemens Healthcare Diagnostic Limited Siemens Healthcare Diagnostic Limited Stryker China Ltd Stryker China Ltd
N/A N/A N/A N/A N/A N/A N/A N/A N/A 2593 2211 3157 7220 2907 5911 2277 6125 2810 7533 2810 7533 2810 7533 2810 7533 2810 7533 2810 7533 2518 6988 2518 6988
Medical Device Control Office
30
Department of Health The Government of HKSAR
SN081123 SN081124 SN081125 SN081126 SN081127 SN081128 SN081129 SN081130 SN081131 SN081132 SN081133 SN081134 SN081135 SN081136 SN081137 SN081138 SN081139 SN081140 SN081141 SN081142 SN081143 SN081144 SN081145 SN081146
GE Centricity Perinatal (formerly Quantitative Sentinel) System Fluid Total Precision Software Baxter Auto Syringe AS50 Infusion Pump (Product Code 1M8550) Roche Diagnostic LDL_C, IRON2, CREP2, STFR, HDLC3, ALBT2, NAPA2 Roche/Hitachi Modular E Module immunoassay analyzer (GMMI Nos. 04998642001 and 03617505001) Philips Respiratory Gating System (Model # 455011203131 and 455011203191) Philips M3811B Telemonitoring Clinical Review Software (version Build 1.1.2.11d, B.02.07) Smith & Nephew GlobTek, Inc. Power Supply for Medical Use (Par no: TR9CE4000LCP-Y-MED Model GTM21097-5012) Facet Technologies Premier Value Lancing Device (UPC Code: 840986016707) Biomet brand Modular Microplasty Cup Inserter (Model 31-400600) Pointe Scientific Liquid AST (SGOT) Reagent Set, AST R1 Reagent Maquet Accessory Head Rest for Alphastar Operating Tables (USA Part no 1130 67FO) Allez Spine Laguna Pedicle Screw System, Del Mar Pedicle Screw System, Cross Connectors Intraop Medical Mobetron Model 1000, mobile electron linear accelerator Medline Latex Free C- Section CDS-LF, Vaginal Delivery CDS-LF, Labor Kit & Postpartum CDS-LF, Mom/Baby Admit Kit-LF Hill-Rom Envision E700 Low Airloss Therapy Surface Applied Medical Separator Abdominal Access System, Lap Banding Kit, Lap Roux-EN-Y Kit Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System Cook Endoscopy Zilver Expandable Metal Biliary Stent System, ZILBS-10-6 Joerns Healthcare Mermaid, Dipper and Ranger bath hoists Tosoh Bioscience TSKgel G8 Variant HSi Roche Diagnostics MODULAR ANALYTICS Software version 08.03 Siemens Syngo Imaging CODAN Pressure Monitoring Kit STP-90R Stryker Humerus Head Fixed and HMRS - Distal Humerus Cone
FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA MHRA MHRA MHRA MHRA MHRA MHRA
Z-0112-2009 Z-0152-2009 Z-0006-2009 to Z-0012-2009 Z-0165-2009 Z-0132-2009 Z-0100-2009 Z-0162-2009 Z-0174-2009 Z-0181-2009 Z-0171-2009 Z-0161-2009 Z-0153-2009 to Z-0155-2009 Z-0014-2009 Z-0015-2009 to Z-0019-2009 Z-0088-2009 Z-0023-2009 to Z-0029-2009 Z-0035-2009 to Z-0085-2009 Z-0113-2009 MDA/2008/079 2008/011/003/061/010 2008/010/030/061/016 2008/010/031/061/003 2008/002/028/401/002 2008/010/015/061/005
Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II MDA FSCA FSCA FSCA FSCA FSCA
2008/11/10 2008/11/10 2008/11/10 2008/11/10 2008/11/10 2008/11/10 2008/11/10 2008/11/10 2008/11/10 2008/11/10 2008/11/10 2008/11/10 2008/11/10 2008/11/10 2008/11/10 2008/11/10 2008/11/10 2008/11/10 2008/11/10 2008/11/10 2008/11/10 2008/11/10 2008/11/10 2008/11/11
GE Medical Systems Hong Kong Ltd. Baxter Healthcare Ltd Roche Diagnostics (Hong Kong) Ltd Roche Diagnostics (Hong Kong) Ltd Philips Healthcare - Great China Philips Healthcare - Great China Smith & Nephew Limited N/A N/A N/A Maquet Hong Kong Ltd N/A N/A N/A N/A N/A N/A Cook Asia (Hong Kong) Ltd. N/A N/A Roche Diagnostics (Hong Kong) Ltd Siemens Healthcare Diagnostic Limited N/A Stryker China Ltd
2783 1838 2807 8500 2485 7510 2485 7510 2821 5480 2821 5480 2648 7700 N/A N/A N/A 2393 9511 N/A N/A N/A N/A N/A N/A 2781 0232 N/A N/A 2485 7510 2810 7533 N/A 2518 6988
Medical Device Control Office
31
Department of Health The Government of HKSAR
SN081147 SN081148 SN081149 SN081150 SN081151 SN081152 SN081153 SN081154 SN081155 SN081156 SN081157 SN081158 SN081159 SN081160 SN081161 SN081162 SN081163 SN081164 SN081165 SN081166 SN081167 SN081168 SN081169 SN081170 SN081171 SN081172 SN081173 SN081174
Biomet AGC V2 Total Knee Moulded ArComTibial Components ThermoFisher BO0077M, Tryptone soya broth GE Healthcare Signa MR 2239500, 5116064 and 5118162 Bio-Rad Variant II Turbo Hemoglobin Testing System with CDM 4.0 Bio-Rad Variant II Turbo HCook Zenith Flex AAA Endovascular Graft emoglobin Testing System with CDM 4.0 Maquet Pedal 1009.81 for operating tables KYMCO Healthcare Midi XL Days healthcare Strider Maxi and Strider Midi 4+ Sunrise Medical OXFORD Midi 150A lifts Marshall Products adult and paediatric manual resuscitators TSCI Fluido SA 200 Biomet Vanguard Width Checker 67.5 / 70 / 75 Siemens AG Syngo Imaging (Model 10014063) B-K Medical Single Use Sterile Puncture UA 1256-U Roche Hitachi D-Dimer Kerr Premise Unidose Ondal Stryker Vision 3 Elect Mon Shroud Ondal Flat Panel/Navigation Arm Biomet Microfixation Lactosorb 1.5MM 8Hole STR EXT Plate GE Centricity PACS Software Medtronic Synchromed EL, Synchromed II infusion pumps Terumo Advanced Perfusion System 1 Synthes sternal Fixation System - Cable Ferrule Siemens Somatom Sensation / Cardiac 64 Tripath Prepstain System Medrad 3.0 T Prostat eCoil Terumo Level Sensor Transducer TomoTherapy Hi-Art System
MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada
2008/009/025/401/008 2008/011/005/601/005 2008/011/004/051/004 2008/011/005/061/009 2008/008/007/061/009 2008/011/003/061/013 2008/010/027/261/001 2008/010/023/301/002 2008/004/014/401/003 2008/010/029/401/001 2008/011/006/051/008 40888 44245 44063 43711 44081 44076 44179 43369 42408 44005 42752 44393 44298 44291 44234 43401 44265
FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II
2008/11/11 2008/11/11 2008/11/11 2008/11/11 2008/11/12 2008/11/12 2008/11/12 2008/11/12 2008/11/13 2008/11/13 2008/11/13 2008/11/14 2008/11/14 2008/11/14 2008/11/14 2008/11/14 2008/11/14 2008/11/14 2008/11/14 2008/11/14 2008/11/14 2008/11/14 2008/11/14 2008/11/14 2008/11/14 2008/11/14 2008/11/14 2008/11/14
N/A N/A GE Medical Systems Hong Kong Ltd. N/A Cook Asia (Hong Kong) Ltd. Maquet Hong Kong Ltd N/A N/A N/A N/A N/A Goodman Medical Supplies Ltd Siemens Healthcare Diagnostic Limited S & V Sanford Instrument Roche Diagnostics (Hong Kong) Ltd N/A Stryker China Ltd Stryker China Ltd Goodman Medical Supplies Ltd GE Medical Systems Hong Kong Ltd. Medtronic International, Ltd. TERUMO CHINA (H.K.) LTD. N/A Siemens Healthcare Diagnostic Limited BD Asia Ltd (Hong Kong) Ultronics Enterprises Ltd TERUMO CHINA (H.K.) LTD. N/A
N/A N/A 2783 1838 N/A 2781 0232 N/A N/A N/A N/A N/A N/A 2332 4455 2810 7533 N/A 2485 7510 N/A 2518 6988 2518 6988 2332 4455 2783 1838 2907 5911 2866 0811 N/A 2810 7533 2575 8668 2764 5208 2866 0811 N/A
Medical Device Control Office
32
Department of Health The Government of HKSAR
SN081175 SN081176 SN081177 SN081178 SN081179 SN081180 SN081181 SN081182 SN081183 SN081184 SN081185 SN081186 SN081187 SN081188 SN081189 SN081190 SN081191 SN081192 SN081193 SN081194 SN081195 SN081196 SN081197 SN081198 SN081199
Gambro Prismaflex system Gerno Model 35X Proflexx Stretcher BC Unicel DXC 6001 Assay Protocol File, Access Immunoassay system Protocol file, Access System 2 Protocol File, Sysnchron LXI 725 Assay Protocol file Pascal Siltrax Plus 8 Gingival Retraction Cord ACS Holter Reporter Master VII Analyzer Angio 3-0 Nylon Suture Product Thomas Medical Products 18 gage XTW needles 7F Bard SSV 13 cm Split Sheath with Valve and sideport (Catalog No: 808700) Sunquest Laboratory versions 5.3, 5.4, 6.1, 6.2 and 6.3 Drummond Scientific Iris Sample Processing SafeCrit 75mm and 40mm Tubes, Separation Technology ClearCRIT Capillary Tubes Iverness Medical BioStar OIA FLU AB (Catalog 90007) Pointe Scientific Liquid Glucose HEX (R1); HEX (R2); HEX; HEXO Reagent Sets Porter Instrument Bag Tee Assembly Model (P1407A) Biomet Microfixation HT X-Drive Screw Advanced Bionics Preision Charger 1.0 (Model # SC-5300) Alcon PurePoint System Operator's Manual (Catalog no 8065751131 Rev. B) Terumo Sarns Level Sensor II (Yellow and Red) (Part # 195215 and # 195274) TERUMO Advanced Perfusion System 1 Base (Model 801763 and 801764) Siemens AXIOM Artis and Artis zee Animas (Johnson & Johnson ) One Touch Ping Glucose Monitoring System Stryker Hipstar V40 Femoral Stem Howemedica Gyrus ACMI (Olympus) dissector PlasmaKnife (DPK) (Catalog no 7035-3005) Philips Intera, Achieva and Panorama HFO (Philips MR), 3160 (Precess) MRI Patient Monitoring System (Invivo) Unomedical Unilect 4831Q and 4841P Short Term Monitoring Electrodes Siemens ADVIA Centaur® and ACS:180® Systems
Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA MHRA MHRA MHRA
44403 44082 44259 43384 43854 44163 Z-0131-2009 Z-0280-2009 Z-0207-2009 Z-0208-2009 to Z-0211-2009 Z-0212-2009 Z-0219-2009 to Z-0224-2009 Z-0228-2009 Z-0282-2009 Z-0271-2009 Z-0274-2009 Z-0295-2009 to Z-0296-2009 Z-0203-2009 to Z-0204-2009 Z-0193-2009 to Z-0194-2009 Z-0283-2009 Z-0227-2009 Z-0273-2009 2008/009/025/061/013 2008/010/023/061/011 2008/011/004/061/009
Type II Type II Type II Type II Type II Type I Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II FSCA FSCA FSCA
2008/11/14 2008/11/14 2008/11/14 2008/11/17 2008/11/17 2008/11/17 2008/11/17 2008/11/17 2008/11/17 2008/11/17 2008/11/17 2008/11/17 2008/11/17 2008/11/17 2008/11/17 2008/11/17 2008/11/17 2008/11/17 2008/11/17 2008/11/17 2008/11/17 2008/11/17 2008/11/17 2008/11/18 2008/11/18
Gambro China Ltd Goodman Medical Supplies Ltd Beckman Coulter Hong Kong Ltd N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A Alcon Hong Kong Ltd TERUMO CHINA (H.K.) LTD. TERUMO CHINA (H.K.) LTD. Siemens Healthcare Diagnostic Limited Johnson & Johnson Medical (HK) Stryker China Ltd Olympus Hong Kong and China Limited Philips Healthcare - Great China N/A N/A
N/A 2332 4455 2240 6150 N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A 2568 0636 2866 0811 2866 0811 2810 7533 2738 6027 2518 6988 2170 5678 2821 5480 N/A N/A
Medical Device Control Office
33
Department of Health The Government of HKSAR
SN0811100
B Braun Diacap Ultra Dialysis Fluid and Online Filter, 7107366 and 7107365
MHRA MHRA Johnson & Johnson Medical (HK) Baxter Healthcare Ltd MHRA MHRA MHRA MHRA FDA FDA FDA MHRA MHRA MHRA MHRA MHRA Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada MHRA FDA FDA FDA FDA
2008/010/007/061/011 2008/010/030/061/008 N/A N/A 2008/011/005/601/001 2008/011/013/061/003 2008/011/011/291/008 2008/011/014/061/012 Z-0287-2009 Z-0214-2009 Z-0218-2009 2008/011/014/061/008 2008/004/021/061/008 2008/009/002/061/011 2008/011/019/061/021 2008/011/018/601/002 44383 44442 44527 44440 44551 44535 2008/011/003/061/012 Z-0004-2009 Z-2388-2008 Z-0309-2009 to Z-0310-2009 Z-0306-2009
FSCA FSCA Firm Initiated Field Action Firm Initiated Field Action FSCA FSCA FSCA FSCA Class II Class II Class II FSCA FSCA FSCA FSCA FSCA Type II Type II Type II Type II Type II Type II FSCA Class II Class II Class II Class II
2008/11/18 2008/11/18 2008/11/19 2008/11/19 2008/11/20 2008/11/20 2008/11/20 2008/11/20 2008/11/21 2008/11/21 2008/11/21 2008/11/21 2008/11/21 2008/11/21 2008/11/24 2008/11/24 2008/11/24 2008/11/24 2008/11/24 2008/11/24 2008/11/24 2008/11/24 2008/11/26 2008/11/28 2008/11/28 2008/11/28 2008/11/28
B Braun Medical Hong Kong Stryker China Ltd Johnson & Johnson Medical (HK) Baxter Healthcare Ltd Beckman Coulter Hong Kong Ltd N/A N/A N/A Boston Scientific Hong Kong Ltd N/A N/A N/A Johnson & Johnson Medical (HK) N/A Philips Healthcare - Great China GE Medical Systems Hong Kong Ltd. N/A Siemens Healthcare Diagnostic Limited Foxwood Medical Supplies Smiths Medical (S.E. Asia) Ltd. Siemens Healthcare Diagnostic Limited Arjo Huntleigh (Hong Kong) Ltd N/A Johnson & Johnson Medical (HK) Medtronic International, Ltd. TERUMO CHINA (H.K.) LTD. Abbott Laboratories Ltd.
2277 6125 2518 6988 2738 6027 2807 8516 2240 6150 N/A N/A N/A 2960 7136 N/A N/A N/A 2738 6027 N/A 2821 5480 2783 1838 N/A 2810 7533 2770 6877 2317 0988 2810 7533 2508 9553 N/A 2738 6027 2907 5911 2866 0811 2593 2211
SN0811101 Stryker V40 ORTHINOX femoral head 28/-4 mm & 28/0 mm SN0811102 Johnson & Johnson Sterrad 100S Sterilizers SN0811103 Baxter COLLEAGUE Triple Channel Mono CX and CXE Volumetric Infusion Pumps (Product Codes: 2M8153K)
SN0811104 Beckman Coulter Power Processor with LX Connections, 6605741 SN0811105 Clinical Innovations ClearView Uterine Manipulator SN0811106 Coloplast EasiCath Catheter and EasiCath Luer Lock Catheter SN0811107 Stanmore Implants METS Femoral Shaft Boston Scientific NAMIC Custom Angiographic Kit SN0811108 (REF/Catalog#60190254) SN0811109 SN0811110 Sunquest Laboratory System (Software version: Sunquest Laboratory v5.4.2, v6.1, v6.2 and v6.3) Gabauer's Fluro-Ethyl Nonflammable Topical Anesthetic Skin Refrigerant (Aerosol Can) (P/N 0386-0020-20)
SN0811111 Smith & Nephew SOFTSILK 1.5 SCREW, 8mm x 20mm SN0811112 Codman, A J&J Archimedes implantable infusion pump SN0811113 Comis Orthopaedics MIHR Modular Femoral Head Sleeve Size 0, product code 028-10-2
Philips IntelliVue Patient Monitors (the table mount, part# M8000SN0811114 64100) SN0811115 GE Giraffe OmniBed (Cleaning & Care Guidelines) SN0811116 Phadia Varelisa U1RNP Antibodies Kit (model 17096) SN0811117 Siemens Axiom Luminos DRF (Model 10252047) SN0811118 Fisher and Paykel RT240 & RT340 Adult Breathing Circuit SN0811119 Smiths Potex Blue Line Ultra Tracheostomy Kit (Model 100/812/070) SN0811120 Siemens Symbia T Series (Model 10275009) SN0811121 SN0811122 SN0811123 SN0811124 BHM Arjo Maxi 500 (KM560101, KM560104, KM560108, KM560181, KM560184, KM560188) Bard WIZARD Dual Port Low Profile Replacement Gastrostomy Device Johnson and Johnson Lifescan One Touch Litra Test Strips (Part no 020-994-02) Medtronic Physio-Control Lifepak 20 Defibrillator/monitor
SN0811125 Terumo Advanced Perfusion System 1 (Model 801040 and 801041) Abbott CELL-DYN Sapphire Hematology Analyzer (List no 08H00SN0811126 01, 08H00-03)
Medical Device Control Office
34
Department of Health The Government of HKSAR
SN0811127
Biomet Vanguard DCM Plus 16mm x 63/67mm Tibial Bearing (REF 183726)
FDA FDA FDA FDA
Z-0289-2009 Z-0299-2009 to Z-0304-2009 Z-0308-2009 Z-0272-2009
Class II Class II Class II Class II
2008/11/28 2008/11/28 2008/11/28 2008/11/28
N/A Zimmer PTE Ltd. (Hong Kong branch) N/A N/A
N/A 2992 0968 N/A N/A
SN0811128 Zimmer Alumina Ceramic Femoral Head Stelkast Proven Cemented Semi-Constrained Total Knee (Part No. SN0811129 SC1591-38) SN0811130 Theken Spine Bone Marrow Aspiration Kit (Part no 50-20-001)
Medical Device Control Office
35
Department of Health The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - October 2008
Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. Description of Product No. Medtronic INDURA 1P Intrathecal Catheter (Model 8709SC), Intrathecal Catheter (Model 8731SC), Sutureless Pump Connector SN081001 Revision Kit (Model 8678) and Intrathecal Catheter Pump Segment Revision Kit (Model 8596SC) SN081002 SN081003 SN081004 SN081005 SN081006 SN081007 SN081008 SN081009 SN081010 SN081011 SN081012 SN081013 SN081014 SN081015 SN081016 SN081017 SN081018 SN081019 SN081020 SN081021 SN081022 Medtronic IsoMed Refill Kit (Model 8553) Stryker Osteonics Scorpio Total Knee Stryker Hoffman II compact Sterile Wrist Kit Stryker Universal Notch Preparation Guide amd X-Celerate Universal Block Pegless GE Healthcare Definium 8000 Digital Radiographic System GE Healthcare Definium 8000 Digital Radiographic System GE Definium 8000 (model 5135678) and GE Precision 500D (model 2403790-3) GE OEC 9600 C-arm Fluoroscopy System GE 1.5T and 3.0 T Signa HDx MR System and GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System Siemens Radiation Therapy Systems Siemens Ultrasound Transducer 17L5HD Accuray CyberKnife Ronotic Radiosurgery System radiation therapy device Varian VariSource CT/MR Ring & Tandem Applicator Set Smith & Nephew TRIGEN Hind Foot Fusion Nail Merit Medical Arnot-Ogden Med Ctr Hip Pack (REF: K12T-02160A and K12T-02159A) Naviscan PEM Flex Solo II PET Scanner Biogenex Laboratories Xmatrx FISH Automated Staining System Abbott Total Bilirubin Immucor Galileo Echo ConMed VCareR Uterine Manipulators Sendal 3101-TJ Transfusion Set Source of Information FDA Reference No. by Source Alert Type by Source Date of Issue (YYYY/MM/DD) 02-Oct-08 Local Agent Agent Contact Telephone No 2907 5911
Z-2380-2008 to Z-2383-2008
Class I
Medtronic International, Ltd.
FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA MHRA MHRA MHRA MHRA
Z-1903-2008 Z-2079-2008 Z-2080-2008 Z-1690-2008 to Z-1691-2008 Z-1822-2008 Z-1882-2008 Z-1476-2008 to Z-1477-2008 Z-1709-2008 Z-2210-2008 to Z-2211-2008 Z-2095-2008 to Z-2104-2008 Z-2230-2008 Z-2056-2008 Z-2081-2008 Z-2082-2008 to Z-2088-2008 Z-1808-2008 to Z-1809-2008 Z-2229-2008 Z-1471-2008 2008/009/018/601/005 2008/009/022/061/013 2008/009/002/061/001 2008/009/011/061/010
Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II FSCA FSCA FSCA FSCA
02-Oct-08 02-Oct-08 02-Oct-08 02-Oct-08 02-Oct-08 02-Oct-08 02-Oct-08 02-Oct-08 02-Oct-08 02-Oct-08 02-Oct-08 02-Oct-08 02-Oct-08 02-Oct-08 02-Oct-08 02-Oct-08 02-Oct-08 02-Oct-08 02-Oct-08 02-Oct-08 02-Oct-08
Medtronic International, Ltd. Stryker China Ltd Stryker China Ltd Stryker China Ltd GE Medical Systems Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. Siemens Healthcare Diagnostic Limited Siemens Healthcare Diagnostic Limited Accuray Asia Ltd Varian Medical Systems Pacific Inc. Smith & Nephew Limited N/A N/A N/A Abbott Laboratories Ltd. N/A N/A N/A
2907 5911 2518 6988 2518 6988 2518 6988 2783 1838 2783 1838 2783 1838 2783 1838 2783 1838 2810 7533 2810 7533 2247 8628 2724 2836 2645 8703 N/A N/A N/A 2806 4021 N/A N/A N/A
Medical Device Control Office
36
Department of Health The Government of HKSAR
SN081023 SN081024 SN081025 SN081026 SN081027 SN081028 SN081029 SN081030 SN081031 SN081032 SN081033 SN081034 SN081035 SN081036 SN081037 SN081038 SN081039 SN081040 SN081041 SN081042 SN081043 SN081044 SN081045 SN081046 SN081047 SN081048
Diagnostica Stago (STA) Neoplastine CI (Plus) 10 Spacelabs Ultraview Digital Telemetry Reciever, model 90478 ThermoFisher Tryptone soya broth BO0351G Nebion, LLC HLX-8 Magnetic Resonance Device Kimal K-Flow access catheters Draeger Zeus Anaesthetic machines software version 4.01 GENICON 5 mm Pyramidal Trocars GE Healthcare Aisys Anaesthesia machine Remploy Access and Accent attendant propelled wheelchairs Park House Alternating air mattress pumps models PHP198,396, 398 and 399 Hoggi BINGO Rehab Pushchair Sunrise Medical Breezy Moonlite Wheelchairs Hologic: ATEC 1212-20 Handpieces ThermoFisher Columbia Blood Agar, PB0122A Siemens Medical Solutions Diagnostics ADVIA Chemistry Controls 1 and 2 Abbott ClearStar model number M771 Baxter FLOGARD 6201 Volumetric Infusion Pump (Product Code 2M8063) NeoMedix Trabectome I/A Console, Model Number 550014, surgical aspirator GE Healthcare OEC 9900 mobile fluoroscopic x-ray system GE Healthcare Innova 3100 and 4100 Digital Fluoroscopic Imaging System with Bolus Chasing ev3" 55442-2920, sterile EO, single Use, Visi-Pro BalloonExpandable Peripheral Puritan-Bennett 800 Series Ventilator Backup Power Source (BPS) Model 802 Toshiba America Medical Systems (TAMS) Aquilion 32 CT and 64 CT system, computed tomography x-ray system Siemens Medical Solutions, syngo Dynamics 6.0 Workplace; Picture archiving and communication system Siemens Medical Solutions, Mevatron Digital Linear Accelerator X-STOP Interspinous Process Decompression (lPD) System
MHRA MHRA MHRA FDA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA Baxter Healthcare Ltd FDA FDA FDA FDA FDA FDA FDA FDA FDA
2008/009/025/061/010 2008/008/014/061/012 2008/009/023/601/003 N/A 2008/008/026/401/004 2008/009/015/051/009 2008/009/026/061/009 2008/009/025/061/011 MDA/2008/070 MDA/2008/071 2008/005/030/061/019 2008/005/028/401/006 2008/009/026/061/014 2008/010/002/601/002 2008/010/001/061/008 2008/010/001/061/012 N/A Z-0071-2008 Z-0368-2008 Z-1516-2008 to Z-1517-2008 Z-1547-2008 Z-1692-2008 Z-1707-2008 to Z-1708-2008 Z-1751-2008 Z-1753-2008 to Z-1763-2008 Z-1765-2008
FSCA FSCA FSCA Class I FSCA FSCA FSCA FSCA MDA MDA FSCA FSCA FSCA FSCA FSCA FSCA Firm Initiated Field Action Class II Class II Class II Class II Class II Class II Class II Class II Class II
02-Oct-08 02-Oct-08 02-Oct-08 06-Oct-08 06-Oct-08 06-Oct-08 06-Oct-08 06-Oct-08 08-Oct-08 08-Oct-08 08-Oct-08 08-Oct-08 09-Oct-08 09-Oct-08 09-Oct-08 09-Oct-08 10-Oct-08 13-Oct-08 13-Oct-08 13-Oct-08 13-Oct-08 13-Oct-08 13-Oct-08 13-Oct-08 13-Oct-08 13-Oct-08
Healthpro Technology Co. Ltd N/A N/A N/A N/A Draeger Medical Hong Kong Ltd. N/A GE Medical Systems Hong Kong Ltd. N/A N/A N/A N/A N/A N/A Siemens Healthcare Diagnostic Limited Abbott Laboratories Ltd. Baxter Healthcare Ltd N/A GE Medical Systems Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. N/A COVIDEN Sanko Medical Systems (HK) Ltd. Siemens Healthcare Diagnostic Limited Siemens Healthcare Diagnostic Limited N/A
N/A N/A N/A N/A N/A 2877 3077 N/A 2783 1838 N/A N/A N/A N/A N/A N/A 2810 7533 2806 4021 2807 8500 N/A 2783 1838 2783 1838 N/A 3157 7220 2384 0688 2810 7533 2810 7533 N/A
Medical Device Control Office
37
Department of Health The Government of HKSAR
SN081049 SN081050 SN081051 SN081052 SN081053 SN081054 SN081055 SN081056 SN081057 SN081058 SN081059 SN081060 SN081061 SN081062 SN081063 SN081064 SN081065 SN081066 SN081067 SN081068 SN081069 SN081070 SN081071 SN081072 SN081073 SN081074 SN081075
GE Centricity AW Suite software version 2.0 and 2.0.1 with Card IQ Xpress Pro or Plus Module; for diagnostic image analysis Cook Vital Port Vascular Access System Polysulfone Petite Brainlab VectorVision (VV) Sky Navigation Platform Biomet OSS (Orthopedic Salvage System) RS Non-Modular Long Tibial Base Applied Medical Silhouette Xtraflo Device with SL-6 Hydrophilic Coating Philips and Neusoft NeuViz Dual series computed Tomography Scanner System, X-Ray System Abaxis, Inc.Piccolo Chemistry Analyzer software version 6.121 Philips and Neusoft NeuViz Dual series computed Tomography Scanner System, X-Ray System Varian Medical Systems Eclipse device, model H48, Version 6.5 SCC Soft Computer SoftPath GUI Release Software Versions 3.17 and 4.1 Kyphon KyphX Osteo Introducer System with blunt tip introducer stylet Steris Small Renaissance Eagle 3000 Boston Scientific Platinum Plus Guidewire BD Ace Heat Therapy Zimmer Universal Optical Tracker Fixation, not sterile, REF 111.031 Smith & Nephew Caption Disposable Platelet Concentrator Kit Ref 71178200 and Ref 71178202 Siemens SOMATOM Emotion 6 and Emotion 16 Computed tomography X-ray system ConMed Linvatec Surgical Video Cart, Catalogue Number: VP8500 American Medical 700 CX MS Pump IZ, Preconnect Penoscrotal, 18 cm, Sterile EO, REF 72404232 SCC SoftPath ASCII Software Releases 1.2, 2.1, 2.2 and 2.3 BD Anaesthesia Kits and Epidural Filter GE Healthcare Advantage Workstation Suite-Card IQ GE Healthcare AMX Series Mobile RAD System(AMX 4 and AMX 4+ Thomas Medical Products SafetSheath family ThermoFisher Xpect Giardia/ Cryptosporidium Kit CASMED 500cc Single Patient Use Infusion Cuffs Boston Scientific Atlantis PV 15 MHz Imaging Catheter
FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA MHRA MHRA MHRA MHRA MHRA MHRA Boston Scientific Hong Kong Ltd
Z-2183-2008 Z-2190-2008 to Z-2191-2008 Z-2209-2008 Z-2213-2008 to Z-2214-2008 Z-2219-2008 to Z-2224-2008 Z-2235-2008 Z-2286-2008 to Z-2287-2008 Z-2307-2008 Z-2308-2008 Z-2329-2008 Z-2347-2008 Z-2350-2008 Z-2362-2008 to Z-2365-2008 Z-2431-2008 Z-2445-2008 Z-2446-2008 to Z-2447-2008 Z-2452-2008 to Z-2453-2008 Z-2458-2008 Z-2461-2008 Z-2463-2008 2008/010/006/061/006 2008/010/006/061/010 2008/010/002/061/004 2008/009/029/061/018 2008/008/014/061/008 2008/010/001/061/001 N/A
Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II FSCA FSCA FSCA FSCA FSCA FSCA Firm Initiated Field Action
13-Oct-08 13-Oct-08 13-Oct-08 13-Oct-08 13-Oct-08 13-Oct-08 13-Oct-08 13-Oct-08 13-Oct-08 13-Oct-08 13-Oct-08 13-Oct-08 13-Oct-08 13-Oct-08 13-Oct-08 13-Oct-08 13-Oct-08 13-Oct-08 13-Oct-08 13-Oct-08 14-Oct-08 14-Oct-08 14-Oct-08 14-Oct-08 14-Oct-08 14-Oct-08 15-Oct-08
GE Medical Systems Hong Kong Ltd. Cook Asia (Hong Kong) Ltd. BrainLAB Ltd. (Hong Kong) N/A N/A Philips Healthcare - Great China N/A Philips Healthcare - Great China Varian Medical Systems Pacific Inc. N/A N/A N/A Boston Scientific Hong Kong Ltd N/A Zimmer PTE Ltd. (Hong Kong branch) Smith & Nephew Limited Siemens Healthcare Diagnostic Limited N/A N/A N/A BD Asia Ltd (Hong Kong) GE Medical Systems Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. N/A N/A N/A Boston Scientific Hong Kong Ltd
2783 1838 2781 0232
N/A N/A 2821 5480 N/A 2821 5480 2724 2836 N/A N/A N/A 2960 7136 N/A 2992 0968
2645 8703 2810 7533 N/A N/A N/A 2575 8668 2783 1838 2783 1838 N/A N/A N/A 2960 7136
Medical Device Control Office
38
Department of Health The Government of HKSAR
SN081076 SN081077 SN081078 SN081079 SN081080 SN081081 SN081082 SN081083 SN081084 SN081085 SN081086 SN081087 SN081088 SN081089 SN081090 SN081091 SN081092 SN081093 SN081094 SN081095 SN081096 SN081097 SN081098 SN081099 SN0810100 SN0810101
Boston Scientific Excelsior SL-10 Microcatheter Medtronic (Physio-Control) LIFEPAK CR Plus defibrillator/ LIFEPAK EXPRESS defibrillator Acumed Locking Tarsometatarsal Plate, Locking Proximal Metatarsal Wedge Plate, Locking Clavicle Plate Portland Orthopaedics Margron DTC Hip Replacement System Curlin Medical Model 2000, 4000 and 600 CMS/ Plus Ambulatory Infusion Pump, PainSmart, PainSmart IOD Ambulatory Infusion System ArthroCare ArthroWand Covator with Integrated Cable Wand (Catalog no AC4340-01) Spacelabs Medical Temperature Probe Adaptor PN-700-0031-00 Propper short gas-chex EO sterilization indicators (Recorder no 269001) Oscor Permanent Pacing Lead Smiths Medical Deltec 3000 Large Volume Infusion Pump and Deltec Micro 3100 Large Volume Infusion Pump Nova Biomedical Varta Easypack XL Lithium Polymer Batteries (P/N 41772 and 42215) Stryker Rejuvenate Broach Stryker 6.5 Cancellous Bone Screw 25mm (Catalog No 2030-65251) AMO WaveScan WaveFront System Version 3.90/3.901 (Part No. 0070-1478) Abbott Flexiflo Quantum Pump Set (List # 50604) Siemens Acuson CV70 Ultrasound Systems Medtronic SPECIFY 3998 Lead Kit for Spinal Cord Stimulation (SCS) GE Innova 3100/3100IQ, 2100IQ, 4100/4100IQ, Advantx-E, Innova 2121-1Q/2121-1Q and Innova 2000 GE Precision RXi Digital remote X-Ray Imaging R&F System (model 5117828) GE Definium 800 Digital Radiographic System (Model 5135678) GE Datex-Ohmeda Engstrom Carestation GE Proteus XR/a Eclipse Collimator (Model # 2379827) GE Precision 500D and Advantx Legacy Radiographic and Fluoroscopic systems GE Innova 3100 Digital Fluoroscopic Imaging and Innova 4100 Digital Fluoroscopic Imaging GE OEC 9800 Fluoroscopic X-Ray System and OEC 9900 Elite Fluoroscopic X-Ray System Siemens Dimension Clinical Chemistry System - Enzymatic Creatinine Flex Reagent Cartridge DF270
Boston Scientific Hong Kong Ltd Medtronic International Ltd FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA MHRA
N/A N/A Z-2108-2008 to Z-2132-2008 Z-1931-2008 to Z-2001-2008 Z-1896-2008 to Z-1900-2008 Z-2309-2008 Z-2314-2008 Z-2330-2008 Z-2333-2008 Z-1604-2008 to Z-1605-2008 Z-1472-2008 Z-2349-2008 Z-2007-2008 Z-2310-2008 Z-2305-2008 Z-2212-2008 Z-2241-2008 Z-2356-2008 to Z-2361-2008 Z-2145-2008 Z-1883-2008 Z-1829-2008 Z-1713-2008 Z-1610-2008 to Z-1611-2008 Z-1521-2008 to Z-1522-2008 Z-1885-2008 2008/010/007/061/010
Firm Initiated Field Action Firm Initiated Field Action Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II FSCA
15-Oct-08 15-Oct-08 16-Oct-08 16-Oct-08 16-Oct-08 16-Oct-08 16-Oct-08 16-Oct-08 16-Oct-08 16-Oct-08 16-Oct-08 16-Oct-08 16-Oct-08 16-Oct-08 16-Oct-08 16-Oct-08 16-Oct-08 16-Oct-08 16-Oct-08 16-Oct-08 16-Oct-08 16-Oct-08 16-Oct-08 16-Oct-08 16-Oct-08 17-Oct-08
Boston Scientific Hong Kong Ltd Medtronic International, Ltd. N/A N/A N/A ArthoCare Asia Pacific N/A N/A N/A N/A N/A Stryker China Ltd Stryker China Ltd AMO Asia Limited Abbott Laboratories Ltd. Siemens Healthcare Diagnostic Limited Medtronic International, Ltd. GE Medical Systems Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. Siemens Healthcare Diagnostic Limited
2960 7136 2907 5911 N/A N/A N/A 2159 7436 N/A N/A N/A N/A N/A 2518 6988 2518 6988 2480 3330 2806 4021 2810 7533 2907 5911 2783 1838 2783 1838 2783 1838 2783 1838 2783 1838 2783 1838 2783 1838 2783 1838 2810 7533
Medical Device Control Office
39
Department of Health The Government of HKSAR
SN0810102 SN0810103 SN0810104 SN0810105 SN0810106 SN0810107 SN0810108 SN0810109 SN0810110 SN0810111 SN0810112 SN0810113 SN0810114 SN0810115 SN0810116 SN0810117 SN0810118 SN0810119 SN0810120
Spacelabs Healthcare 90496 and 91496 Command Module NIBP Option Johnson & Johnson Biosense Webster NAVISTAR RMT 4mm, 8nn DS and THERMOCOOL Catheters Varian C-Series Clinac Linear Accelerator Varian Acuity, Ximatron Immucor Galileo / Capture-R Ready test wells Immucor Galileo Echo / CaptureR Ready Scrn strip Ferno 35-A Mobile Transporter Anspach effort A) 12.6mm Boring Tool, B) 9.5mm Boring Tool Cardinal Health Custom Sterile Procedure Pack Sirona Dental System GMBH Galileos 3D X-Ray with Galaxis 1.5 Siemen Axiom Artis, Axiom Artis DMP Roche Cobas Integra System-Smphetamines, Roche Hitachi-Online Amphetamines Welch Allyn Fiber Optic Sigmoidoscope, Insufflation Bulbs Cybernius Medical Nepfrocare Software Biomerieux Oberva Data Management System Stryker Communication Ophit DVI Extender Immco Diagnostic West Nile Virus IGG Indirect Elisa Griener Bio One Vacuette Lithium Heparin Blood Collection Tube Bausch & Lomb Medalist Toric (SofLens 66 Toric) Contact Lenses (Lot no. W64067390, W64067389, W64067246) and Medalist One Day Plus, SofLens daily disposable (hilaflcon B) Visibility Tinted Contact Lenses (Lot no X10050809A and R10050805A) ThermoFisher EB0212E, Cooked meat medium, lot number 1048169 Qualigen Fast Pack Total PSA Lot 0807002 Orasure Oral Fluid Positive Control, Oral Fluid Negative Control, Oral Fluid Cutoff Calibrator Radiometer ABL700 Series Calibration 1 Solution Nucletron Oncentra Prostate System (with option CT/MRI imaging) BD Vacutainer Blood Collection Tubes Homecraft Rolyan 2" and 4" Savanah raised toilet seats Lomax Mobility Kid Active folding manual wheelchair with swing away footrests Boston Scientific TruPath Biopsy Device and easy Core Biopsy Device Boston Scientfic easyCore Biopsy System (Endoscopy) Steris Quick Connect component (p/n 201048)
MHRA MHRA Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Bausch & Lomb (Hong Kong) Limited MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd FDA
2008/010/003/061/005 2008/010/009/061/005 44028 43747 43677 43678 43920 43458 43591 43380 43745 43716 43629 43736 42986 43879 43722 43583 N/A
FSCA FSCA Type I Type I Type I Type I Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Firm Initiated Field Action FSCA FSCA FSCA FSCA FSCA FSCA MDA MDA Firm Initiated Field Action Firm Initiated Field Action Class II
17-Oct-08 17-Oct-08 17-Oct-08 17-Oct-08 17-Oct-08 17-Oct-08 17-Oct-08 17-Oct-08 17-Oct-08 17-Oct-08 17-Oct-08 17-Oct-08 17-Oct-08 17-Oct-08 17-Oct-08 17-Oct-08 17-Oct-08 17-Oct-08 21-Oct-08
N/A Johnson & Johnson Medical (HK) Varian Medical Systems Pacific Inc. Varian Medical Systems Pacific Inc. N/A N/A Goodman Medical Supplies Ltd N/A N/A N/A Siemens Healthcare Diagnostic Limited Roche Diagnostics (Hong Kong) Ltd Ultronics Enterprises Ltd N/A Biomerieux China Ltd (HK) Stryker China Ltd N/A Mekim Ltd Bausch & Lomb (Hong Kong ) Ltd
N/A 2738 6027 27242836 27242836 N/A N/A 2332 4455 N/A N/A N/A 2810 7533 2485 7510 2764 5208 N/A 2356 7033 2518 6988 N/A 2774 8300 2213 3371
SN0810121 SN0810122 SN0810123 SN0810124 SN0810125 SN0810126 SN0810127 SN0810128 SN0810129 SN0810130 SN0810131
2008/010/007/601/002 2008/010/010/061/004 2008/010/010/061/006 2008/009/008/061/002 2008/006/027/401/003 2008/009/006/601/001 MDA/2008/075 MDA/2008/076 N/A N/A Z-2462-2008
23-Oct-08 23-Oct-08 23-Oct-08 23-Oct-08 23-Oct-08 23-Oct-08 24-Oct-08 24-Oct-08 24-Oct-08 24-Oct-08 27-Oct-08
N/A N/A N/A N/A N/A BD Asia Ltd (Hong Kong) N/A N/A Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd Swedish Trading Co., Ltd
N/A N/A N/A N/A N/A
N/A N/A 2960 7136 2960 7136
Medical Device Control Office
40
Department of Health The Government of HKSAR
SN0810132 SN0810133 SN0810134 SN0810135 SN0810136 SN0810137 SN0810138 SN0810139 SN0810140 SN0810141 SN0810142 SN0810143 SN0810144 SN0810145 SN0810146 SN0810147 SN0810148 SN0810149 SN0810150 SN0810151 SN0810152 SN0810153 SN0810154 SN0810155 SN0810156 SN0810157 SN0810158 SN0810159 SN0810160 SN0810161 SN0810162 SN0810163 SN0810164
Philips Ultraview Digital Telemetry Transmitter (Model 91341-09) Zimmer Quicklock Tracker (Size 2, Ref 111.100) Sunrise Medical Quickie Groove Power Wheelchair with Transit option Biomet Exact Calcar Planer Rasp Style Blade (REF 31-473795 to 31-473798) Cardinal Health NicoletOne photic adapter cable 085-463700 Angiodynamics Centros Chronic Hemodialysi Curved Catheter Set (Catalog no./REF 10303101 to 10303103) Arjo Kwiktrak Gate System B. Braun Horizon Pump Set, Adult Metriset, Safeline Metriset, Metriset Burette Set, Burette Set, Add-On Burette Set ACIST BRACCO AT P54 AngioTouch Kit Beckman Coulter Synchron Acetaminophen (ACTM) Reagent (Part No. 472169) Cardinal Health NicoletOne 5.30.2 Software Boston Scientific easy Core Biopsy Device (Peripheral Interventions) Baylis Medical BMC RF Cannula - Part # PMF20-100-10CS; Lot PFFA211107 GE Healthcare Giraffe and Panda Warmers Medtronic OptiVol CareAlert and CareLink Transmissions Issue Invacare Typhoon 1 & 2 Power Wheelchairs Thoratec HeartMate II LVAS Helena Laboratories Manual D-dimer 5250 Metrax Primedic DefiMonitor XD Series Tryton Side Branch Stent Inverness Panbio West Nile Virus IgM Capture ELISA Biomet 2.00mm Crimp Sleeve, item: 350805, lot 568400 Edwards Lifesciences Vigilance II Monitor VIG2/VIG2E Stryker Circlip retaining system Stryker System 6 and Cordless Driver 3 Handpiece Respironics BIPAP Focus Ventilator System Siemens IMMULITE® 2000/2500 Substrate Module L2SUBM 252 DLS Medical Wound dressing pack avm3550, Woundcare pack avm3633, Basic care pack avm3757 BRAHMS PAPP-A Kryptor Lots 566034 and 566036 Ergolet Luna Track Hoist Handset Sidhil Universal Standard and High Siderails R82 X-Panda size 2 High-Low Frame Spacelabs Healthcare Ultraview SL Command Module (Model 90496 and 91496)
FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA Boston Scientific Hong Kong Ltd MHRA MHRA MHRA MHRA FDA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA FDA
Z-2336-2008 Z-2444-2008 Z-2339-2008 Z-2370-2008 to Z-2373-2008 Z-2389-2008 Z-2396-2008 to Z-2398-2008 Z-2434-2008 Z-2407-2008 to Z-2414-2008 Z-2406-2008 Z-2405-2008 Z-2459-2008 N/A 2008/010/002/061/003 2008/010/014/601/001 2008/010/016/061/016 2008/008/018/301/001 N/A 2008/010/010/061/012 2008/010/006/061/011 2008/010/014/061/023 2008/010/022/061/008 2008/010/013/601/004 2008/010/010/061/011 2008/010/009/061/007 2008/010/015/061/013 2008/010/009/061/028 2008/010/023/061/015 2008/009/026/601/002 2008/010/010/061/007 2008/004/004/401/002 2008/008/018/401/004 2008/004/025/401/012 Z-2342-2008 to Z-2343-2008
Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Firm Initiated Field Action FSCA FSCA FSCA FSCA Press Release FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA Class II
27-Oct-08 27-Oct-08 27-Oct-08 27-Oct-08 27-Oct-08 27-Oct-08 27-Oct-08 27-Oct-08 27-Oct-08 27-Oct-08 27-Oct-08 27-Oct-08 27-Oct-08 27-Oct-08 27-Oct-08 27-Oct-08 27-Oct-08 28-Oct-08 29-Oct-08 29-Oct-08 29-Oct-08 29-Oct-08 29-Oct-08 29-Oct-08 29-Oct-08 29-Oct-08 29-Oct-08 30-Oct-08 30-Oct-08 30-Oct-08 30-Oct-08 30-Oct-08 30-Oct-08
Philips Healthcare - Great China Zimmer PTE Ltd. (Hong Kong branch) N/A N/A Cardinal Health N/A Arjo Huntleigh (Hong Kong) Ltd B Braun Medical Hong Kong Pacific Medical (Hong Kong) Ltd. Beckman Coulter Hong Kong Ltd Cardinal Health Boston Scientific Hong Kong Ltd N/A GE Medical Systems Hong Kong Ltd. Medtronic International, Ltd. N/A N/A N/A N/A N/A N/A N/A N/A Stryker China Ltd Stryker China Ltd CELKI Medical Company Siemens Healthcare Diagnostic Limited N/A N/A N/A N/A N/A N/A
2821 5480 2992 0968 N/A N/A
N/A 2508 9553 2277 6125 2343 8009 2240 6150
2960 7136 N/A 2783 1838 2919 1300 N/A N/A N/A N/A N/A N/A N/A N/A 2518 6988 2518 6988 2810 7533 N/A N/A N/A N/A N/A N/A
Medical Device Control Office
41
Department of Health The Government of HKSAR
SN0810165 SN0810166 SN0810167 SN0810168 SN0810169
Zimmer Durom cup, Metasul Durom acetabular compenent Medtronic BI-700-00027 0-arm 1000 Imaging System mobile X-ray System Siemens Sonoline G50/G60 Ultrasound System (Software versions 1.0.0 to 1.5.0b) GE Precision MPi (Model 5126893 -, 2385125, 2398238) GE Healthcare Innova 2100IQ, 3100 IQ, 4100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and Vascular
FDA FDA FDA FDA FDA
Z-2415-2008 to Z-2426-2008 Z-2034-2008 Z-2468-2008 Z-2142-2008 to Z-2144-2008 Z-1518-2008 to Z-1520-2008
Class II Class II Class II Class II Class II
30-Oct-08 30-Oct-08 30-Oct-08 30-Oct-08 30-Oct-08
Zimmer PTE Ltd. (Hong Kong branch) Medtronic International, Ltd. Siemens Healthcare Diagnostic Limited GE Medical Systems Hong Kong Ltd. GE Medical Systems Hong Kong Ltd.
2992 0968 2907 5911 2810 7533 2783 1838 2783 1838
Medical Device Control Office
42
Department of Health The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - September 2008
Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. Description of Product No. SN080901 SN080902 SN080903 SN080904 SN080905 SN080906 SN080907 SN080908 SN080909 SN080910 SN080911 SN080912 SN080913 SN080914 SN080915 SN080916 SN080917 SN080918 SN080919 SN080920 SN080921 SN080922 SN080923 Invacare Reliant 100 / 150 / 200 / 250 Sybron Pitt Easy implants Liftech Gemini Ceiling Track Hoist Boston Scientific Platinum PlusT Guidewire (Peripheral) Medtronic Adjustable Valve Model 6248VAL and Attain 6216A and 6218A System Kits Physio Control LIFEPAK CR Plus Ev3 Primus GPS Biliary Stent Systems (Ref: BXB35-08-37-75) Ev3 Protege GPS Biliary Stent Systems (Ref: SERB65-06-60-120) Arjo Nautica (GK) Mattress Stretcher Smiths Medical CADD-MS"3 Ambulatory Infusion Pumps (Model 7400, Rx only) Philips Medical General X-Ray System types with Digital Spot Imaging (DSI) software (Software version: rel 6) Stryker Stem Trial, Triathlon Revision Instruments Stryker Xcelerate Patella System Reamer Shaft Assembly (Product no.: 8001-1702) Medtronic Midas Rex Legend tapered dissecting tool (Model F2/8TA23) Medtronic Physio Control, FASTPAK batteries GE Healthcare Corometrics Model 250 series Maternal/ Fetal Monitor (Models 256 and 259, part no 2024489-002) GE Healthcare Precision RXi 23A/32A Remote X-Ray Imaging R&F System Siemens Medical Syn go Imaging XS (Model no 7502029) Hill-Rom Century+ Bed (Model P1400 HBSM siderail upgrade kits) Bisco BISCEM Dual-Cured Self-Adhesive Resin Cement Acumed 3.5mm x 32.5mm Cortical Screw used with the Polarus Humeral Fixation System Pacific Consolidated Industries Mobile Oxygen Storage Tank, MOST 20-2B (Part no 793080-002) Pride Mobility Q-Logic Controller Software Source of Information MHRA MHRA MHRA Boston Scientific Hong Kong Ltd Medtronic International Ltd Medtronic International Ltd FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA Reference No. by Source 2008/001/008/401/008 2008/008/019/061/013 2008/006/011/291/006 N/A N/A N/A Z-2170-2008 Z-2169-2008 Z-1234-2008 Z-1641-2008 Z-2160-2008 Z-2157-2008 to Z-2158-2008 Z-1778-2008 Z-2156-2008 Z-1567-2008 Z-2154-2008 Z-1563-2008 to Z-1565-2008 Z-1643-2008 Z-1777-2008 Z-1696-2008 to Z-1697-2008 Z-2155-2008 Z-2201-2008 Z-1776-2008 Alert Type by Source FSCA FSCA FSCA Firm Initiated Field Action Firm Initiated Field Action Firm Initiated Field Action Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Date of Issue (YYYY/MM/DD) 2008/09/02 2008/09/02 2008/09/02 2008/09/03 2008/09/03 2008/09/03 2008/09/04 2008/09/04 2008/09/04 2008/09/04 2008/09/04 2008/09/04 2008/09/04 2008/09/04 2008/09/04 2008/09/04 2008/09/04 2008/09/04 2008/09/04 2008/09/04 2008/09/04 2008/09/04 2008/09/04 Local Agent N/A N/A N/A Boston Scientific HK Limited Medtronic International, Ltd. Medtronic International, Ltd. N/A N/A Arjo Huntleigh (Hong Kong) Ltd Goodman Medical Supplies Ltd Philips Healthcare - Great China Stryker China Ltd Stryker China Ltd Medtronic International, Ltd. Medtronic International, Ltd. GE Medical Systems Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. Siemens Ltd. N/A N/A N/A N/A N/A Agent Contact Telephone No N/A N/A N/A 2960 7136 2907 5911 2907 5911 N/A N/A 2508 9553 2332 4455 2821 5480 2518 6988 2518 6988 2907 5911 2907 5911 2783 1838 2783 1838 2810 7533 N/A N/A N/A N/A N/A
Medical Device Control Office
43
Department of Health The Government of HKSAR
SN080924 SN080925 SN080926 SN080927 SN080928 SN080929 SN080930 SN080931 SN080932 SN080933 SN080934 SN080935 SN080936 SN080937 SN080938 SN080939 SN080940 SN080941 SN080942 SN080943 SN080944 SN080945 SN080946 SN080947 SN080948 SN080949 SN080950 SN080951
Bostson Scientific Smash Balloon Dilatation Catheter Genzyme Seprafilm Adhesion Barrier (Product Number: 4301-02 and 4301-05) Sunrise Medical Quickie Rhythm Power Wheelchair with QC (nonexpandable) electronics (Model no. EIPW10 and EIPW13) Caire Generation 4 electronic liquid gauges Huntleigh Healthcare Maxisky 600 Peacocks Medical Fitzyou Moulded Wheelchair seat Systems Invacare Scanbed SB750 Abbott Universal Clamp Reduction Tool GE Healthcare Signa HDx Scanner Intersurgical Solus Laryngeal Mask Airway Johnson and Johnson Cordis LuMend Outback Re-entry catheter Bausch & Lomb AMVISC and AMVISC PLUS - Viscoelastic (Ref: DV-2007-8041) Innovacon Prostate Specific Antigen Drager Primus, Apollo, Pallas Devices STERIS 20 Sterilant Concentrate Gambro SteriChek Sensitive Total Chlorine Reagent Strips Medtronic Neurostimulator programmers Edwards Lifesciences Ascendra Balloon Catheter Sirona type B, VS and S Siroclaves and Siromini Boston Scientific ALTRUA® Implantable Pacemaker GE Precision 500D Classical Radiographic-Fluoroscopic X-Ray System (Model# 2289299-2) Abbott InCompass Spinal Fixation System T-Handle Driver and PathFinder Spinal Fixation System T-Handle Driver Otsuka UBiT®-IR300 Infrared Spectrophotometer, software versions 7.0, 7.01 and 7.11 Invivo Lithium Polymer Wireless Module Batteries Teleflex Weck Clips products : Hemolok clips, Horizon Clips and Hemoclip Vital Signs Light Wand Orotracheal Lighted Stylet Cook Zenith AAA Stent-Graft Philips Healthcare iSite PACS
Boston Scientific Hong Kong Ltd FDA FDA FDA MHRA MHRA MHRA MHRA MHRA MHRA MHRA Bausch & Lomb (Hong Kong) Limited MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA FDA FDA FDA Goodwin Health Care Ltd Solar-med Limited MHRA MHRA MHRA
N/A Z-1647-2008 to Z-1648-2008 Z-1531-2008 to Z-1532-2008 Z-1716-2008 2007/010/018/401/014 2007/010/016/261/001 2007/011/015/061/004 2008/008/014/061/004 2008/008/027/061/019 2008/008/027/061/028 2008/008/021/061/008 N/A 2008/008/029/061/022 2008/008/029/061/020 2008/007/015/401/008 2008/008/012/061/011 MDA/2008/065 2008/008/027/061/007 2008/009/002/061/004 2008/009/003/061/007 Z-0369-2008 Z-1592-2008 to Z-1593-2008 Z-1749-2008 N/A N/A 2008/008/028/061/002 2006/005/017/401/009 2008/008/026/061/019
Firm Initiated Field Action Class II Class II Class II FSCA FSCA FSCA FSCA FSCA FSCA FSCA Firm Initiated Field Action FSCA FSCA FSCA FSCA MDA FSCA FSCA FSCA Class II Class II Class II Firm Initiated Field Action Firm Initiated Field Action FSCA FSCA FSCA
2008/09/05 2008/09/08 2008/09/08 2008/09/08 2008/09/08 2008/09/08 2008/09/08 2008/09/09 2008/09/09 2008/09/09 2008/09/09 2008/09/10 2008/09/10 2008/09/10 2008/09/10 2008/09/11 2008/09/12 2008/09/12 2008/09/12 2008/09/12 2008/09/12 2008/09/12 2008/09/12 2008/09/12 2008/09/12 2008/09/16 2008/09/16 2008/09/16
Boston Scientific HK Limited Genzyme Asia Limited N/A N/A N/A N/A N/A Abbott Laboratories Ltd. GE Medical Systems HK Ltd N/A Johnson & Johnson Medical (HK) Bausch & Lomb (Hong Kong ) Ltd N/A Draeger Medical Hong Kong Ltd. Swedish Trading Co. Ltd. Gambro Hong Kong Limited Medtronic International, Ltd. N/A N/A Boston Scientific HK Limited GE Healthcare Abbott Laboratories Ltd. Otsuka Pharmaceutical (HK) Ltd Goodwin Health Care Ltd Solar-med Limited N/A Cook Asia Ltd Philips Healthcare - Great China
2960 7136 2810 1613 N/A N/A N/A N/A N/A 2806 4021 2783 1838 N/A 2738 6027 2213 3371 N/A 2877 3077 N/A N/A 2907 5911 N/A N/A 2960 7136 2609 9233 2806 4021 2881 6299 N/A 2425 0926 N/A N/A 2821 5480
Medical Device Control Office
44
Department of Health The Government of HKSAR
SN080952 SN080953 SN080954 SN080955 SN080956 SN080957 SN080958 SN080959 SN080960 SN080961 SN080962 SN080963 SN080964 SN080965 SN080966 SN080967 SN080968 SN080969 SN080970 SN080971 SN080972 SN080973 SN080974 SN080975 SN080976 SN080977 SN080978
ThermoFisher BO0366D Brain Heart Infusion R82 A/S Hip Belt Philips Healthcare HDI4000 Diagnostic Ultrasound System Philips Healthcare HD3 Diagnostic Ultrasound System BD FACSAria Sorters running BD FACSDiva Software, version 3.0 or later Johnson and Johnson ASP Automatic Endoscope Reprocessor (AER) Boston Scientific iLabR Ultrasound Imaging Systems GE Healthcare Responder 2000 Defibrillator Stryker Orthopaedics Kinemax Plus Revision TS Tibial Inserts Philips Healthcare BV Pulsera and Endura Abbott AGA Medical Corporation AMPLATZER Delivery System (REF 9-DEL-10F-45/80) and AMPLATZER Sizing Balloon II (REF 9SB 24) Abbott Free Style Blood Glucose Monitoring System Test Strips Abbott PathFinder Cannulated T-Handle Bone Awl (Part No. 1155-2) GE Datex-Ohmeda Neonatal Enhancement for the Engstrom Carestation (Model# 1505-3272-00) GE Centricity AW Suite 2.0 Software running on the Centricity RA 1000 or RA600/CA1000 Workstation Medtronic CD Horizon Agile Dynamic Stabilization Device Medtronic Physio-Control LIFEPAK 20 and LIFEPAK 20e Difibrillator/monitor Medtronic Suction Jar Lid for Medela Vario 18 Vacuum Pump GE 1.5 T and 3.0 T Signa HDX MR System Model No. 2226300, 2377062-61, 2395001, 2395001-2, 5107849 and 5127452 Siemens Linear Medical Accelerators equipped with COHERENCE Therapist R2.1 and Primeview 3 i R 2.1 Siemens SIMIVIEW 3000, SIMVIEW NT and MEV ASIM S systems (Instructions" TH003/08/S" update) Stryker Scorpio Total Knee Posteriorly Stabilized Femoral Component #7R and #7l (Catalog # 71-4107R and 71-4506L) Stryker Gamma3 System Set Screwdriver, Flexible Shaft and Gammas Set Screwdriver Instrument Set, Orthopedic Device Stryker Digital System Ultra (SDC Ultra) (Model no.: 240-050-988) Covidien/Mallinckrodt CT9000/ CT9000ADV (Model no.: 241300) Biomet EZLoc 7-8mm TM Femoral Fixation (Catalog No 904780) Biomet Orthopedics Echo Hip Instrumentation Exact Slotted Stem Inserter (Part number 31-555610)
MHRA MHRA MHRA MHRA BD Asia Ltd (Hong Kong) Johnson & Johnson Medical Hong Kong Boston Scientific Hong Kong Ltd MHRA MHRA MHRA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA
2008/009/002/601/004 2008/009/005/061/006 2008/009/010/061/004 2008/009/010/061/010 N/A N/A N/A 2008/008/013/061/012 MDA/2008/066 2008/009/010/061/008 Z-2192-2008 to Z-2193-2008 Z-1813-2008 Z-1784-2008 Z-1526-2008 Z-1825-2008 Z-1408-2008 to Z-1441-2008 Z-2009-2008 to Z-2011-2008 Z-2168-2008 Z-2225-2008 Z-1768-2008 Z-2196-2008 Z-1814-2008 Z-1626-2008 to Z-1627-2008 Z-1316-2008 Z-1828-2008 Z-1782-2008 Z-1318-2008
FSCA FSCA FSCA FSCA Firm Initiated Field Action Firm Initiated Field Action Firm Initiated Field Action FSCA MDA FSCA Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II
2008/09/16 2008/09/16 2008/09/16 2008/09/16 2008/09/16 2008/09/16 2008/09/17 2008/09/18 2008/09/19 2008/09/19 2008/09/19 2008/09/19 2008/09/19 2008/09/19 2008/09/19 2008/09/19 2008/09/19 2008/09/19 2008/09/19 2008/09/19 2008/09/19 2008/09/19 2008/09/19 2008/09/19 2008/09/19 2008/09/19 2008/09/19
N/A N/A Philips Healthcare - Great China Philips Healthcare - Great China BD Asia Ltd (Hong Kong) Johnson & Johnson Medical (HK) Boston Scientific HK Limited GE Medical Systems HK Ltd Stryker China Limited Philips Healthcare - Great China Abbott Laboratories Ltd. Abbott Laboratories Ltd. Abbott Laboratories Ltd. GE Medical Systems Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. Medtronic International, Ltd. Medtronic International, Ltd. Medtronic International, Ltd. GE Medical Systems Hong Kong Ltd. Siemens Ltd. Siemens Ltd. Stryker China Ltd Stryker China Ltd Stryker China Ltd COVIDIEN N/A N/A
N/A N/A 2821 5480 2821 5480 2575 8668 2738 6027 2960 7136 2783 1838 2518 6988 2821 5480 2806 4021 2806 4021 2806 4021 2783 1838 2783 1838 2907 5911 2907 5911 2907 5911 2783 1838 2810 7533 2810 7533 2518 6988 2518 6988 2518 6988 3157 7220 N/A N/A
Medical Device Control Office
45
Department of Health The Government of HKSAR
SN080979 SN080980 SN080981 SN080982 SN080983 SN080984 SN080985 SN080986 SN080987
Varian Medical Varis Aria Radiation Oncology Version 8.1 Telefex Weck - DuraHook (Catalog #382800, 382805) AGFA IMPAX 6.2.1 System (PAC) AGFA IMPAX 4.1 and WEB1000 Versions 3.1 Baxter Healthcare (Edwards Lifesciences LLC) Fem-Flex II Femoral Venous Cannula and Fem-Flex II Duraflo Treated Femoral Venous Catheter Bio-Rad VARIANT -thalassemia Short Program Hemoglobin Testing System(Model 270-0019 and 270-0002) Allez Spine Laguna Pedicle Screw System (IT-FN1001 and ITFN1007) Galil Medical Warming Catheter Resonance Technology Headset Model no RTC-2K and RTC-551070 BD Vacutainer 16 x 100 MM Serum Blood Collection tubes, BD Vacutainer 16 x 100 mm SSTII Advance Blood Collection tubes, BD Vacutainer 16 x 100 Glass Calcium Chloride Blood Collection tubes (FA 08002) MIM 4.0 and MIM 4.1 Merit Medical Systems Fluid Administration Set, Custom Kit Mentor Psi-Tec Tubing, Autofuse Tubing, i-Vac Tubing, Lamis Tubing Set, Y Tubing Set, Irrigation Tubing, Psi-Tec SYRINGE Pump Infiltration Tubing, Contour Genesis Infiltration Tubing, Contour Geneses Inf/IR Tubing AND Contour Genesis Aspiration Tubing Encore Medical Keramos Replacement Polyethlene Liner Orthodocs Cocoon Pride Mobility Quantum Vibe Power Chair Philips BV Pulsera and Endura, C-arm Beckman Coulter Access Immunoassay Systems HAV Ab Reagent Kit Tyco Healthcare Hot/Cold Pack Various Hot/Cold Gel Pack GE 1.5T and 3.0T Sigma HDx System and GE Signa Excite 1.5T MR and 3.0T MR System Philips Gallileo Automatic Collimator (Part Number 9896 010 00612, 9896 010 00614, 9896 010 00615) Philips OmniDiagnost Eleva X-Ray System Hitachi Altaire MRI System Emergency Rundown Switch Unit (ERDU) Stryker OmniFit X-Ray Templates and OmniFit HFx Sell Sheets Stryker Triathlon Femoral Sizer Stryker Short Barrel Sideplate (Catalog no. 3362-0-404) Stryker Ureteral Kit (Model no.: 220-180-516) and Stryker Ureteral Universal Kit (Model no.: 220-180-517)
FDA FDA FDA FDA FDA FDA FDA FDA FDA BD Asia Ltd (Hong Kong) FDA FDA
Z-2194-2008 Z-1856-2008 to Z-1857-2008 Z-1245-2008 Z-1243-2008 to Z-1244-2008 Z-1893-2008 to Z-1894-2008 Z-1588-2008 to Z-1589-2008 Z-1819-2008 to Z-1820-2008 Z-1698-2008 Z-1823-2008 to Z-1824-2008
Class II Class II Class II Class II Class II Class II Class II Class II Class II Firm Initiated Field Action Class II Class II
2008/09/19 2008/09/19 2008/09/19 2008/09/19 2008/09/19 2008/09/19 2008/09/19 2008/09/19 2008/09/19
Varian Medical Systems Pacific Inc. Solar-med Limited AGFA Hong Kong Limited AGFA Hong Kong Limited Baxter Healthcare Ltd Bio-Rad Pacific Ltd. N/A N/A N/A
2724 2836 2425 0926 2555 9421 2555 9421 2807 8500 2789 3300 N/A N/A N/A
SN080988 SN080989 SN080990
N/A Z-1827-2008 Z-1800-2008 to Z-1807-2008
2008/09/22 2008/09/22 2008/09/22
BD Asia Ltd (Hong Kong) N/A N/A
2575 8668 N/A N/A
SN080991
FDA
Z-1790-2008 to Z-1799-2008
Class II
2008/09/22
N/A
N/A
SN080992 SN080993 SN080994 SN080995 SN080996 SN080997 SN080998 SN080999 SN081000 SN081001 SN081002 SN081003 SN081004 SN081005 SN081006
FDA MHRA MHRA MHRA MHRA TGA TGA FDA FDA FDA FDA FDA FDA FDA FDA
Z-1785-2008 2008/006/006/401/006 2008/005/014/301/003 2008/009/011/061/008 2008/009/011/601/601/002 N/A N/A Z-1890-2008 to Z-1891-2008 Z-1886-2008 Z-1374-2008 Z-1542-2008 Z-2054-2008 to Z-2055-2008 Z-1864-2008 Z-2865-2008 Z-1866-2008 to Z-1867-2008
Class II FSCA FSCA FSCA FSCA N/A N/A Class II Class II Class II Class II Class II Class II Class II Class II
2008/09/22 2008/09/24 2008/09/24 2008/09/24 2008/09/24 2008/09/24 2008/09/25 2008/09/26 2008/09/26 2008/09/26 2008/09/26 2008/09/26 2008/09/26 2008/09/26 2008/09/26
N/A N/A N/A Philips Healthcare - Great China Beckman Coulter Hong Kong Ltd COVIDIEN N/A GE Medical Systems Hong Kong Ltd. Philips Healthcare - Great China Philips Healthcare - Great China N/A Stryker China Ltd Stryker China Ltd Stryker China Ltd Stryker China Ltd
N/A N/A N/A 2821 5480 2240 6150 3157 7220 N/A 2783 1838 2821 5480 2821 5480 N/A 2518 6988 2518 6988 2518 6988 2518 6988
Medical Device Control Office
46
Department of Health The Government of HKSAR
SN081007 SN081008 SN081009 SN081010 SN081011 SN081012 SN081013 SN081014 SN081015 SN081016 SN081017 SN081018 SN081019 SN081020 SN081021 SN081022 SN081023 SN081024 SN081025 SN081026 SN081027 SN081028 SN081029 SN081030 SN081031 SN081032 SN081033 SN081034 SN081035 SN081036
Zimmer 4.5 Compression plate-broad (REF 4945-10-01) Medtronic Physio-Control Internal Defibrillator Handles and Internal Defibrillation Electrodes Medtronic VNUS Medical U-CLIP Remocal Tool (UREM 1860) Johnson and Johnson Depuy LCS Knee Merit Fountain Indusion System, 4F (REF IS4-90-50) I-Flow On-Q C-bloc 400ml (REF CB005) I-Flow ON-Q PainBuster Infusion Pump (REF PS6504, Part No. 5001260) Intuitive Surgical da Vinvi S Surgical System (Model no IS2000) Intuitive Surgical DA Vinci Surgical System Model S Cardiac Probe Gasper Instrument (Model IS2000) Cooper Surgical M-Style Mushroom Cup Vacuum Assisted Delivery System, M-Style Cup with UVR and Mystic II M-Style Mushroom Cup Vacuum Assisted Delivery System Integra LifeSciences PANTA Nails Accuracy Cyberknife Robotic Radiosurgery System GMP LS-232 Large 12 LeadWear Single Pack and LS-202 Large LeadWear Combo Pack Diamedix Is-anti-Gliadin IgG Enzyme Immunoassay Test kit (Catalog no 720-800) Cardiac Science Electrode Adaptor Cable Quick-Combo System (Model 9055) Sun Biomedical VisuaLine Single Dip Oxycodone, VisuaLine Propoxyphene test system, VisuaLine Tricyclic Antidepressants Greiner Bio-One Vacuette, Plastic Cannula HOLDEX (Ref 450216) ICU Medical Hospira Intralock Lipid Compatible 3-Way Stopcock, Hospira Monitoring Kit (PA Line) and Left Heart Kit Philips Brilliance CT Big Bore System-Main Unit and Brilliance CT System (16P) Philips Diagnost 94, Diagnost 96 and Diagnost 97 Philips Brilliance 64 Slice CT System-Main Unit Philips Essenta DR Philips Isite Pacs Philips HDI 4000 System Siemens Angiostar; Multistar D, P; Bicor HS, HS-ACS; Coroskop HS, HS-ACS, HI-P, C and Neurostar Top Siemens Axiom Luminos TF GE Instatrak 3500 System Impac Medical Systems Sequencer (Model 40000-000000-RO) Zimmer Patient Helper Reinforced Overhead Bar Porex Surgical Ocular Conformers (Non-Vented and Vented)
FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada
Z-2179-2008 Z-2035-2008 to Z-2036-2008 Z-1609-2008 Z-1812-2008 Z-2107-2008 Z-2133-2008 Z-1869-2008 Z-2204-2008 Z-1811-2008 Z-1887-2008 to Z-1889-2008 Z-1877-2008 Z-1862-2008 Z-1659-2008 to Z-1660-2008 Z-1684-2008 Z-1714-2008 Z-1873-2008 to Z-1875-2008 Z-2134-2008 Z-2205-2008 to Z-2208-2008 43308 43340 43322 43360 43324 43395 43314 43288 42398 43446 43273 43459
Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II
2008/09/26 2008/09/26 2008/09/26 2008/09/26 2008/09/26 2008/09/26 2008/09/26 2008/09/26 2008/09/26 2008/09/26 2008/09/26 2008/09/26 2008/09/26 2008/09/26 2008/09/26 2008/09/26 2008/09/26 2008/09/26 2008/09/29 2008/09/29 2008/09/29 2008/09/29 2008/09/29 2008/09/29 2008/09/29 2008/09/29 2008/09/29 2008/09/29 2008/09/29 2008/09/29
Zimmer PTE Ltd. (Hong Kong branch) Medtronic International, Ltd. Medtronic International, Ltd. Johnson & Johnson Medical (HK) N/A N/A N/A N/A N/A N/A N/A Accuray Asia Ltd N/A N/A N/A N/A Mekim Ltd N/A Philips Healthcare - Great China Philips Healthcare - Great China Philips Healthcare - Great China Philips Healthcare - Great China Philips Healthcare - Great China Philips Healthcare - Great China Siemens Ltd. Siemens Ltd. GE Medical Systems Hong Kong Ltd. N/A Zimmer PTE Ltd. (Hong Kong branch) N/A
2992 0968 2907 5911 2907 5911 2738 6027 N/A N/A N/A N/A N/A N/A N/A 2247 8628 N/A N/A N/A N/A 2774 8300 N/A 2821 5480 2821 5480 2821 5480 2821 5480 2821 5480 2821 5480 2810 7533 2810 7533 2783 1838 N/A 2992 0968 N/A
Medical Device Control Office
47
Department of Health The Government of HKSAR
SN081037 SN081038 SN081039 SN081040 SN081041 SN081042 SN081043 SN081044 SN081045 SN081046 SN081047 SN081048 SN081049 SN081050 SN081051 SN081052 SN081053 SN081054 SN081055
Medilab Beautytek Premium Edition Home Telehealth WebVMC Remote Nurse Covidien Argyle Suction Catheter Bauerfeind AG Shin Tubes Mod. A3-Ti200/400 and A3-St200 B Braun Microspeed Uni Mobile stand GA411 Coloplast Folysil Xtra Silicone Indwelling Catheters Utah Intran Plus IUPC trays Siemens Medical Solutions Diagnostics Advia 120 & Advia 2120 Draeger Sub-Acute Care Ventilator Carina BD Visitec High Viscosity Injector Johnson and Johnson AnimasTM 2020 and IR 1200 Insulin Pump Sybron Endo K3 Engine File G-Pack Adac Laboratories Precedence System (6 and 16 Slice) Apogee Intermittent Catheter Medacta AMIS Universal Table for Leg Positioner (Model no. 01.15.10.0172) EBI Trauma Fixation Systems Biomet Hybrid Glenoid Boss Cutter; item 406150 Biomet OSS Interlok IM Stem Boston Scientific Precision Charger 1.0 (UPN M365SC53000)
Health Canada MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA Health Canada Health Canada Health Canada FDA FDA FDA FDA Boston Scientific Hong Kong Ltd
41783 2008/008/018/061/010 2008/007/029/061/011 2007/009/018/401/005 2008/009/022/061/003 2008/008/028/401/010 2008/009/016/051/001 2008/006/005/291/004 2008/007/003/401/011 2008/009/022/061/010 2008/009/022/061/015 43337 43306 43335 Z-1870-2008 Z-2012-2008 Z-1658-2008 Z-1879-2008 to Z-1881-2008 N/A
Type II FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA Type II Type II Type II Class II Class II Class II Class II Firm Initiated Field Action
2008/09/29 2008/09/29 2008/09/29 2008/09/29 2008/09/29 2008/09/29 2008/09/30 2008/09/30 2008/09/30 2008/09/30 2008/09/30 2008/09/30 2008/09/30 2008/09/30 2008/09/30 2008/09/30 2008/09/30 2008/09/30 2008/09/30
N/A N/A Covidien N/A B Braun Medical Hong Kong Coloplast (Hong Kong) Ltd N/A Siemens Ltd N/A BD Asia Ltd (Hong Kong) Johnson & Johnson Medical (HK) N/A N/A N/A N/A N/A N/A N/A Boston Scientific HK Limited
N/A N/A 2574 3251 N/A N/A N/A N/A 2810 7533 N/A 2722 5660 2738 6027 N/A N/A N/A N/A N/A N/A N/A 2960 7136
Medical Device Control Office
48
Department of Health The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - August 2008
Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. Description of Product No. SN080801 Bayer Ascensia Contour blood glucose meters SN080802 SN080803 SN080804 SN080805 SN080806 SN080807 SN080808 SN080809 SN080810 SN080811 SN080812 SN080813 Levitronix CentriMag Systems Stryker Scorpio Series 7000 Tibial Impactor/Extractor ThermoFisher Scientific BO0348V Maximum recovery diluent Baxter FLOSEAL Endoscopic Applicator (#1500181) Arjo Carendo multi-purpose hygiene chair CASMED 740 Series Multiparameter Monitor Siemens ADVIA Centaur CP immunoassay system TomoTherapyR Hi-Art Treatment System TomoTherapyR Hi-Art Treatment System GE Healthcare Centricity Perinatal (formerly QS) System - PFILS software GE Healthcare Precision 500D Classical R&F System with control room PC (Model no. 5117866-27) Intuitive Surgical Da Vinci S 8mm Instrument Cannula (Model IS2000, Part No. 400254-01, 400255-01) Synovis GEM 2753 Microvascular Anastomotic Coupler, 2.5mm (REF GEM2753/1, P/N 5111-00250-010) Varian Acuity with Conebeam COMPUTED Tomography (Model No. H77) Varian High-Definition 120 MultiLeaf Collimator (Product code: H56) Philips 1.5T Intera and 1.5T Achieva systems Biomet Pectus Table Top Bender (part # 01-3906) Johnson and Johnson Depu Delta XTEND Baxter COLLEAGUE Triple Channel Mono and CXE Volumetric Infusion Pumps Stille Sonesta 6210 fluoroscopy procedure table ThermoFisher EB0212E Cooked meat medium Regulatory Insight Rolling Walkers (Rollators) Maquet Servo-I (Model 640870800 E407E) Source of Information MHRA MHRA MHRA MHRA Baxter Healthcare Ltd MHRA MHRA MHRA MHRA MHRA FDA FDA Reference No. by Source MDA/2008/059 2008/002/026/401/001 2008/007/007/061/017 2008/007/018/601/501 N/A MDA/2008/060 2008/007/022/061/001 MDA/2008/061 2008/004/024/061/020 2008/004/024/061/021 Z-2037-2008 Z-0274-2008 Z-1348-2008 Alert Type by Source MDA FSCA FSCA FSCA Firm Initiated Field Action MDA FSCA MDA FSCA FSCA Class II Class II Class II Date of Issue (YYYY/MM/DD) 2008/08/01 2008/08/01 2008/08/01 2008/08/01 2008/08/04 2008/08/05 2008/08/05 2008/08/05 2008/08/05 2008/08/05 2008/08/07 2008/08/07 2008/08/07 Local Agent Bayer Healthcare N/A Stryker China Ltd N/A Baxter Healthcare Ltd N/A N/A N/A N/A N/A GE Medical Systems Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. N/A Agent Contact Telephone No 2814 4836 N/A 2518 6915 N/A 2807 8500 N/A N/A N/A N/A N/A 2783 1838 2783 1838 N/A
FDA
SN080814 SN080815 SN080816 SN080817 SN080818 SN080819 SN080820 SN080821 SN080822 SN080823 SN080824
FDA
Z-2138-2008 Z-1460-2008 Z-1459-2008 2008/007/022/051/005 2008/001/018/291/026 2008/007/023/061/004 2008/007/022/051/006 MDA/2008/063 2008/007/021/601/503 42905 43009
Class II Class II Class II FSCA FSCA FSCA FSCA MDA FSCA Type II Type II
2008/08/07 2008/08/07 2008/08/07 2008/08/08 2008/08/11 2008/08/11 2008/08/13 2008/08/13 2008/08/13 2008/08/13 2008/08/13
N/A Varian Medical Systems Pacific Inc. Varian Medical Systems Pacific Inc. Philips Medical System N/A Johnson & Johnson Medical Hong Kong N/A N/A N/A N/A Maquet Hong Kong Ltd
N/A 2724 2836 2724 2836 2876 7525 N/A 2738 2818 N/A N/A N/A N/A 2393 9511
FDA FDA MHRA MHRA MHRA MHRA MHRA MHRA Health Canada Health Canada
Medical Device Control Office
49
Department of Health The Government of HKSAR
SN080825 SN080826 SN080827 SN080828 SN080829 SN080830 SN080831 SN080832 SN080833 SN080834 SN080835 SN080836 SN080837 SN080838 SN080839 SN080840 SN080841 SN080842 SN080843 SN080844 SN080845 SN080846 SN080847 SN080848 SN080849 SN080850 SN080851
Teleflex Medical A) Dermahook Neuro Elastic Retractors 1/2", B) Dermahook Neuro Elastic Retractors 1/4" Hologic A) Delphi Bone Densitometer, B) Discovery QDR Bone Denositometer, C) Explorer QDR Bone Densitometer, D) QDR 4500 Bone Densitometer Acist Angiographic System - Table Kit Brainlab AG Brainscan Treatment Planning Software Philips A) PCR AC-500/PCR-5000, B) PCR Corado Eleva, C)PCR Compano System / PCR Eleva S Plus Philips Digital Diagnost Draeger Fabius Titro Anesthesia System Hospira LifeCare PCA Label Utilility, Version 1.0 CD Beckman Coulter Cytomics FC 500 Flow Cytometry System with Data Innovations Instrument Manager (Part no 626553 and 6605628) 3M Comply EO Chemical indicators Strips (Catalog # 1251) Johnson and Johnson Medical Advanced Sterilization Products EvoTech Endoscope Cleaner & Reprocessor (Product Code 50004 AND 50004-002) Siemens IMMULITE / IMMULITE 1000 Progesterone Homecraft Rolyan Savanah Raised Toilet Seat Brackets Stryker REDUCTION SPOON 09MM Activate Patron Bohemia Strollers Sunrise Medical Lomax Kid Active Recliner Attendant Push Wheelchairs Apline Microtargeting Electrode Cable Varian Exact Couch Pinch Point GE Healthcare Solar 8000/i/M Ortho Europe Uniaxial Foot Philips MRI Magnet Venting System Inspection ConMed Frazier and Poole Suction Instruments Medi-Plinth Three function electric foot switches Siemens Magnetom Mobile Systems KCI 500 ml Canister for Infovac Lomax Mobility Wheelchairs Medtronic MaximoR II Device
Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada FDA FDA FDA
42249 43205 43028 42381 43176 43190 43160 Z-1181-2008 Z-1529-2008 Z-1568-2008 Z-1368-2008 to Z-1369-2008 2008/007/025/061/020 2008/003/006/401/011 2008/007/023/061/010 2006/010/011/081/003 2008/001/003/061/022 N/A N/A 2008/007/024/601/510 2008/002/026/061/008 2008/007/023/061/006 2008/007/015/061/018 2008/005/008/401/005 2008/007/031/061/014 2008/007/031/061/003 2006/007/019/081/009 2008/007/021/401/014
Type II Type II Type II Type II Type II Type II Type II Class II Class II Class II Class II FSCA FSCA FSCA FSCA FSCA Firm Initiated Field Action Firm Initiated Field Action FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA
2008/08/13 2008/08/13 2008/08/13 2008/08/13 2008/08/13 2008/08/13 2008/08/13 2008/08/14 2008/08/14 2008/08/14 2008/08/14 2008/08/14 2008/08/14 2008/08/14 2008/08/14 2008/08/15 2008/08/15 2008/08/15 2008/08/18 2008/08/18 2008/08/18 2008/08/18 2008/08/18 2008/08/19 2008/08/19 2008/08/19 2008/08/19
N/A N/A Pacific Medical (Hong Kong) Ltd. N/A Philips Medical System Philips Medical System Draeger Medical Hong Kong Ltd. Hospira Ltd Beckman Coulter Hong Kong Ltd 3M Hong Kong Ltd Johnson & Johnson Medical Hong Kong Siemens Ltd. N/A Stryker China Ltd N/A N/A N/A Varian Medical Systems Pacific Inc. GE Medical Systems Hong Kong Ltd. N/A Philips Medical System N/A N/A Siemens Ltd. N/A N/A Medtronic International Limited
N/A N/A 2343 8009 N/A 2876 7525 2876 7525 2877 3077 2285 8382 2240 6150 2806 6314 2738 2818 2810 7533 N/A 2518 6915 N/A N/A N/A 2722 8123 2783 1838 N/A 2876 7525 N/A N/A 2810 7533 N/A N/A 2919 1300
FDA MHRA MHRA MHRA MHRA MHRA Apline BioMed Varian Medical Systems Pacific Inc. MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA
Medical Device Control Office
50
Department of Health The Government of HKSAR
SN080852 SN080853 SN080854 SN080855 SN080856 SN080857 SN080858 SN080859 SN080860 SN080861 SN080862 SN080863 SN080864 SN080865 SN080866 SN080867 SN080868 SN080869 SN080870 SN080871 SN080872 SN080873 SN080874 SN080875 SN080876 SN080877 SN080878 SN080879 SN080880 SN080881
Roche Diagnostics modular analytics Edwards Lifescience Accusol 35 Harmofialysis solutions for Acute Renal Therapy Chiron PROCLEIX (Assay Reagent) ArthroCare Topaz XL ArthroWand MedtronicLIFEPAK CR Plus and LIFEPAK Express Defibrillator Smiths Medical CADD-MS 3 Ambulatory Infusion Pimp (Model 7400) Philips Medical Systems iSite PACS version 3.6.28.0 and version 4.1.17.0 Varian Medical Systems On-Board Imager, versions 1.0.15 and 1.2.05 Imaging Accessory to Medical Linear Accelerator BD FACSDiva Software Versions 4.0.1 to 5.0.2 Flow Cytometry Acquistion & Analysis software (Catalog no 641609) BD Difco(tm) Shigella Antiserum Poly Group B (Catalog no. 228351 and 210722) Atrium Medical HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip GE Datex-Ohmeda Neonatal Enhancement for the Engstrom Carestation (Model# 1505-3272-00) Impac Medical Systems SEQUENCER, MOSAIQ versions 1.3 and 1.4 (Model # 40003-001000-RO) Medtronic PROSTIVAR RF Model 8929 Hand Piece BrainlabVectorVision Sky and/or BrainSUITE NET system Varian Exact Couch with Exact Couch Top Maquet Expiratory Valve Coils GE Healthcare CT/SPECT Studies of Brain Scans Altomed Irrigating handpiece A3404 B Braun Prevision Implant System GE Healthcare CT/SPECT Studies of Brain Scans Cook Endoureterotomy Stent Set Apex TS 1211/1311 Combo Unit Impac Medical Systems SEQUENCER (Model: 50200-000000-RO) Dentsply Osteograf N-300 (Model: 930000-304) Dentsply Lexicon size 15 dental hand files Synthes Labelling for Synthes Power Drive (Model: 530.1) BD BBL Staphyoside Test (Model: 240952, 240953) Tyco Argyle Suction Catheter (Model: 1180-851121, 1180-851147) Philips Allura XPER FD10, Allura XPER FD 20 system, Allura XPER FD 20/10 System, Integris Allura, Integris H5000F Cardiology Imaging System
MHRA Health Canada Press MHRA MHRA FDA FDA FDA FDA FDA FDA FDA FDA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada
2008/007/011/061/012 N/A N/A 2008/008/001/061/001 2008/008/004/051/010 Z-1621-2008 Z-1443-2008 to Z-1444-2008 Z-1442-2008 Z-1525-2008 Z-1527-2008 to Z-1528-2008 Z-1830-2008 to Z-1853-2008 Z-1526-2008 Z-1515-2008 2008/008/006/061/010 2008/008/004/051/009 2008/008/007/061/015 2008/007/016/061/004 2008/008/011/051/011 2008/008/005/051/002 2008/008/004/061/010 2008/008/011/051/011 2008/007/021/061/001 41710 33877 41213 40992 43294 41510 43260 43276
FSCA N/A N/A FSCA FSCA Class II Class II Class II Class II Class II Class II Class II Class II FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA Type II Type I Type II Type II Type II Type II Type II Type II
2008/08/20 2008/08/20 2008/08/21 2008/08/21 2008/08/21 2008/08/21 2008/08/21 2008/08/21 2008/08/21 2008/08/21 2008/08/21 2008/08/21 2008/08/21 2008/08/25 2008/08/25 2008/08/25 2008/08/25 2008/08/25 2008/08/25 2008/08/25 2008/08/25 2008/08/25 2008/08/27 2008/08/27 2008/08/27 2008/08/27 2008/08/27 2008/08/27 2008/08/27 2008/08/27
Roche Diagnotics (Hong Kong) Ltd. Baxter Healthcare Ltd Chiron Limited N/A Medtronic International Limited Goodman Medical Supplies Ltd Philips Medical Systems Varian Medical Systems Pacific Inc. BD Asia Ltd (Hong Kong) BD Asia Ltd (Hong Kong) N/A GE Medical Systems Hong Kong Ltd. N/A Medtronic International Limited BrainLAB Ltd. (Hong Kong) Varian Medical Systems Pacific Inc. Maquet Hong Kong Ltd GE Medical Systems Hong Kong Ltd. N/A B Braun Medical Hong Kong GE Medical Systems HK Ltd Cook Asia Ltd. N/A N/A N/A N/A N/A BD Asia Ltd (Hong Kong) Tyco Healthcare (HKSAR) LTD Philips Medical System
2485 7510 2807 8500 2161 3104 N/A 2919 1300 2332 4455 2821 5480 2722 8123 2722 5660 2722 5660 N/A 2783 1838 N/A 2919 1300
2722 8123 2393 9511 2783 1838 N/A N/A 2783 1838 N/A N/A N/A N/A N/A N/A 2575 8668 2574 3251 2876 7525
Medical Device Control Office
51
Department of Health The Government of HKSAR
SN080882 SN080883 SN080884 SN080885 SN080886 SN080887 SN080888 SN080889 SN080890 SN080891 SN080892 SN080893 SN080894 SN080895 SN080896 SN080897 SN080898 SN080899 SN080900 SN080901 SN080902 SN080903 SN080904 SN080905 SN080906 SN080907 SN080908 SN080909 SN080910 SN080911 SN080912
Philips Achieva 1.5T MRI System - Sense Torso Coil, Intera 1.5T MRI System - Sense XL Torso Coil Siemens MicroScanR Dried Overnight Gram Negative and Synergies plusR Negative Panels Johnson and Johnson Vicryl Rapide Medtronic Deep Brain Stimulator lead kit with cap Molnlycke ProcedurePak Beckman Coulter Access Power Supply Assembly Seld (Part No.: A48196/6845C) Boston Scientific VITALITY DR+ ICD (model 1872) and VITALITY EL (models T127, T167, T177) ICD Abbott CELL-DYN Sapphire Hematology Analyzer (List No. 08H0001) Mallinckrodt OptiVantage DH Injection System (Catalog# V8400, Part no. 241078 & Catalog# V8402, Part # 241079) Stryker Omnifit EON Surgical Protocol Stryker Radius Rod Persuader and Radius Capsin (Catalog # 486619190, 486619210) Siemens Medical charged-particle radiation therapy system Biomet Modular Microplasty Cup Inserter and Impactor Bio-Rad MONOLISA Anti-HBc EIA (Catalog no 26186) GIVEN Diagnostic System with PillCam SB Capsule AMO Excimer Laser System Medline Bariatric Wheelchair EKOS EndoWave Infusion System Acumed Osteo-Clage Cable System Package Assembly (01-0001-S) StatSampler 200 uL, Li Heparin (Ref: SS2H) Philips HeartStart MRx Monitor/Defibrillator Smith & Nephew Dyonics 25 Tubeset kits Siemens Trugene HIV-1 Module for GuideLines Rules 11.0, 12.0 & 13.0 Sorin D901 Lilliput 1/ D100 Dideco Kids Medtronic Disposable Magellan Kits and One Source Kits Baxter HOMECHOICE/HOMECHOICE PRO Automated Peritoneal Dialysis System Leckey Squiggles Stander on Pivot Chassis Philips Allura Xper FD10 and FD10/10 GE Voluson E8 Ultrasound Systems BrainlabExac TRac Infrared Tracking Platform 5.0, 5.5 Baylis Medical Toronto Transseptal Catheter Model TSC-50-75
Health Canada MHRA MHRA MHRA MHRA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA
43296 2008/008/013/061/009 2008/008/011/061/007 2008/008/015/061/004 2008/007/023/061/008 Z-1183-2008 Z-1513-2008 to Z-1514-2008 Z-2139-2008 Z-1694-2008 Z-1750-2008 Z-1377-2008 to Z-1378-2008 Z-1769-2008 Z-1185-2008 to Z-1187-2008 Z-1189-2008 Z-1447-2008 Z-1695-2008 Z-1770-2008 to Z-1772-2008 Z-1773-2008 Z-2140-2008 Z-2234-2008 2008/008/018/061/026 2008/008/015/061/007 2008/008/018/061/021 2008/008/020/061/006 2008/008/021/061/010 2008/005/028/061/023 2008/005/008/401/003 2008/007/002/061/011 2008/005/019/601/350 2008/008/011/061/001 2008/008/021/061/001
Type II FSCA FSCA FSCA FSCA Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA
2008/08/27 2008/08/27 2008/08/27 2008/08/27 2008/08/27 2008/08/28 2008/08/28 2008/08/28 2008/08/28 2008/08/28 2008/08/28 2008/08/28 2008/08/28 2008/08/28 2008/08/28 2008/08/28 2008/08/28 2008/08/28 2008/08/28 2008/08/28 2008/08/28 2008/08/28 2008/08/28 2008/08/28 2008/08/28 2008/08/29 2008/08/29 2008/08/29 2008/08/29 2008/08/29 2008/08/29
Philips Medical System Siemens Ltd. Johnson & Johnson Medical (HK) Medtronic International Limited N/A Beckman Coulter Hong Kong Ltd Boston Scientific HK Limited Abbott Laboratories Ltd. Covidien Stryker China Ltd Stryker China Ltd Siemens Ltd. N/A Bio-Rad Pacific Ltd. N/A AMO Asia Limited N/A N/A N/A N/A Philips Medical System N/A Siemens Limited N/A Medtronic International Limited Baxter Healthcare Ltd N/A Philips Medical System GE Medical Systems Hong Kong Ltd. BrainLAB Ltd. (Hong Kong) N/A
2876 7525 2810 7533 2738 2818 2919 1300 N/A 2240 6150 2960 7136 2806 4021 2574 3251 2518 6988 2518 6988 2810 7533 N/A 2789 3300 N/A 2480 3330 N/A N/A N/A N/A 2876 7525 N/A 2810 7533 N/A 2919 1300 2807 8500 N/A 2876 7525 2783 1838 N/A N/A
Medical Device Control Office
52
Department of Health The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - July 2008
Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. Description of Product No. SN080701 Invacare Action³ manual wheelchair SN080702 SN080703 SN080704 SN080705 SN080706 SN080707 SN080708 SN080709 SN080710 SN080711 SN080712 SN080713 SN080714 SN080715 SN080716 SN080717 SN080718 SN080719 SN080720 SN080721 SN080722 SN080723 SN080724 SN080725 SN080726 Abbott Diagnostics ARCHITECT c8000 System Anspach Sterile Single-use Cuting Burrs Arrow International Cannon catheter , Cannon catheter II and Edge catheter TerumoTubing packs for extracorporeal circulation of blood BioMerieux Agars 43001, 43041, and 43401 Handicare B.V. Beatle / Puma power wheelchairs Biomet UK Lactosorb L Template Stryker Reflex Revision Screwdriver BioLytical Laboratories INSTI HIV-1 /HIV-2 antibody test Sunrise Medical Groove Power Wheelchairs Medtronic Sutureless Connector Intrathecal Catheters Remploy Access & Accent wheelchair Beckman Coulter Access Ultra sensitive Insulin Assay Kit (Part Number 33410) Stryker Solar HA Humeral Stem with Plasma Coating 7mm to 17mm AGFA HeartLabCardiovascular DICOMstore (Model # L9M8E) AGFA HeartLab Cardiovascular Results Management Product (Model No.: L58RZ and L9MWQ) AGFA IMPAX 6.2.1 Network Gateway Server, License Key (Catalog # ABC) Boston Scientific Lumenis/Slimline Fiber Strippers Kentec Medical Reusable Ohmeda Compatible Finger Clip Sensor (Model Number: E403-02, Product code: PS2225) Medline IL Latex-Free Breathing Bags,; Reservoir Bags Huntleigh Healthcare BabyCare crib trolleys Smiths Medical Graseby Omnifuse and Omnifuse PCA syringe Source of Information MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA FDA FDA FDA FDA FDA Boston Scientific Hong Kong Ltd FDA FDA MHRA MHRA Reference No. by Source MDA/2008/044 2008/006/002/601/380 2008/006/011/291/004 2008/006/018/061/010 2008/005/021/401/005 2008/006/018/601/425 2008/001/007/301/001 2008/005/021/061/017 2008/006/012/291/005 2008/006/011/401/013 2008/003/003/261/001 2008/006/025/061/013 2007/010/023/261/001 Z-1160-2008 Z-1236-2008 Z-1241-2008 Z-1242-2008 Z-1306-2008 N/A Z-1188-2008 Z-1162-2008 to Z-1164-2008 MDA/2008/048 MDA/2008/049 N/A 2008/001/010/401/007 2008/006/025/181/011 Alert Type by Source MDA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA Class II Class II Class II Class II Class II Firm Initiated Field Action Class II Class II MDA MDA Firm Initiated Field Action FSCA FSCA Date of Issue (YYYY/MM/DD) 2008/07/02 2008/07/02 2008/07/02 2008/07/02 2008/07/02 2008/07/02 2008/07/02 2008/07/02 2008/07/02 2008/07/02 2008/07/03 2008/07/03 2008/07/03 2008/07/03 2008/07/03 2008/07/03 2008/07/03 2008/07/03 2008/07/03 2008/07/03 2008/07/03 2008/07/03 2008/07/03 2008/07/07 2008/07/07 2008/07/07 Local Agent N/A Abbott Laboratories Ltd. N/A N/A TERUMO CHINA (H.K.) LTD. Biomerieux China Ltd (HK) N/A N/A Stryker China Ltd N/A N/A Medtronic International, Ltd. N/A Beckman Coulter Hong Kong Ltd Stryker China Ltd AGFA Hong Kong Limited AGFA Hong Kong Limited AGFA Hong Kong Limited Boston Scientific Hong Kong Ltd N/A N/A N/A Goodman Medical Supplies Ltd Alcon Hong Kong Ltd N/A Draeger Medical Hong Kong Ltd. Agent Contact Telephone No N/A 2806 4021 N/A N/A 2866 0811 N/A N/A N/A 2518 6915 N/A N/A 2919 1300 N/A 2240 6150 2518 6915 2555 9421 2555 9421 2555 9421 2960 7136 N/A N/A N/A 2332 4455 2161 0844 N/A 2877 3077
Alcon MONARCH II IOL Delivery System - Cartridge Model B ( Pat # Alcon Hong Kong Ltd 8065977758; Lot#: 174244, 174250) Park House Healthcare PHP 198, PHP396, PHP398 & PHP399 MHRA Pumps Draeger Medical Intensive Care ventilators MHRA
Medical Device Control Office
53
Department of Health The Government of HKSAR
SN080727 SN080728 SN080729 SN080730 SN080731 SN080732 SN080733 SN080734 SN080735 SN080736 SN080737 SN080738 SN080739 SN080740 SN080741 SN080742 SN080743 SN080744 SN080745 SN080746 SN080747 SN080748 SN080749 SN080750 SN080751 SN080752 SN080753 SN080754 SN080755 SN080756 SN080757
TherapostureTheracare Beds supplied with Mesh Linked Padded Rails Medtronic SynchroMed® II Implantable Infusion Pump Liko AB Universal SlingBar Invacare Harrier Heavy Duty (HD) battery powered wheelchair Quest 88 Kaye Posture Control Walkers Steris Quick Connect (Model QXCXXXX) Cardinal Health A) Sterile Line Pack, B) Sterile Primary Spinal Pack, C) Sterile Cardiovascular Universal Siemens Oncor Expression (Model 7360717, 8139839) Siemens AG Somatom Definition (Model 7741445) GE Healthcare Precision RX/I Remote Imaging System (Model 5117828) Trinity Biotech D-Dimer High Control Cordis Smart Control Nitinol Stent System (Model C10040SL) Siemens AG Magicview 300 (Model VA60A) Siemens Mevasim-S, Simview 3000, Simview NT Siemens Dimension Automated LDL Calibrator (Model DC131) Walter Lorenz Surgical 4MM Stella Osteotomes (Model 01-0575), 6MM Stella Osteotomes (Model 01-0576) Nonin Model PalmSAT handheld pluse Oximeter Philips Collimators 989601000612, 989601000614, 989601000615 Siemens Advia 120, 2120, Roche Myoglobin Control Set AGFA Drystar AXYS Elekta Precise Treatment Table Computerized Medical Systems Monaco Edwards LifeStent FlexStar Biliary Stent System AGFA Impax 4.5, 5.1, 5.2 ans 5.2x Picture Archiving System (PACs) Stryker Peek Electrosurgical Handle GE OEC Medical Systems Aspirators (Model 1006236-001) Siemens Coherence Oncologist (Model 7351898) Balder Battery powered wheelchairs Siemens Mevatron Primus, Mevatron MX-2, Oncor Expression, Oncor Impression IMRT Plus Lomax Mobility Kid Active Folding Frame with Swing Away Footrests
MHRA MHRA MHRA MHRA MHRA Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada FDA FDA Health Canada Health Canada Health Canada MHRA Health Canada MHRA
2007/009/027/401/001 2008/005/029/291/001 2008/006/024/071/002 MDA/2008/050 2007/011/015/401/003 38366 39224 39313 39782 40889 41341 41441 41521 41532 41796 42037 42163 42275 42277 42325 42393 42401 42691 Z-1246-2008 to Z-1296-2008 Z-1307-2008 34279 36242 42716 2008/004/003/301/001 42781 2007/012/006/061/004
FSCA FSCA FSCA MDA FSCA Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Class II Class II Type II Type II Type II FSCA Type II FSCA
2008/07/07 2008/07/07 2008/07/07 2008/07/08 2008/07/08 2008/07/10 2008/07/10 2008/07/10 2008/07/10 2008/07/10 2008/07/10 2008/07/10 2008/07/10 2008/07/10 2008/07/10 2008/07/10 2008/07/10 2008/07/10 2008/07/10 2008/07/10 2008/07/10 2008/07/10 2008/07/10 2008/07/10 2008/07/10 2008/07/11 2008/07/11 2008/07/11 2008/07/11 2008/07/11 2008/07/14
N/A Medtronic International, Ltd. N/A N/A N/A Swedish Trading Co., Ltd Cardinal Health Siemens Ltd. Siemens Ltd. GE Medical Systems Hong Kong Ltd. N/A Johnson & Johnson Medical Hong Kong Siemens Ltd. Siemens Ltd. Siemens Ltd. Swedish Trading Co., Ltd At-Home Healthcare Company Ltd Philips Medical Systems Regional Office (Asia Pacific) Siemens Ltd. Roche Diagnotics (Hong Kong) Ltd. AGFA Hong Kong Limited Elekta Ltd N/A N/A AGFA Hong Kong Limited Stryker China Ltd GE Medical Systems Hong Kong Ltd. Siemens Ltd. N/A Siemens Ltd. N/A
N/A 2919 1300 N/A N/A N/A N/A N/A 2810 7533 2810 7533 2783 1838 N/A 2738 2818 2810 7533 2810 7533 2810 7533 N/A N/A 2821 5480 2810 7533 2485 7510 2555 9421 N/A N/A N/A 2555 9421 2518 6915 2783 1838 2810 7533 N/A 2810 7533 N/A
Medical Device Control Office
54
Department of Health The Government of HKSAR
SN080758 SN080759 SN080760 SN080761 SN080762 SN080763 SN080764 SN080765 SN080766 SN080767 SN080768 SN080769 SN080770 SN080771 SN080772 SN080773 SN080774 SN080775 SN080776 SN080777 SN080778 SN080779 SN080780 SN080781 SN080782 SN080783 SN080784 SN080785 SN080786 SN080787 SN080788 SN080789 SN080790
Electric Mobility Scooters Q'Straint Wheelchair tie-downs Edwards Lifesciences Fogarty FortisTM Catheter Philips Medical Systems Allura Xper and Integris Systems Becton Dickinson BDTM Saline Syringers Gyrus ACMI Dual Lumen Catheter GE Healthcare vascular systems Sorin Biomedica Cardio Freedom Solo Biological Heart Valve Zimmer NexGen® Complete Knee Solution Boston Scientific Platinum PlusT Cononary Guidwire Dade Behring StratusR CS Acute Care? Troponin I TestPaks Abbott ARCHITECT Total -HCG calibrator ArthroCare Covator Arthro Wand Philips Medical Systems Biopsy Guide Starter Kits BD Vacutainer Blood Collection Tubes Containing Heparin Respironics PLV100 Ventilator (#RCA200802) Kimal safety fistula needle Handicare Puma and Beatle battery powered wheelchairs Nucletron SPOT Pro v3.0 Unomedical OP suction tubing Smiths Medical PortexTM Blue Line Ultra tracheostomy kits Philips Healthcare HeartStart OnSite automated external defibrillators (AEDs) Dade Behring ADVIA Chemistry Systems Abbott Molecular m2000sp Instrument Beckman Coulter GEN.S and LH SlideMakers Roche cobas b 221 Software version 7.0 Applied Medical 15mm SeparatorR access systems GE Healthcare Innova ® single plane cardiovascular Xray imaging systems Q'Straint Wheelchair QLK-100 Docking System Stryker Navigation Pin, Ortholock EX Pin, and Ortholock QLK-100 Docking System Bayer 5 second Contour blood glucose monitoring system DEAS Heated Wire Circuits Ventana Benchmark and Discovery Series Instruments
MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA BD CELKI Medical Company MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA
2007/008/002/301/003 2008/004/003/301/003 2008/006/030/061/018 2008/007/001/061/020 2008/006/030/061/002 2008/006/027/601/455 2008/007/001/061/014 2008/007/009/061/010 2008/007/002/061/012 2008/007/001/061/022 2008/007/002/061/014 2008/006/015/601/416 2008/004/016/401/009 2008/007/003/061/008 N/A N/A MDA/2008/051 MDA/2008/052 2008/007/003/061/009 MDA/2008/053 MDA/2008/054 2008/007/003/061/012 2008/007/002/061/013 2008/007/003/601/464 2008/007/002/601/459 2008/007/007/061/008 2008/007/008/061/006 2008/006/018/601/424 2008/004/009/401/001 2008/006/024/051/008 2008/007/003/601/463 2008/005/014/401/002 2008/007/011/061/017
FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA Firm Initiated Field Action Firm Initiated Field Action MDA MDA FSCA MDA MDA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA
2008/07/14 2008/07/14 2008/07/14 2008/07/14 2008/07/14 2008/07/14 2008/07/14 2008/07/14 2008/07/14 2008/07/14 2008/07/16 2008/07/16 2008/07/16 2008/07/17 2008/07/21 2008/07/21 2008/07/22 2008/07/22 2008/07/22 2008/07/24 2008/07/24 2008/07/24 2008/07/24 2008/07/24 2008/07/24 2008/07/24 2008/07/24 2008/07/24 2008/07/24 2008/07/24 2008/07/24 2008/07/24 2008/07/24
N/A N/A N/A PHAROS INTERNATIONAL LTD. BD Asia Ltd (Hong Kong) N/A GE Medical Systems Hong Kong Ltd. N/A Zimmer PTE Ltd. (Hong Kong branch) Boston Scientific HK Ltd Siemens Ltd. Abbott Laboratories Ltd. N/A Philips Medical Systems Regional Office (Asia Pacific) BD Asia Ltd (Hong Kong) CELKI Medical Company N/A N/A N/A N/A N/A Philips Medical Systems Regional Office (Asia Pacific) Siemens Ltd. Abbott Laboratories Ltd. Beckman Coulter Hong Kong Ltd Roche Diagnotics (Hong Kong) Ltd. N/A GE Medical Systems Hong Kong Ltd. N/A Stryker China Ltd Bayer Healthcare N/A N/A
N/A N/A N/A N/A 2722 5660 N/A 2783 1838 N/A 2992 0968 2810 7533 2806 4021 N/A 2821 5480 2722 5660 2268 9258 N/A N/A N/A N/A N/A 2821 5480 2810 7533 2806 4021 2240 6150 2485 7510 N/A 2783 1838 N/A 2518 6915 2814 4836 N/A N/A
Medical Device Control Office
55
Department of Health The Government of HKSAR
SN080791 SN080792 SN080793 SN080794 SN080795 SN080796 SN080797 SN080798 SN080799 SN080800 SN080801 SN080802 SN080803 SN080804 SN080805 SN080806 SN080807 SN080808 SN080809 SN080810 SN080811 SN080812 SN080813 SN080814 SN080815 SN080816 SN080817 SN080818 SN080819
Otto Bock HealthcareKimba Inline Twin Mobility Base Units Sunrise Medical Rumba Power Wheelchairs Orthodocs Cocoon Carina VT Homecare, intensive care and transport ventilators Siemens Healthcare Laboratory analysers Sunrise Medical Mermaid, Ranger & Dipper Bathing Products Agfa IMPAX Clients 6.x BD 60ml Luer-Lok Syringe (Recorder no. 309653) Abbott Sequoia Spinal System Surgical Kits Medtronic Intrathecal Catheter Pump Segment Revision Kit (Model no 8596SC) BHM Medical Infrared (IR) Hand Control System AMS In-Fast Ultra Kit with Polypropylene Suture (Ref 72403885) Smiths Medical FLO2 Emergency Non-rebreather High Flow O2 System and Oxy-PEEP High Flow O2 with PEEP Celsus Laboratories Heparin Lithium Lithium Lyophilized Sunrise Medical Manual and Powered Wheelchairs Abbott ARCHITECT AFP assay Hill-Rom Affinity® Four Birthing Bed Karomed COMM-METAL Supreme Profiling Bed Technical Service Consultants Urine collection bottle Aidservice Medi-Tec Classic hoist Troponin I Rapid Test and Myoglobin/CK-MB/Troponin I Combo Test Fresenius Injectomat 50ml syringe Philips Axis and Irix Gamma Cameras Beckman Coulter Acetaminophen Reagent Stryker Triathlon TS Fermoral Trial Beckman Coulter Cytomics FC 500 Flow Cytometry System with CXP Software version 2.1 and 2.2 Biomet Vanguard DCM CR Tibial Bearing Medline Eudur02 Oxygen Concentrator with Oxygen Monitor Philips A)Brilliance 64 Slice CT System-Main Unit, B) Brilliance CT Computed Tomography System,
MHRA MHRA MHRA MHRA MHRA MHRA MHRA BD FDA FDA FDA FDA FDA FDA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA FDA FDA FDA FDA Health Canada
2006/003/014/401/005 2007/009/020/291/012 2008/006/006/401/006 MDA/2008/055 MDA/2008/056 2007/012/004/061/013 2008/006/013/061/001 N/A Z-1479-2008 Z-1308-2008 Z-1233-2008 Z-1235-2008 Z-1379-2008 to Z-1380-2008 Z-1917-2008 2007/003/006/401/005 2008/007/011/601/482 2008/007/011/061/018 2008/003/031/401/003 MDA/2008/057 MDA/2008/058 2008/007/021/061/008 2008/007/015/061/014 2008/007/014/061/004 2008/007/024/601/509 Z-1572-2008 to Z-1587-2008 Z-2016-2008 to Z-2033-2008 Z-1375-2008 to Z-1376-2008 Z-1473-2008 to Z-1474-2008 42936
FSCA FSCA FSCA MDA MDA FSCA FSCA Firm Initiated Field Action Class II Class II Class II Class II Class II Class II FSCA FSCA FSCA FSCA MDA MDA FSCA FSCA FSCA FSCA Class II Class II Class II Class II Type II
2008/07/24 2008/07/24 2008/07/24 2008/07/25 2008/07/25 2008/07/25 2008/07/25 2008/07/28 2008/07/28 2008/07/28 2008/07/28 2008/07/28 2008/07/28 2008/07/28 2008/07/28 2008/07/28 2008/07/28 2008/07/28 2008/07/29 2008/07/31 2008/07/31 2008/07/31 2008/07/31 2008/07/31 2008/07/31 2008/07/31 2008/07/31 2008/07/31 2008/07/31
N/A N/A N/A N/A Siemens Ltd. N/A AGFA Hong Kong Limited BD Asia Ltd (Hong Kong) Abbott Laboratories Ltd. Medtronic International Ltd Arjo Far East Ltd N/A N/A N/A N/A Abbott Laboratories Ltd. N/A N/A N/A N/A N/A N/A Philips Medical Systems Regional Office (Asia Pacific) Beckman Coulter Hong Kong Ltd Stryker China Ltd Beckman Coulter Hong Kong Ltd N/A N/A Philips Medical Systems Regional Office (Asia Pacific)
N/A N/A N/A N/A 2810 7533 N/A 2555 9421 2722 5660 2806 4021 2919 1300 2508 9553 N/A N/A N/A N/A 2806 4021 N/A N/A N/A N/A N/A N/A 2821 5480 2240 6150 2518 6915 2240 6150 N/A N/A 2821 5480
Medical Device Control Office
56
Department of Health The Government of HKSAR
SN080820 SN080821 SN080822 SN080823 SN080824 SN080825 SN080826 SN080827 SN080828 SN080829 SN080830 SN080831 SN080832 SN080833 SN080834 SN080835
Philips A) Brilliance 40/64 Slice CT System, B) Brilliance CT Big Bore System-Main Unit, C) Brilliance CT System (16P), D) Brilliance 6/10/16 Slice CT System Biomet Microfixation 1.5X5MM HT X-DR SCREW (Model 91-1505, 95-1505) GE Datex Ohmeda A) Giraffe Warmer M1118179, B) Panda Warmer M1110875 Stryker Vertier Surgical Tables Gambro Bioline, Hermoline Stryker 3.5MM Super 90-S Serfas Suction Probe (Model 0279-351300) GE OEC Secondary Collimator Filter On OEC 9600 (Model 2274014) Gambro Dasco SPA Phoenix Hemodialisis Delivery System (Model 6022933700) Philips A) Prism 1000S, B) Prism 1000XP, C) Prism 2000S, D) Prism 2000XP Maquet Cardipulmonary AG Remote Control Unit (Model 939401) Zimmer Miller Bone Cement Injector Front Cartridge Kit (Model 005069-052-00) Stryker Howmedica Ostenoics Corporation Scorpio 7000 Tibial Impactor Extractor (Model 3770-000) Biomet 3I Navigator Surgical Guide Kit (SGKIT) Fisher Scientific Formalin Neutral Buffered 10% (Model SF-100-20, SF100-4) Wright Medical Technology Dynasty Trial Shell (Model 3300GG62, 3300GH64, 3300GH66, 3300GH68) Becton Dickson BBL MGIT Mycrobacteria Growth Tubes, Bactec MGIT 960 PZA Kit
Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada
42569 42390 42766 43004 42406 42939 42974 42906 32350 41063 43002 42982 42387 42764 42696 41508
Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II
2008/07/31 2008/07/31 2008/07/31 2008/07/31 2008/07/31 2008/07/31 2008/07/31 2008/07/31 2008/07/31 2008/07/31 2008/07/31 2008/07/31 2008/07/31 2008/07/31 2008/07/31 2008/07/31
Philips Medical Systems Regional Office (Asia Pacific) Biomet Microfixation GE Medical Systems Hong Kong Ltd. Stryker China Ltd Gambro Hong Kong Ltd Stryker China Ltd GE Medical Systems Hong Kong Ltd. Gambro Hong Kong Ltd Philips Medical Systems Regional Office (Asia Pacific) Maquet Hong Kong Ltd Zimmer PTE Ltd. (Hong Kong branch) Stryker China Ltd Ositek Inc Ltd N/A N/A BD Asia Ltd (Hong Kong)
2821 5480 N/A 2783 1838 2518 6915 2839 7010 2518 6915 2783 1838 2839 7010 2821 5480 2393 9511 2992 0968 2518 6915 8121 6601 N/A N/A 2722 5660
Medical Device Control Office
57
Department of Health The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts -June 2008
Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. Description of Product No. Baush and Lomb Zyoptix Treatment Calculator (Versions 1.1 and SN080601 1 2) SN080602 Boston Scientific FilterWire EZT Embolic Protection Systems SN080603 SN080604 SN080605 SN080606 SN080607 SN080608 SN080609 SN080610 SN080611 SN080612 SN080613 SN080614 SN080615 SN080616 SN080617 SN080618 SN080619 SN080620 SN080621 SN080622 SN080623 SN080624 SN080625 SN080626 SN080627 SN080628 SN080629 SN080630 SN080631 Hitachi Hi-Vision Ultrasound System Siemens ADVIA Centaur CP Thermogenesis Vapor Bypass Assembly (110v/220v) Varian TPS Eclipse Stryker Kinemax Plus Revision TS Tibial Insert Abbott Clinical Chemistry Iron/Magnesium Calibrator (Model 1E6903) AGA Medical Amplatzer PFO Occluder Arrow Balloon Temporary Pacing Catheter Kit BHM Ergiscake Scake abd Swivel Bar Bio-Rad Liquicheck Cardiac Markers Level 1, 2, 3, Plus Control and minipak Bio-Rad Varient B-Thalassemia Short Program Cardinal Health Sterile Mammoplasty Pack, Sterile Total Knee Pack and Othopedie-Fusion Posterieure Cook Hilal Embolization Coils Hill-Rom 100 Low Beds Imaging Sciences I-CAT 17-19, 3D Dental Imaging System (Model 1-10-1-0) and I-Cat 3D Imaging System- Main Unit (Model 91400000-0000) Johnson and Johnson Depuy Lupine BR Anchor With Orthocord Johnson and Johnson Ortho-Clinical Diagnostics Blood Gruping Reagent Anti-S Medtronic Lifepak Internal Defibillator Electrodes, Lifepak 9, 9p, 12 & 20 Int. Defibillator Handles Nova Biomedical Statstrip Glucose Hospital Meter Oxoid Haemophilus Selective Agar Philips Brilliance CT 16 Power Slice Philips Suresigns VS3 Vital Signs Monitor Pulmonetic Systems LTV 800, 950, 900 and 1000 Series Ventilators Randox Triglycerides Roche Elecsys Progesterone II Stryker SDC Ultra Tyco CT 9000 ADV Injector with Console Tyco Optivantage DH Power Injection System Walter Lorenz Surgical Epker Osteotome (BOTH Slightly Curved and Straight) Source of Information Bausch and Lomb Boston Scientific Hong Kong Ltd MHRA MHRA MHRA Affaps MHRA Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Reference No. by Source N/A N/A 2008/005/006/291/003 2008/005/013/041/007 2008/005/014/061/004 N/A 2008/005/009/121/006 42116 41996 41991 41995 41858 42066 42115 42174 41708 42021 42075 42071 40792 42078 42190 40156 42049 41278 41875 41845 40955 42024 42026 41577 Date of Issue (YYYY/MM/DD) Firm Initiated Field Action 2008/06/02 Alert Type by Source Firm Initiated Field Action FSCA FSCA FSCA N/A FSCA Type II Type II Type II Type II Type II Type II Type II Type II Type II Type I Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II 2008/06/02 2008/06/02 2008/06/02 2008/06/02 2008/06/03 2008/06/04 2008/06/05 2008/06/05 2008/06/05 2008/06/05 2008/06/05 2008/06/05 2008/06/05 2008/06/05 2008/06/05 2008/06/05 2008/06/05 2008/06/05 2008/06/05 2008/06/05 2008/06/05 2008/06/05 2008/06/05 2008/06/05 2008/06/05 2008/06/05 2008/06/05 2008/06/05 2008/06/05 2008/06/05 Local Agent Baush and Lomb Boston Scientific Hong Kong Ltd N/A Siemens Ltd. N/A N/A Stryker China Ltd Abbott Laboratories Ltd. AGA Medical Corporation (Asia Pacific) N/A Arjo Far East Ltd Bio-Rad Pacific Ltd. Bio-Rad Pacific Ltd. Cardinal Health Cook Asia (Hong Kong) Ltd. N/A N/A Johnson & Johnson Medical Hong Kong Johnson & Johnson Medical Hong Kong Medtronic International, Ltd. N/A N/A Philips Electronics Hong Kong Ltd. Philips Electronics Hong Kong Ltd. N/A N/A Roche Diagnostics (Hong Kong) Limited Stryker China Ltd COVIDIEN COVIDEN N/A Agent Contact Telephone No 2213 3371 2960 7136 N/A 2810 7533 N/A N/A 2518 6988 2806 4021 N/A N/A 2508 9553 2789 3300 2789 3300 N/A 2781 0232 N/A N/A 2738 2818 2738 2818 2919 1300 N/A N/A 2876 7525 2876 7525 N/A N/A 2485 7510 2518 6988 3157 7220 3157 7220 N/A
Medical Device Control Office
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Department of Health The Government of HKSAR
SN080632 SN080633 SN080634 SN080635 SN080636 SN080637 SN080638 SN080639 SN080640 SN080641 SN080642 SN080643 SN080644 SN080645 SN080646 SN080647 SN080648 SN080649 SN080650 SN080651 SN080652 SN080653 SN080654 SN080655 SN080656 SN080657 SN080658 SN080659 SN080660 SN080661 SN080662
Zimmer Dermacarriers Skin Graft Carriers and Dermacarriers II Skin Graft Carriers AquaJoy battery chargers (Serial no. 0638) IBG Immucor Galileo Echo Innogenetics INNO-LIA Syphilis Score (Product code 80542) Bausch & Lomb Zyoptix XP Microkeratome Motors (ZXP09183) Gambro Ultra filter U 8000 S (batch no. 8-3011-H-01) Philips Motiva Remote Patient Management System Zimmer NexGen Complete Knee Solution Articular Surface Insertion Instrument CMS XiO/Focal GE Healthcare OEC Uroview 2800, 9800 Plus, MiniView 6800, Flexiview 8800 Mobile C-Arm Siemens Mevatron and Oncor Control Console Versions V6.5.079, V7.2.079 and V9.1.50 Boston Scientific NAMIC MorseR Angiographic Manifold CalMed Pericardial Sump Cardinal Health U19 Socketed Integrated Circuit ("U19 IC"), Grey Inter-Unit Interface Connectors ("IUI") and U9 Socket Integrated Circuit ("U9 IC") GE Healthcare Proteus XR/a Radiographic System (Model Number 2259976) Siemens ADVIA Centaur Tnl-Ultra Assay, Troponin Immunoassay Accuray CyberKnife - Axum/Standard Treatment Couch BD Obturators for Venflon, Insyte and Adsyte Pro Galemed EMS Ventilator Single use non rebreathing patient circuit (Product code: W196-002; Lot 20070709) GE Healthcare 3.0T Signa HD Scanner (3.0T Propeller T2 Flair application) GE Healthcare Advantage Workstation GE Healthcare Centricity PASCS Software versions: 3.0.0X, 3.0.1X, 3.0.2.X AND 3.0.3X GE Healthcare DST-XL Carmera GE Healthcare Innova 2100IO, 3100/3100IQ and 4100/4100IQ Cardiovascular X-ray System GE Healthcare OEC 9900, 9800 and 8800 series GE Healthcare Pressure Sensitive Device (PSD) GE Healthcare S/5 iCentral versions L-NET03, L-NETC03, L-NET05, L-NETC05 Hansen Medical Artisan Control Catheter Johnson and Johnson Ethicon Endo-Surgery ENDOPATH ETS 35mm Philips X-Ray Systems with Monitor Ceiling Suspension Siemens ADVIA 1200, 1650, 1800 and 2400 Chemistry Systems
Health Canada MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA Boston Scientific Hong Kong Ltd FDA FDA FDA FDA Accuray Asia Ltd MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA
42114 2007/011/026/401/005 2008/005/015/061/008 2008/005/020/061/019 2008/005/008/181/011 2008/005/022/061/017 2008/005/013/061/017 2008/005/021/061/004 2008/003/022/601/200 2008/003/031/061/005 2008/005/001/291/016 N/A Z-1175-2008 to Z-1177-2008 Z-1710-2008 to Z-1712-2008 Z-0842-2008 Z-0580-2008 N/A 2008/005/022/061/020 2008/005/021/601/353 2008/005/030/061/027 2008/005/030/061/023 2008/006/003/291/010 2008/005/030/061/024 2008/005/030/061/034 2008/005/030/061/025 2008/003/025/061/015 2008/005/002/601/317 2008/005/028/061/019 2008/005/009/121/011 2008/006/003/291/004 2008/005/029/061/019
Type II FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA Firm Initiated Field Action Class II Class II Class II Class II Firm Initiated Field Action FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA
2008/06/05 2008/06/06 2008/06/06 2008/06/06 2008/06/10 2008/06/10 2008/06/10 2008/06/10 2008/06/11 2008/06/11 2008/06/11 2008/06/12 2008/06/12 2008/06/12 2008/06/12 2008/06/12 2008/06/16 2008/06/17 2008/06/17 2008/06/17 2008/06/17 2008/06/17 2008/06/17 2008/06/17 2008/06/17 2008/06/17 2008/06/17 2008/06/17 2008/06/17 2008/06/17 2008/06/17
Zimmer PTE Ltd. (Hong Kong branch) N/A N/A N/A Baush and Lomb Gambro China Ltd Philips Electronics Hong Kong Ltd. Zimmer PTE Ltd. (Hong Kong branch) N/A GE Healthcare Siemens Ltd. Boston Scientific Hong Kong Ltd N/A Cardinal Health GE Healthcare Siemens Ltd. Accuray Asia Ltd BD Asia Ltd (Hong Kong) N/A GE Healthcare GE Healthcare GE Healthcare GE Healthcare GE Healthcare GE Healthcare GE Healthcare GE Healthcare N/A Johnson & Johnson Medical Hong Kong Philips Electronics Hong Kong Ltd. Siemens Ltd.
2992 0968 N/A N/A N/A 2213 3371 2839 7010 2876 7525 2992 0968 N/A 2609 9233 2810 7533 2960 7136 N/A N/A 2609 9233 2810 7533 2247 8628 2575 8668 N/A 2609 9233 2609 9233 2609 9233 2609 9233 2609 9233 2609 9233 2609 9233 2609 9233 N/A 2738 2818 2876 7525 2810 7533
Medical Device Control Office
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Department of Health The Government of HKSAR
SN080663 SN080664 SN080665 SN080666 SN080667 SN080668 SN080669 SN080670 SN080671 SN080672 SN080673 SN080674 SN080675 SN080676 SN080677 SN080678 SN080679 SN080680 SN080681 SN080682 SN080683 SN080684 SN080685 SN080686 SN080687 SN080688 SN080689 SN080690 SN080691 SN080692 SN080693 SN080694
Specialised Orthotic Services Mojo, Maxi, Midi and Mini Stryker Secure II, Epic and Zoom Beds B Braun A/V Sets (Product Code 7210697) Boston Scientific NexStent Carotid Stent & MonorailR Delivery System Cardinal Health LTV ventilators Covidien Thoraseal II chest drainage unit GE Healthcare Precision 500D and Advantx Legacy R&F X-ray Systems GE Healthcare Engstrom Carestation Handicare Ibis XP power wheelchair Nottingham Rehab Supplies Columbia Toilet Support Baxa Exacta-Mix? 2400 Compounder BioMerieux VIDAS HBs AG Ultra Bio-Rad BIOPLEX 2200 SYPHILIS IgG Kit, EBV IgG KIT, CALIBRATORS, AND CONTROLS and MULTI-ANALYTE DETECTION SYSTEM Boston Scientific Platinum PlusT Coronary Guidewire Boston Scientific Safety PEG Kits Conmed DetachaTip Surgical Instruments GE LOGIQ3 Expert ultrasound scanner with software versions 4.0.5, 4.1.1 and 4.1.2 Huntleigh Healthcare Arjo Malibu Kimal Safety Fistula Needle Metrax Primedic Charger Basis PDG Bentley Manual Tilt Wheelchair Roche Diagnostics COBAS Integra 400 systems Siemens Medical Solutions Diagnostics Advia 120 & Advia 2120 St Jude Medical Livewire TC Ablation Catheter ThermoFisher Scientific PB0124A Columbia agar with chocolated horse blood Unomedical OP tubing (Lot No 182281) Varian Medical Systems VARIS Vision/System 6.5 Waldemar Link Megasystem-C Modular Components Coloplast Balloon Nephrostomy catheter with introducer (Ref. no. AJ6812 - AJ6822) Boston Scientific implantables devices, ICD and CRT-D Computerized Medical Systems XIO Radiation Treatment Planning System Philips Isite Ipacs (Model ISITE ENTERPRISE V.3.5, ISITE RADIOLOGY V.3.5, IVAULT V.3.5)
MHRA MHRA MHRA Boston Scientific Hong Kong Ltd MHRA MHRA MHRA MHRA MNRA MHRA MHRA MHRA FDA Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd MHRA FDA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA Coloplast (Hong Kong) Ltd Boston Scientific Hong Kong Ltd Health Canada Health Canada
2008/003/007/261/001 2008/003/006/061/012 2008/005/015/401/001 N/A 2008/006/009/291/011 MDA/2008/040 2008/005/030/061/029 2007/008/029/401/001 2007/010/009/401/003 2007/012/018/401/006 2008/006/012/601/405 2008/005/027/601/367 Z-1156-2008 to Z-1159-2008 N/A N/A 2008/006/009/291/009 Z-1155-2008 2007/009/007/301/001 2008/006/011/601/402 2008/006/011/291/005 2008/002/005/301/001 2008/006/005/291/003 2008/006/009/061/007 2008/006/013/291/011 2008/006/013/601/408 2008/001/022/401/007 2008/006/002/291/007 2008/004/010/061/011 N/A N/A 42336 42273
FSCA FSCA FSCA Firm Initiated Field Action FSCA MDA FSCA FSCA FSCA FSCA FSCA FSCA Class II Firm Initiated Field Action Firm Initiated Field Action FSCA Class II FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA Firm Initiated Field Action Firm Initiated Field Action Type II Type II
2008/06/17 2008/06/17 2008/06/19 2008/06/19 2008/06/19 2008/06/19 2008/06/19 2008/06/19 2008/06/19 2008/06/19 2008/06/23 2008/06/23 2008/06/23 2008/06/23 2008/06/23 2008/06/23 2008/06/23 2008/06/23 2008/06/23 2008/06/23 2008/06/23 2008/06/23 2008/06/23 2008/06/23 2008/06/23 2008/06/23 2008/06/23 2008/06/23 2008/06/25 2008/06/26 2008/06/27 2008/06/27
N/A Stryker China Ltd B Braun Medical Hong Kong Boston Scientific Hong Kong Ltd Cardinal Health COVIDIEN GE Healthcare GE Healthcare N/A N/A N/A Biomerieux China Ltd (HK) Bio-Rad Pacific Ltd. Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd N/A GE Healthcare Arjo Far East Ltd N/A N/A N/A Roche Diagnostics (Hong Kong) Ltd Siemens Ltd St Jude Medical N/A N/A N/A N/A Coloplast (Hong Kong) Ltd Boston Scientific Hong Kong Ltd N/A Philips Medical Systems Regional Office (Asia Pacific)
N/A 2518 6988 2277 6125 2960 7136 N/A 3157 7220 2609 9233 2609 9233 N/A N/A N/A 2356 7033 2789 3300 2960 7136 2960 7136 N/A 2609 9233 2508 9553 N/A N/A N/A 2485 7510 2810 7533 2996 7601 N/A N/A N/A N/A 3628 7428 2960 7136 N/A 2821 5480
Medical Device Control Office
60
Department of Health The Government of HKSAR
SN080695 SN080696 SN080697 SN080698 SN080699 SN080700 SN080701 SN080702 SN080703
Gambro cartridge blood set (Model 003410-510, 003410-710, 0141080XXXC) Maquet HL 30 Perfusion System Stryker Infravision Urethral Kit (Model 0220-180-516) Terumo Level Sensor II Pads, Gel included Medtronic Affinity NT Hollow Fiber Oxygenator Model CB511) GE Advantx LCLP+ Bi Plane Cardiac System, Advantx LCN+Angiographic System, Innova 2000 Cardiovascular System, Innova 2100 IQ Digital Imaging System, Innova 4100IQ Tables ITC Protime Microagulation System (Model PROTIMEPST) Thermogenesis Autoxpress Platform System (Model 8-5101-0) Immucor Corqc Test System, Panoscreen I/II/III (Model)
Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada
42069 41066 42415 41365 42402 40766 39337 41781 42166
Type II Type II Type II Type II Type II Type II Type II Type II Type II
2008/06/27 2008/06/27 2008/06/27 2008/06/27 2008/06/27 2008/06/27 2008/06/27 2008/06/27 2008/06/27
Gambro Hong Kong Ltd Maquet Hong Kong Ltd Stryker China Ltd TERUMO CHINA (H.K.) LTD. Medtronic-Mediland (Taiwan) Ltd GE Medical Systems Hong Kong Ltd. N/A N/A N/A
2839 7010 2393 9511 2518 6915 2866 0811 2919 1300 2783 1838 N/A N/A N/A
Medical Device Control Office
61
Department of Health The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts -May 2008
Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. Description of Product No. SN080501 SN080502 Abbott CELL-DYN Hemoglobin Reagent Syringe (Product Descriptiion: CDS HGB SRNGW/BU) Siemens ACUSON Sequoia Diagnostic Utrasound System (Material Number 8245875, 8246951,8267697) Source of Information FDA FDA FDA MHRA Baush and Lomb Accuray Asia Ltd MHRA MHRA FDA FDA FDA FDA Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Reference No. by Source Z-1165-2008 Z-0661-2008 Z-1055-2008 to Z-1093-2008 MDA/2008/031 N/A N/A 2007/011/020/061/002 2008/004/011/061/016 Z-1106-2008 Z-1104-2008 Z-0971-2008 to Z-0981-2008 Z-1102-2008 41756 41721 34725 41777 39316 41305 41543 41524 41407 Alert Type by Source Class II Class II Class II MDA Firm Initiated Field Action Firm Initiated Field Action FSCA FSCA Class II Class II Class II Class II Type II Type II Type II Type II Type II Type II Type II Type II Type II Date of Issue (YYYY/MM/DD) 2008/05/02 2008/05/02 2008/05/02 2008/05/02 2008/05/05 2008/05/05 2008/05/07 2008/05/07 2008/05/08 2008/05/08 2008/05/08 2008/05/08 2008/05/08 2008/05/08 2008/05/08 2008/05/08 2008/05/08 2008/05/08 2008/05/08 2008/05/08 2008/05/08 Local Agent Abbott Laboratories Ltd. Siemens Ltd. CELKI Medical Company N/A Baush and Lomb Accuray Asia Ltd N/A N/A Stryker China Ltd GE Healthcare Siemens Ltd. N/A Siemens Ltd. Siemens Ltd. Siemens Ltd. Medtronic International, Ltd. Medtronic International, Ltd. Varian Medical Systems Pacific Inc. N/A
Convatec, A Division of E.R. Squibb & Sons, L.L.C. (Hong Kong)
Agent Contact Telephone No 2806 4021 2810 7533 2268 9258 N/A 2213 3371 2247 8628 N/A N/A 2518 6988 2609 9233 2810 7533 N/A 2810 7533 2810 7533 2810 7533 2919 1300 2919 1300 N/A N/A 2519 9182 N/A
SN080503 Respironics Various Devices and Accessories SN080504 Truelife walking frames for adults and children SN080505 Bausch & Lomb XP MicroKeratome motors SN080506 Accuray CyberKnife Robotic Radiosurgery System MultiPlan Treatment Planning Sofetware (Catalog No 022986)
SN080507 Phonak Rubber Dome BTE hearing instruments SN080508 SN080509 Edwards Lifesciences Aquarius Regular Haemofiltration Machine with software version 4.01.11 Stryker Advanced Cement Mixer (ACM) Bowl and Base (REF 306554)
SN080510 GE Healthcare Centricity PACS RA1000 Workstation SN080511 Siemens Coherence AG Therapist SN080512 Seradyn QMS Vancomycin Reagents (Part Nimber 0373589) SN080513 Siemens Advia Centaur System and Advia Centaur XP System SN080514 Siemens Dimension TPSA Flex Reagent Cartridge SN080515 Siemens Mevatron and Oncor Linear Accelerators SN080516 Medtronic Hall Easy-Fit Prosthetic Heart VALVE (Aortic and Mitral) SN080517 Medtronic Bravo PH Capsule With Delivery System SN080518 Varian Medical Clinac High and Low Engery SN080519 Cardinal Health Custom Sterile Total Joint Pack SN080520 Convatec Gentle Touch 70mm Colo/Ileo PostOp Kit SN080521 National Biological Houva III
N/A
Medical Device Control Office
62
Department of Health The Government of HKSAR
SN080522 Biosense Webster Lasso Variable Deflectable CIR Map Catheter SN080523 Levitronix CentriMag Systems SN080524 Medtronic Heparin-Coated products SN080525 Biomerieux Vitek GPS Quinupristin/Dalfoprist Cards SN080526 Johnson and Johnson Ortho-Clinical Diagnostics Vitros 5,1 FS Chemistry System
Health Canada Health Canada Medtronic International Ltd Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada MHRA Convatec MHRA Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd MHRA MHRA MHRA MHRA MHRA FDA FDA FDA FDA FDA Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd
41774 41786 N/A 41574 41659 41705 41639 41552 41293 2008/004/009/301/001 N/A 2008/004/008/291/002 N/A N/A 2008/004/015/061/013 2007/012/022/601/001 2008/004/022/061/020 2008/004/023/061/013 2008/004/023/291/003 Z-1118-2008 Z-1543-2008 to Z-1545-2008 Z-1119-2008 Z-1141-2008 Z-1594-2008 to Z-1602-2008 N/A N/A
Type II Type II Firm Initiated Field Action Type II Type II Type I Type I Type II Type II FSCA Firm Initiated Field Action FSCA Firm Initiated Field Action Firm Initiated Field Action FSCA FSCA FSCA FSCA FSCA Class II Class II Class II Class II Class II Firm Initiated Field Action Firm Initiated Field Action
2008/05/08 2008/05/08 2008/05/08 2008/05/08 2008/05/08 2008/05/08 2008/05/08 2008/05/08 2008/05/08 2008/05/08 2008/05/09 2008/05/09 2008/05/14 2008/05/14 2008/05/14 2008/05/14 2008/05/14 2008/05/14 2008/05/14 2008/05/15 2008/05/15 2008/05/15 2008/05/15 2008/05/15 2008/05/16 2008/05/16
N/A N/A Medtronic International, Ltd. Biomerieux (Hong Kong) Johnson & Johnson Medical Hong Kong N/A N/A Ositek Inc Ltd Bio-Rad Pacific Ltd. N/A Convatec, A Division of E.R. Squibb & Sons, L.L.C. (Hong Kong) Zimmer PTE Ltd. (Hong Kong branch) Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd Goodwin Health Care Holdings Ltd Ultra Care Company Ltd N/A Gambro China Ltd N/A N/A N/A Siemens Ltd. Philips Electronics Hong Kong Ltd. COVIDIEN Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd
N/A N/A 2919 1300 2356 7033 2738 6000 N/A N/A 8121 6601 2789 3300 N/A 2519 9182 2992 0968 2960 7128 2960 7128 2408 8838 N/A N/A 2839 9710 N/A N/A N/A 2810 7533 2332 4455 3157 7244 2960 7128 2960 7128
SN080527 BHM Medical Medi-Lifter II Plus Patient Lift and Summit SN080528 A.L.N. Vena Cave Filter / Introduction Kit SN080529 Biomet 3i Certain Microminiplant Healing abutment SN080530 Bio-Rad Liquicheck Sedimentation Rate Control SN080531 Aidapt Isis shower board (Code No. R232) SN080532 Covatec Active Life Little One (20917) Zimmer Hemovac, HAS, Sergivac, Infection Control and MiniSN080533 Hemovac Systems SN080534 Boston Scientific iReview SoftwareVer1.0 SN080535 Boston Scientific OMG Connector-A Smiths Medical BCI Mini-Torr Plus NIBP Monitor with SpO2 & BuiltSN080536 in Printer, 6004 SN080537 P3 Medical Robertshaw Endobronchial tubes (PVC, Disposable) SN080538 Fisher & Paykel Healthcare Patient Warmers SN080539 Gambro Spectra Optia Apheresis System SN080540 Thoratec HeartMate II LVAS Fisher Healthcare Sure-Vue Serum/Urine hCD-STAT (Catalog no. SN080541 FHC-A202, Product Codes: FHC-A202-KFI3O and FHC-A202KFI5O) SN080542 Medefil Heparin I.V. Flush Syringe SN080543 Siemens ADVIA Centaur HAV IgM SN080544 Philips Healthcare iSite PACS image management system SN080545 Tyco Healthcare Monoject Prefill Boston Scientific Cutting Balloon Ultra Microsurgical Dilatation SN080546 Device SN080547 Boston Scientific LeVeen SuperSlimT Needle Electrodes
Medical Device Control Office
63
Department of Health The Government of HKSAR
SN080548
Baxter HomeChoice Automated Peritoneal Dialysis System (Software v.10.210)
Baxter Healthcare Ltd MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA FDA FDA FDA FDA
N/A 2008/004/024/061/011 2008/004/021/061/008 2008/003/028/401/001 2007/011/014/401/001 2008/001/017/301/001 2008/004/010/060/011 2008/004/030/061/013 2007/012/033/401/004 2008/003/006/061/008 2008/004/016/061/023 Z-0982-2008 to Z-0986-2008 Z-0987-2008 Z-1138-2008 Z-1105-2008 Z-1103-2008 2008/004/024/061/014 2008/004/003/061/010
Firm Initiated Field Action FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA Class II Class II Class II Class II Class II FSCA FSCA
2008/05/16 2008/05/19 2008/05/19 2008/05/19 2008/05/19 2008/05/19 2008/05/21 2008/05/21 2008/05/21 2008/05/21 2008/05/21 2008/05/22 2008/05/22 2008/05/22 2008/05/22 2008/05/22 2008/05/22 2008/05/22
Baxter Healthcare Ltd Boston Scientific Hong Kong Ltd Johnson & Johnson Medical Hong Kong CELKI Medical Company Firstar Healthcare Co., Ltd N/A N/A N/A N/A Goodman Medical Supplies Ltd N/A VIASYS Healthcare (Hong Kong) Ltd N/A Siemens Ltd. Stryker China Ltd Abbott Laboratories Ltd. Medtronic International, Ltd. Stryker China Ltd Dade Behring HK Ltd., A Siemens Company B Braun Medical Hong Kong N/A N/A N/A Dade Behring HK Ltd., A Siemens Company Dade Behring HK Ltd., A Siemens Company Dade Behring HK Ltd., A Siemens Company
2807 8500 2960 7128 2738 6000 2268 9258 N/A N/A N/A N/A N/A 2332 4455 N/A 6305 5575 N/A 2810 7533 2518 6988 2806 4021 2919 1300 2518 6988
SN080549 Boston Scientific iLab UltraSound Imaging System SN080550 Johnson and Johnson Codman ARCHIMEDES Drug Pumps SN080551 Respironics Humidifier Chambers SN080552 Firstar Plastic Vaginal Speculum SN080553 Dragonmobility Power-chairs SN080554 Waldemar Link Megasystem-C Modular Components Biotrin Nephkit Alpha GST EIA (Product Code: BIO66NEPHA, Lot SN080555 no 58KT036) SN080556 Chiltern Invadex Shower Trolleys and Shower/Changing Stretchers Smiths Medical Graseby Omnifuse and Omnifuse PCA Syringe SN080557 Pumps SN080558 Welch Allyn AED 10 SN080559 VIASYS AVEA Ventilator SN080560 Cardinal Health AirLife Infant Ncpap System Driver Siemens Syngo US Workplace Picture Archiving and SN080561 Communication System, software version 2.0, 94043 SN080562 Stryker Triathlon Baseplate Impactor Extractor (Catalog no. 6541-4805)
Abbott White Blood Cell (WBC) Reagent-Part A used with the SN080563 CELL-DYN 4000 and CELL-DYN Sapphire Systems , Red cell lysing reagent (List No. 01H77-01) SN080564 Medtronic LIFEPAK 12 and LIFEPAK 20/20e Defibrillator/Monitor Stryker Pegless Universal Scorpio Notch Guide (Catalog no 8000SN080565 3303) and Universal Scorpio Notch Preparation Guide (Catalog no 7650-3363) SN080566 Dade Behring Enzygnost Toxoplasmosis/IgG (OUNA27) in combination with Sample Buffer POD lot 426707
FDA MHRA MHRA
MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA
2008/004/029/061/002 2008/004/023/061/009 2008/004/025/061/001 2008/004/001/061/002 MDA/2008/033 2008/004/030/601/310 2008/004/029/061/003 2008/004/017/601/273
FSCA FSCA FSCA FSCA MDA FSCA FSCA FSCA
2008/05/22 2008/05/22 2008/05/22 2008/05/22 2008/05/22 2008/05/23 2008/05/23 2008/05/23
2810 7533 2277 6611 N/A N/A N/A 2810 7533 2810 7533 2810 7533
SN080567 B Braun Dialog+ Machines with DF Option SN080568 Sysmex CS-Series - Coagulation Analyser (all versions) SN080569 Biotrin Urinary Collagen IV EIA (Catalog Code BIO83) SN080570 Masimo Rainbow Rad-57 Pluse CO-Oximeter SN080571 Dade Behring Stratus CS Cardiac Troponin I Calpak (CCTNI-CR) Dade Behring N Latex CDT Kit (OPCS03) and N Latex CDT (kit) SN080572 (OPCS05) SN080573 Dade Behring Dimension Clinical Chemistry System
Medical Device Control Office
64
Department of Health The Government of HKSAR
SN080574
Beckman Coulter Access and Access 2 Immunoassay Systems, SYNCHRON LXi 725 System and UniCel DxC 600i System
MHRA Health Canada Health Canada Health Canada Health Canada Johnson & Johnson Medical Hong Kong Boston Scientific Hong Kong Ltd MHRA MHRA FDA MHRA MHRA MHRA MHRA
2008/004/028/601/297 41792 41867 41842 41844 N/A N/A 2008/005/009/121/004 2007/010/018/061/002 Z-1110-2008 to Z-1117-2008 2007/009/012/301/002 2008/004/008/061/008 2008/005/013/061/013 MDA/2008/035
FSCA Type II Type II Type II Type II Firm Initiated Field Action Firm Initiated Field Action FSCA FSCA Class II FSCA FSCA FSCA MDA
2008/05/23 2008/05/23 2008/05/23 2008/05/23 2008/05/23 2008/05/23 2008/05/26 2008/05/26 2008/05/26 2008/05/29 2008/05/29 2008/05/29 2008/05/29 2008/05/29
Beckman Coulter Siemens Ltd. N/A Cardinal Health Draeger Medical Hong Kong Ltd. Johnson & Johnson Medical Hong Kong Boston Scientific Hong Kong Ltd N/A N/A N/A N/A N/A Gambro China Ltd N/A
2240 6260 2810 7533 N/A N/A 2877 3077 2738 6000 2960 7136 N/A N/A N/A N/A N/A 2839 7010 N/A
SN080575 Siemens ACUSON Antares, Ultrasound System SN080576 Biosite Triage MeterPro SN080577 Cardinal Health Custom Sterile Hip Pack SN080578 Draeger Medical Oxylog 3000 SN080579 Johnson and Johnson STERRAD Sterilization Systems Oil Mist SN080580 Boston Scientific RotaWire Guidewire SN080581 ThermoFisher Scientific LAB VISION Pretreatment Module SN080582 Invacare Harrier Heavy Duty (HD) Powered Wheelchairs SN080583 Pointe Scientific Liquid ALT (SGPT) reagent set SN080584 Park House Healthcare VERSAtec Back SN080585 BPR Medical FireSafe Cannula Valves (Firebreak) SN080586 Gambro Hospal Blood Set SN080587 Invacare Storm and Storm True Track (TT) wheelchairs
Medical Device Control Office
65
Department of Health The Government of HKSAR
cal Device Safety Alerts -April 2008
and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. Description of Product No. SN080401 SN080402 Smith & Nephew Medullary Exchange Tube (Product Code 415113, Lot 07AM1186) Varian CT/MR Ring and Tandem Combination Applicator Set (AL13017000) Source of Information MHRA MHRA MHRA MHRA FDA FDA FDA AMO Asia Limited MHRA MHRA MHRA FDA FDA FDA MHRA MHRA MHRA MHRA MHRA MHRA Reference No. by Source 2007/004/019/601/816 2008/003/017/061/004 2008/003/017/061/015 2008/003/013/061/024 Z-1050-2008 Z-1310-2008 to Z-1313-2008 Z-1353-2008 to Z-1360-2008 N/A 2008/003/017/291/001 2008/003/019/061/007 MDA/2008/023 Z-1107-2008 Z-0617-2008 Z-1394-2008 to Z-1407-2008 2008/003/013/291/008 2008/003/013/291/014 2008/001/003/061/013 2008/003/012/061/002 2008/002/029/601/139 2008/003/025/061/013 Alert Type by Source FSCA FSCA FSCA FSCA Class II Class II Class II Firm Initiated Field Action FSCA FSCA MDA Class II Class II Class II FSCA FSCA FSCA FSCA FSCA FSCA Date of Issue (YYYY/MM/DD) 2008/04/03 2008/04/03 2008/04/03 2008/04/03 2008/04/03 2008/04/03 2008/04/03 2008/04/07 2008/04/08 2008/04/08 2008/04/09 2008/04/10 2008/04/10 2008/04/10 2008/04/10 2008/04/11 2008/04/11 2008/04/11 2008/04/14 2008/04/14 Local Agent Smith & Nephew Healthcare Ltd. Varian Medical Systems Pacific Inc. N/A N/A Medtronic International, Ltd. Terumo China (H.K.) Ltd. N/A AMO Asia Limited N/A N/A Hospira Ltd Stryker China Ltd N/A Siemens Ltd. N/A Stryker China Ltd N/A N/A N/A Abbott Laboratories Ltd. Agent Contact Telephone No 2648 7700 2724 2836 N/A N/A 2919 1300 2866 0811 N/A 2480 3330 N/A N/A 2285 8382 2518 6988 N/A 2810 7533 N/A 2518 6988 N/A N/A N/A 2806 4021
SN080403 Edwards Lifesciences VAMP Jr SN080404 BrainLAB BrainScan SN080405 LIFEPAK 20 Defibrillator/monitor SN080406 Terumo Cardiovascular Procedure Kit (P/N 70932-01, 64789-01, 70295-02, 70579-04)
SN080407 Pointe Scientific Liquid Alkaline Phosphatase Reagent Set SN080408 SN080409 SN080410 AMO WHITESTAR SIGNATURE Phacoemulsification System (NGP680300) ConMed Linvatec Hall Surgical Blades, Sterile, Single-use, packaged in Bilsters RITA Starburst XLie Radiofrequency Ablation Probe and Talon Radiofrequency Ablation Probe
SN080411 Hospira Butterfly winged needle infusion set SN080412 Skryker ACL Workstation slider (Model Number: 234-010-503) SN080413 Hill-Rom Affinity 4 Birthing Bed (Model P3700B) SN080414 Siemens Mevatron, Oncor, Primus Linear Accelerators SN080415 Leica Bond maX systems with cversion 03.05.08 Software instaled SN080416 Stryker Scorpio Knee Femoral Component (Catalog No. 70-5211R, 71-5211R, Lot Code: KNAMED, V8WMED)
SN080417 Medivance Instruments Velopex Extra X SN080418 Thermogenesis Disposable Processing Set for the AXP System 85101
SN080419 Elekta Stereotactic Body Frame CT and MRI indicators SN080420 Abbott OPTIUM-H Blood Glucose Test Strips (Lot no. 53929/ Part No. 80111-01)
Medical Device Control Office
66
Department of Health The Government of HKSAR
SN080421
Arcomedical 3101-TJ (FSB123) Blood Set with Lower Y site (Batches C8446)
MHRA Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd FDA FDA FDA FDA FDA FDA MHRA MHRA MHRA MHRA MHRA Health Canada Health Canada Health Canada Health Canada
2008/003/013/601/181 N/A N/A N/A N/A N/A N/A N/A N/A Z-1448-2008 to Z-1458-2008 Z-0689-2008 Z-0586-2008 to Z-0587-2008 Z-0712-2008 Z-0916-2008 Z-0843-2008 2008/003/031/291/008 2007/012/021/401/014 2008/002/028/601/134 MDA/2008/027 MDA/2008/026 41375 41371 41433 41374
FSCA Firm Initiated Field Action Firm Initiated Field Action Firm Initiated Field Action Firm Initiated Field Action Firm Initiated Field Action Firm Initiated Field Action Firm Initiated Field Action Firm Initiated Field Action Class II Class II Class II Class II Class II Class II FSCA FSCA FSCA MDA MDA Type II Type II Type II Type II
2008/04/14 2008/04/15 2008/04/15 2008/04/15 2008/04/15 2008/04/15 2008/04/16 2008/04/16 2008/04/16 2008/04/17 2008/04/17 2008/04/17 2008/04/17 2008/04/17 2008/04/17 2008/04/17 2008/04/18 2008/04/18 2008/04/18 2008/04/18 2008/04/21 2008/04/22 2008/04/22 2008/04/22
N/A Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd Zimmer PTE Ltd. (Hong Kong branch) Medtronic International, Ltd. N/A N/A L&S Dental Supplies Limited N/A Abbott Laboratories Ltd. N/A Siemens Ltd. N/A N/A N/A Goodwin Health Care Holdings Ltd Specialists' Dental Supplies Limited Specialists' Dental Supplies Limited
N/A 2960 7128 2960 7128 2960 7128 2960 7128 2960 7128 2960 7128 2960 7128 2960 7128 2992 0968 2919 1300 N/A N/A 2815 8115 N/A 2806 4021 N/A 2810 7533 N/A N/A N/A 2408 8838 9656 7000 9656 7000
SN080422 Boston Scientific RX Plastic Biliary Stents SN080423 Boston Scientific Precision Implantable Pluse Generator (UPN M365SC11100)
SN080424 Boston Scientific Mach 1 Guide Catheter SN080425 Boston Scientific Single-Use Rotatable Snares SN080426 Boston Scientific SteeroCath-Dx and SteeroCath-T Catheters Boston Scientific Epic Over-The-Wire Self-Expanding Nitinol Stent SN080427 with Delivery System Stent System SN080428 Boston Scientific Smash Balloon Dilation Catheter SN080429 Boston Scientific Various Products SN080430 Zimmer Hemovac Wound Drainage Device Infection Control Kits SN080431 Medtronic AneuRx AAAdvantage Endovascular Stent Graft with the Xcelerant Delivery System
Myelotec Steerable Video Guided Catheter (Product Code 2000 SN080432 and 2010) SN080433 CES Ultra, Cranial Electrotherapy Stimulator Ormco Grengloo (Unidose Tips), Bracket adhesive and tooth SN080434 conditioner (Part Number 740-0322) SN080435 Nonin Model 2500 PalmSAT handheld pluse Oximeter SN080436 Abbott Vascular Xact Rapid Exchange Carotid Stent System SN080437 SN080438 PROACT Silicone Disposable Armoured LMA SAD-LA6320, SADLA6325, SAD-LA3300, SAD-LA6340, SAD-LA6350 Siemens Medical IMMULITE 2000 CEA kit L2KCE2,6 lot 232 and IMMULITE 2500 CEA kit L5KCE2,6 lot 111
SN080439 Huntleigh Healthcare Well-Shin WS-023 power lead adapters SN080440 Huntleigh Healthcare Birthright birthing bed mattresses SN080441 BHM Medical Maxi Sky 600, V4 and V4i Ceiling Lifts SN080442 Smiths Medical BCI 3180 Pulse Oximeter (Model 3180) SN080443 Biohorizons Implant System Ratchet Extender (Model # 300-205) SN080444 Biohorizons Single-Stage Implant System 122-800 Kit (Model 122800)
Medical Device Control Office
67
Department of Health The Government of HKSAR
SN080445 Elekta PrecisePlan (Model # MRT 7131, MRT 7161) SN080446 Elekta iViewGT Electronical Portal Imaging (Model XRT 1261) Somagen IgM HRP ELISA Kit (Model LAPL-K-HRP-001GM, LAPLK-HRP-001M) Tornier Aequalis Shoulder (Kelled Glenoid and Cemented Glenoid) SN080448 and Latitude Elbow Prosthesis Cap, Radial Head and Ulnar Compon SN080449 Meridian Bioscience Immunocard Toxins A & B SN080447 SN080450 Trinity Biotech MDA Auto Dimer (Product Code T3103) SN080451 ITC AVOXimeter 1000 / AVOXimeter 1000E SN080452 MEDNET TOPS OUS Fusion System Medfor S400 and S227 Femoral Head Storage Pot, Labelled, SN080453 double wrapped SN080454 Merlin Medical Disposable pen torch (Model no. W2137) SN080455 GE Healthcare Drytec Tc-99m Generator (all sizes) SN080456 Cook Peel-Away Introducer set and Cook TPN Lumen Catheter set SN080457 BioRad BioPlex 2200 Instrument
Health Canada Health Canada Health Canada Health Canada Health Canada MHRA MHRA MHRA MHRA MHRA GE Medical Systems Hong Kong Ltd. FDA FDA
41295 41295 41158 41183 41330 2008/004/003/061/016 2008/002/021/061/018 2008/001/025/291/005 2008/002/029/601/140 MDA/2008/028 N/A Z-0892-2008 to Z-0904-2008 Z-0575-2008
Type II Type II Type II Type II Type II FSCA FSCA FSCA FSCA MDA Firm Initiated Field Action Class II Class II
2008/04/22 2008/04/22 2008/04/22 2008/04/22 2008/04/22 2008/04/23 2008/04/23 2008/04/23 2008/04/23 2008/04/23 2008/04/24 2008/04/24 2008/04/24
N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A GE Medical Systems Hong Kong Ltd. Cook Asia (Hong Kong) Ltd. Bio-Rad Pacific Ltd.
N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A 2783 1838 2781 0232 2789 3300
Medical Device Control Office
68
Department of Health The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts -March 2008
Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. Description of Product No. SN080301 SN080302 SN080303 SN080304 SN080305 SN080306 SN080307 SN080308 SN080309 SN080310 SN080311 SN080312 SN080313 SN080314 SN080315 SN080316 SN080317 SN080318 SN080319 SN080320 SN080321 Focus Diagnostics HerpeSelect 1 and 2 Immunoblot IgG Kit (CATALOG# IB0900G) Zoll Medical E Series Debribillator with 12 Lead ECG Stryker Howmedica Modular Replacement System, Distal Fem Walter Lorenz Surgical Pectus Table Top Bender (Trading as: Biomet Microfixation) Balt Extrusion Goldbal Detachable Balloons Roche Accutrend GC Stryker Howmedica Trident acetabular shell and Trident hemispherical shell Elekta Precise Plan Elekta Precise Treatment Table Elekta Leksell GammaPlan 8.0 Abbott Cell Dyn Sapphire Analyzer (model # 08H00-01) B Braun Aesculap FT420T-FT430T Caspar Aneurysm Clips APP Conmed Endoscopic Ligating Clip Applier (ELC) Technidata TD-Synergy V03.11.A BD Luer Slip Syringe Products (REF 301294, 301295, 30020) Terumo Weighed Flexible Sucker (Ref Code 804113) Trinity Biotech Bartels Viral Respiratory Screening and Identification Kit (Prodcut Code B1029-86) WMS Disposable Pen Torch W2137 (Batch Q01403, Q01408, Q01371) Baush and Lomb ReNu Comfort Drops (Lot No 225747 and 225757) Arjo Ambulift Hoist Advanced Bionics Precision Implantable Pluse Generator Kit (Model No. SC-1110) Source of Information Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada MHRA MHRA MHRA MHRA MHRA MHRA FDA Reference No. by Source 40290 40588 39226 39755 39555 39757 40619 40747 40457 40497 40557 40744 39961 40014 2008/002/001/181/009 2008/002/020/061/003 2008/002/021/291/008 2007/011/006/401/010 2008/002/011/061/014 MDA/2008/010 Z-0960-2008 to Z-0961-2008 Alert Type by Source Type II Type II Type I Type II Type II Type II Type II Type II Type II Type II Type II Type I Type II Type II FSCA FSCA FSCA FSCA FSCA MDA Class II Date of Issue (YYYY/MM/DD) 2008/03/03 2008/03/03 2008/03/03 2008/03/03 2008/03/03 2008/03/03 2008/03/03 2008/03/03 2008/03/03 2008/03/03 2008/03/03 2008/03/03 2008/03/03 2008/03/03 2008/03/05 2008/03/05 2008/03/05 2008/03/05 2008/03/05 2008/03/05 2008/03/06 Local Agent N/A N/A Stryker China Ltd N/A N/A Roche Diagnostics (Hong Kong) Limited Stryker China Ltd N/A N/A N/A Abbott Laboratories Ltd. B. Braun Medical (HK) Ltd N/A N/A BD Terumo China (H.K.) Ltd. N/A N/A Baush and Lomb N/A N/A Agent Contact Telephone No N/A N/A 2518 6988 N/A N/A 2485 7510 2518 6988 N/A N/A N/A 2806 4021 2277 6611 N/A N/A 2518 6988 2866 0811 N/A N/A 2213 3371 N/A N/A
Medical Device Control Office
69
Department of Health The Government of HKSAR
SN080322 SN080323 SN080324 SN080325 SN080326 SN080327 SN080328 SN080329 SN080330 SN080331 SN080332 SN080333 SN080334 SN080335 SN080336 SN080337 SN080338 SN080339 SN080340 SN080341 SN080342 SN080343 SN080344 SN080345 SN080346
American Medical Systems, Inc., GreenLight HPS Fiber Optic (ADDStat) (Part Number: 0010-2090B) TENET Medical Engineering Wrist Stabilization Kit Orthofix TrueLok External Ring Fixation System, Telescopic Linear Distractor (Catalog No. 50-10185) Philips Medical Allura XPER FD10 and FD10/10 with AD7 VNS Therapy Demipulse Generator (103) and Demipulse Duo Generator (104) Smiths Medical Logical, NovaTrans, and Transtar Invasive Pressure Monitoring Kits with Trigger Flush Device Biomet Vanguard Width Checker (Item Number # 32-487062) Zimmer Pulsavac Plus Wound Debridement System, Pulsavac Plus AC Component Kit, Pulsavac Fan Spray Kit and Hip Kit Stryker Disposable StrykeProbe 32 cm L-Tip and Spatula Tip Siemens ACUSON Aspen Diagnostic Ultrasound System (Model Number 8247887) Zimmer Allofit Shell Size 50 (Model 4244, Lot 2406181) Zimmer Hemovac Infection Control Kits Siemens Syngo Dynamica (Model 100 90 679; Serial # 92241, 93477, 95243, 95248) Siemens Leonardo Workstation (Model 7129534, Serial # 10413, 10434, 10599) Abbott Clinical Chemistry Phenytoin (Model IE07-20) Siemens Dade Behring Complement Reagents (Model OWZD11; Lot# 542849) Boston Scientific Advanced Bionics Clinician's Programmer Navigation V1.02 (Model P/N 9055528-001, SC-7150) Draeger Medical Fabius GS (Model# 8604700) Beckman Coulter IMMAGE C-Reactive Protein CRP Reagent (Model # 447280) VIASYS Microjack Patient Interface (Model # GP 320000-00) Cardinal Health Sterile Bowel Resection-Lithotomy Pack and Major Surgery Packs Johnson & Johnson, Ortho-Clinical Blood Grouping Reagent AntiLe Bioclone (Model# 715280) Coopersurgical Mystic II Pump with M-Style Mushrooncup (Model no 10057) Computerized Medical Systems Focal Workstation Allez Spine Size 8 Pedicle Screws (Catalo # LG-PR0835, LGPR0840, LG-PR0845, LG-PR0850, LG-PR0855, LG-PR0880)
FDA FDA FDA MHRA MHRA MHRA MHRA FDA FDA FDA Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada FDA
Z-0131-2008 Z-0577-2008 to Z-0579-2008 Z-0674-2008 2008/002/021/291/001 2008/002/021/061/003 2008/002/025/291/022 2008/002/019/061/010 Z-0856-2008 to Z-0865-2008 Z-0573-2008 to Z-0574-2008 Z-0719-2008 39593 40972 40885 40580 41000 39678 40881 40720 40898 40966 40924 38920 40725 40151 Z-0186-2008 to Z-0191-2008
Class II Class II Class II FSCA FSCA FSCA FSCA Class II Class II Class II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Class II
2008/03/06 2008/03/06 2008/03/06 2008/03/12 2008/03/12 2008/03/12 2008/03/12 2008/03/19 2008/03/19 2008/03/19 2008/03/19 2008/03/19 2008/03/19 2008/03/19 2008/03/19 2008/03/19 2008/03/19 2008/03/19 2008/03/19 2008/03/19 2008/03/19 2008/03/19 2008/03/19 2008/03/19 2008/03/25
N/A N/A N/A Philips Electronics Hong Kong Ltd. N/A N/A N/A Zimmer PTE Ltd. (Hong Kong branch) Stryker China Ltd Siemens Ltd. Zimmer PTE Ltd. (Hong Kong branch) Zimmer PTE Ltd. (Hong Kong branch) Siemens Ltd. Siemens Ltd. Abbott Laboratories Ltd. Siemens Ltd. Boston Scientific Hong Kong Ltd Draeger Medical Hong Kong Ltd. Beckman Coulter Hong Kong Ltd. VIASYS Healthcare (Hong Kong) Ltd N/A Johnson & Johnson Medical Hong Kong N/A N/A N/A
N/A N/A N/A 2876 7525 N/A N/A N/A 2992 0968 2518 6988 2810 7533 2992 0968 2992 0968 2810 7533 2810 7533 2806 4021 2810 7533 2960 7128 2877 3077 2240 6260 6305 5575 N/A 2738 2818 N/A N/A N/A
Medical Device Control Office
70
Department of Health The Government of HKSAR
SN080347 SN080348 SN080349 SN080350
GE Healthcare Mobile Fluoroscopy X-Ray System OEC Model 7600 AND 7700 Linemaster Wireless Footswitch Accessory (Model SP-9970214005112010 and SP-9970214-005112232) Smith & Nephew Exu-Dry Wound Burn Dressing Stryker VertePort 10G Access Cannula w/Long Stylet System, 10G Cement Cannula, 10G Access Canula (short) and 11 G Cement Cannula Abbott CELL-DYN 1800 System with CELL-DYN 22 Calibrators and the CELL-DYN Calibrators abd CELL-DYN 16 Controls (Part # 07H77-01) ALN IVC Filter (Lot: 0107A, 0207A, 0207B, 0307A & 0407A) GE Heatlhcare Advantx-E, Innova 2000, 2100IQ, 3100/3100IQ AND 4100/4100IQ ASTRA PEP/RMT Products (Prodtuct Ref 71001, 71002, 71006, 71007, 71042 and 71052) Jenx Bee Chair AKW 2000 Series Seats Olympus AU2700 Clinical Chemistry Analyser (Models : ALL; Serial: ALL) BIO-RAD ScanGel Sidhil Millennium Freedom Bed (Product Code(s) 1262, 1263, 1263/LOW) Arcomedical 3100-J (FSB499) Burette Set (Batch N1068) Trulife Heel & Elbow and the Heel & Ankle Gelbodies Etac Patient Turner (Model 411973300) Medtronic LIFEPAK 1000 Cryocath FlexCath Steerable Sheath(Ref 3FC12) American Medical Systems GreenLight HPS System (Part No. 0010-0070 and 0010-0075) Gambro cartridge blood set with Phoenix Hemodialysis System Draeger TI500 Isolette Infant Incubator (Catalog no.: MU20505), GT500 Globe Trotter Transport System (Catalog no.: MU20508) and Globe Trotter IC (Catalog no.: MU20509) Smith & Nephew CALAXO Bioabsorbable Interference Screw
FDA FDA FDA
Z-0716-2008 to Z-0717-2008 Z-0933-2008 Z-1199-2008 to Z-1217-2008 Z-1192-2008 to Z-1195-2008
Class II Class II Class II Class II
2008/03/25 2008/03/25 2008/03/25 2008/03/25
GE Medical Systems Hong Kong Ltd. N/A Smith & Nephew Healthcare Ltd. Stryker China Ltd
2783 1838 N/A 2648 7700 2518 6988
FDA
SN080351 SN080352 SN080353 SN080354 SN080355 SN080356 SN080357 SN080358 SN080359 SN080360 SN080361 SN080362 SN080363 SN080364 SN080365 SN080366 SN080367 SN080368
FDA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA Medtronic International Ltd Cryocath Technologies Inc. FDA FDA FDA
Z-0455-2008 2007/012/012/401/002 2008/002/026/061/016 2008/002/027/291/003 2008/002/001/301/001 2007/009/017/601/005 2008/003/003/291/003 2008/003/004/061/009 2007/010/031/061/007 2008/003/012/291/012 MDA/2008/013 MDA/2008/018 N/A N/A Z-0130-2008 Z-1367-2008 Z-1051-2008 to Z-1053-2008 Z-0593-2008 to Z-061612008
Class II FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA MDA MDA Firm Initiated Field Action Firm Initiated Field Action Class II Class II Class II Class II
2008/03/25 2008/03/25 2008/03/26 2008/03/26 2008/03/26 2008/03/26 2008/03/26 2008/03/26 2008/03/26 2008/03/26 2008/03/26 2008/03/26 2008/03/26 2008/03/26 2008/03/27 2008/03/27 2008/03/27 2008/03/27
Abbott Laboratories Ltd. N/A Siemens Ltd. N/A N/A N/A Olympus Hong Kong Ltd Bio-Rad Pacific Ltd. N/A N/A N/A N/A Medtronic International, Ltd. Cryocath Technologies Inc. N/A Gambro China Ltd Draeger Medical Hong Kong Ltd. Smith & Nephew Healthcare Ltd.
2806 4021 N/A 2810 7533 N/A N/A N/A 2376 1805 2789 3300 N/A N/A N/A N/A 2919 1300 N/A N/A 2576 2688 2877 3077 2648 7700
FDA
Medical Device Control Office
71
Department of Health The Government of HKSAR
SN080369 SN080370 SN080371 SN080372 SN080373 SN080374 SN080375 SN080376 SN080377 SN080378 SN080379 SN080380 SN080381 SN080382 SN080383 SN080384 SN080385 SN080386 SN080387 SN080388 SN080389 SN080390 SN080391
Siemens Magnetom Harmony Mobile MRI System, Magnetom Harmony syngo , Magenetom Symphony Magnetom Sonata syngo and Magnetom Symphony syngo Abbott Clinical Chemistry Creatine Kinase (Model LN 7D63-30) Stryker Orthopaedics, UHR Universal Bipolar Component, Hip Prosthesis Component Stryker Orthopaedics Locking Screw T7 (Catalog no 40-27622) Ventana Image Analysis Ssystem (VIAS) PATHWAY anti-HER2/neu (4B5) primary antibody with software version 2.3.0.2 (Model no. VIAS-799-10000-00) Bausch and Lomb Non-Sterile Multiple-use Phaco needles Boston Scientific COGNIS CRT-D device Osypka Medical External Dual Chamber Pluse Generator PACE 203H Volker Nursing Beds (Models 3010 and 5020) Linet Hospital beds Eleganza Standard, Smart and Deluxe models Smiths Medical CADD-MS 3 Ambulatory Infusion Pump (Model 7400, Recorder No 21-7401-54 and 21-7411-51) Philips Brilliance CT Systems Philips Carevue Chart Release C v C.00.00-06 and Intellivue Clinical Info Portfolio D Steris Tenzor Carbon Fiber Orthopedic Traction Steris C1160 Tray used with Steris System 1 Steris Amsco Remanufactured Prevacuum Sterilizers Smiths Medical Flo-2 kit With Mask Radiometer Medical ABL80'S With Software Version 1.10 International Technidyne Corp Avoximeter 1000E Oximeter Maquet Jostra Heater-Cooler Unit 30 System Biosense Webster Navistar RMT Diagnostic/Ablation Catheter Popper And Sons Perfektum Toomey Evacuating Syringe Tomotherapy Hi-Art System
FDA FDA FDA FDA FDA Bausch and Lomb Boston Scientific Hong Kong Ltd MHRA MHRA MHRA MHRA Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada
Z-1042-2008 to Z-1049-2008 Z-1109-2008 Z-0621-208 to Z-0656-2008 Z-1297-2008 Z-0571-2008 N/A N/A 2008/002/022/401/004 MDA/2008/020 MDA/2008/021 2008/002/026/291/005 39694 41242 41089 41078 41256 41199 38880 41136 41072 41193 40097 41091
Class II Class II Class II Class II Class II Firm Initiated Field Action Firm Initiated Field Action FSCA MDA MDA MDA Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II
2008/03/27 2008/03/27 2008/03/27 2008/03/27 2008/03/27 2008/03/27 2008/03/27 2008/03/28 2008/03/28 2008/03/28 2008/03/28 2008/03/31 2008/03/31 2008/03/31 2008/03/31 2008/03/31 2008/03/31 2008/03/31 2008/03/31 2008/03/31 2008/03/31 2008/03/31 2008/03/31
Siemens Ltd. Abbott Laboratories Ltd. Stryker China Ltd Stryker China Ltd N/A Baush and Lomb Boston Scientific Hong Kong Ltd N/A N/A N/A Goodman Medical Supplies Ltd Philips Electronics Hong Kong Ltd. Philips Electronics Hong Kong Ltd. Swedish Trading Co., Ltd Swedish Trading Co., Ltd Swedish Trading Co., Ltd N/A N/A N/A Maquet Hong Kong Ltd N/A N/A TomoKnife (Hong Kong) Ltd
2810 7533 2806 4021 2518 6988 2518 6988 N/A 2213 3371 2960 7128 N/A N/A N/A 2332 4455 2876 7525 2876 7525 N/A N/A N/A N/A N/A N/A N/A N/A N/A 2609 0974
Medical Device Control Office
72
Department of Health The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts -February 2008
Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. Description of Product No. SA080201 SA080202 Organogenesis Apligraf, interactive wound and burn dressing (Lot # GS0711.20.01.2A and GS0711.22.01.2A) Fertility Technology Resources Tucker Embryo Catheter and Morton IUI Catheter Source of Information FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA Health Canada MHRA MHRA MHRA MHRA MHRA Reference No. by Source Z-0675-2008 Z-0662-2008 to Z-0667-2008 Z-0592-2008 Z-0552-2008 Z-0542-2008 to Z-0543-2008 Z-0537-2008 to Z-0541-2008 Z-0258-2008 Z-0120-2008 Z-0115-2008 Z-0434-2008 to Z-0435-2008 Z-0551-2008 Z-0127-2008 Z-0529-2008 40047 2008/001/024/291/004 2008/001/024/601/003 2008/001/014/291/020 2008/001/021/601/002 2007/011/019/291/011 Alert Type by Source Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Type II FSCA FSCA FSCA FSCA FSCA Date of Issue (YYYY/MM/DD) 01-Feb-08 01-Feb-08 01-Feb-08 01-Feb-08 01-Feb-08 01-Feb-08 01-Feb-08 01-Feb-08 01-Feb-08 01-Feb-08 01-Feb-08 01-Feb-08 01-Feb-08 04-Feb-08 04-Feb-08 04-Feb-08 04-Feb-08 04-Feb-08 04-Feb-08 Local Agent N/A N/A N/A N/A N/A N/A N/A N/A Goodman Medical Supplies Ltd Johnson & Johnson Medical Hong Kong Abbott Laboratories Ltd. Abbott Laboratories Ltd. N/A Sanko Medical System (HK) Ltd Philips Electronics Hong Kong Ltd. Abbott Laboratories Ltd. Stryker China Ltd Siemens Ltd. Roche Diagnostics (Hong Kong) Limited Agent Contact Telephone No N/A N/A N/A N/A N/A N/A N/A N/A 2332 4455 2738 2818 2806 4021 2806 4021 N/A 2384 0688 2876 7525 2806 4021 2518 6988 2810 7533 2485 7510
SA080203 Hoana LifeBed Patient Vigilance System (Model# 010135-01) SA080204 AADCO Rayshield Frame Mounted Overhead X-Ray Barrier VNUS 7F ClosureFAST Catheter (Order# CF7-7-60 and CIF7-7SA080205 100) SA080206 SA080207 Ventana Benchmark, Benchmark XT, Benchmark LT, Discovery and Discovery XT Slide Staining System Intuitive Surgical EndoWrist (Part # 400214-02, 400214-03, 420214-02 and 420214-03)
SA080208 AmniSure ROM Test (Model # FMRT-1) SA080209 SA080210 Biomet Straight Magnum Inserter Handle (REF# or Catalo # S313141) Johnson and Johnson Depuy TK2 Compression Hip Screw Trauma Plate (REF 8315-35-004, 8315-35-104)
SA080211 Abbott Accelerator Device Manager (ADM) (List # 08H74-01) SA080212 Abbott AxSYM AUSAB Reagent Pack (List no.: 3C74-20) SA080213 Superior Oxy Serve II Oxygen Conserving Regulator (Model # MCRB-870-6)
SA080214 Toshiba Aquilion 32, 64, Super 4 and Toshiba 256-Slice Scanner Philips Brilliance Big Bore CT Scanners using software v2.2.1 SA080215 through v2.2.5 SA080216 Abbott AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0 (List # 3D54-08)
SA080217 Stryker Burs SA080218 SA080219 Siemens Urea Nitrogen (BUN) Flex reagent cartridge (DF21) (Lot no. FC8283 and FH8271) Roche COBAS AmpliPrep/ COBAS Taqman & High Pure System/COBAS Taqman 48
Medical Device Control Office
73
Department of Health The Government of HKSAR
SA080220 Corin Cormet Head Trial Size 4/44 SA080221 Stryker Trident PSL and Hemispherical Acetabular Cups SA080222 Respironics Esprit ventilators Intuitive Surgical da Vinci S Surgical System 8mm instrument SA080223 cannula, 8mm Long instrument cannula and 5 mm instrument cannula (Part#:420002-01. 420004-01 and 420011-01) SA080224 Intuitive Surgical da Vinci S Surgical System 5 mm instrument cannula (Part#:420011-01)
MHRA Stryker China Ltd CELKI Medical Company FDA
2008/001/023/291/002 N/A N/A Z-0657-2008 to Z-0659-2008
FSCA Firm Initiated Field Action Firm Initiated Field Action Class II
04-Feb-08 04-Feb-08 06-Feb-08 11-Feb-08
N/A Stryker China Ltd CELKI Medical Company N/A
N/A 2518 6988 2268 9258 N/A
FDA
Z-0669-2008
Class II
11-Feb-08
N/A
N/A
Baxter RenalSoft v.2.0 Patient Management Software Suite - HD SA080225 Module and Baxter Renal Software Suite v3.0 and v3.1 - Renal Link HD Module SA080226 Philips Gemini 16 and 64-slice PET/CT Systems, Gemini GXL 6, 10 and 16 slice PET/CT Systems
FDA
Z-0527-2008 to Z-0528-2008 Z-0461-2008 to Z-0462-2008 Z-0124-2008 Z-0690-2008 to Z-0692-2008 Z-0478-2008 Z-0706-2008 to Z-070-2008 Z-0660-2008 2008/001/031/291/002 2008/001/024/291/003 2008/001/022/301/002 Z-0699-2008 Z-0700-2008 to Z-0705-2008 Z-0934-2008 Z-0710-2008 Z-0738-2008 Z-0135-2008 Z-0948-2008 to Z-0949-2008 Z-0727-2008 2008/002/005/061/014
Class II Class II Class II Class II Class II Class II Class II FSCA FSCA FSCA Class II Class II Class II Class II Class II Class II Class II Class II FSCA
11-Feb-08 11-Feb-08 11-Feb-08 11-Feb-08 11-Feb-08 11-Feb-08 11-Feb-08 12-Feb-08 12-Feb-08 13-Feb-08 18-Feb-08 18-Feb-08 18-Feb-08 18-Feb-08 18-Feb-08 18-Feb-08 18-Feb-08 18-Feb-08 20-Feb-08
Baxter Healthcare Ltd Philips Electronics Hong Kong Ltd. Philips Electronics Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. N/A N/A N/A N/A Ultronics Enterprises Ltd N/A N/A Goodman Medical Supplies Ltd N/A N/A Fresenius Medical Care Asia-Pacific Ltd.
2807 8555 2876 7525 2876 7525 2783 1838 N/A N/A N/A N/A 2764 5208 N/A N/A 2332 4455 N/A N/A 2802 2900
FDA FDA FDA FDA FDA FDA MHRA MHRA MHRA FDA FDA FDA FDA FDA FDA FDA FDA MHRA
SA080227 Philips Page Writer Touch Cardiograph (Model # 860284) SA080228 GE Innova 2100IQ, 3100/3100IQ and 4100/4100IQ Blackstone Hallmark Anterior Cervical Plate System (REF#62SA080229 3140) SA080230 Biomet CC Cruciate Tibial Tray (Product no 141232, 141234) SA080231 Spacelabs Medical, Ultraview Multigas Anaylzer (Model 91518) SA080232 Molnycke Health Care Laparoscopic Cholecysectomy SA080233 Schiller FRED Easy Defibrillator SA080234 Days Healthcare Viper & Viper Plus Powerchairs SA080235 SA080236 Arkray Assure 3 Blood Glucose Test Strips (PRODUCT NO 555050) Biomet Ringloc Instrumentation Impactor Plate (Ref/Part # 31400620 - 31-400623, 31-400626, 31-400628)
SA080237 Inotech Brand Heparin Adsobent (Catalog# HA-1) SA080238 Horizon Cardiology Hemo Monitoring System SA080239 Fresenius Medical Care Optiflux 180NR Advanced Fresenius Polysulfone (Catalog no. 0500318E)
SA080240 Cook THSCF-35-260-3-AUS2 SA080241 Medtronic Kyphon Functional Anesthetic Discography (F.A.D.) Catheter System (Catlog # D014, D01B)
(1) Cook Asia (Hong Kong) Ltd.; (2) (1) 2781 0232; (2) A.R. Burkhill & Sons (Hong Kong) Ltd. 2541 1041 Medtronic International, Ltd. Medtronic International, Ltd. Siemens Ltd. 886-22183-6130 886-22183-6130 2810 7533
SA080242 Medtronic Cardioblate Gemini-s model 49260 SA080243 Siemens Dade Behring BEP III System
Medical Device Control Office
74
Department of Health The Government of HKSAR
SA080244 Care & Independence Systems InChair Sling GE Healthcare InstaTrak 3500 Plus with the Cranial Application for SA080245 Image Guide Surgery GE Healthcare Clinical Information Centre (CIC) Pro v5.0.3 and SA080246 5.0.6 SA080247 SA080248 SA080249 SA080250 SA080251 SA080252 Abbott Comfort T-handle Hudson Connector with Impactor Cap (Part # 1006-1) Siemens Mevatron KD2 Medical Charged-Particle Radiation Therapy System Roche LIPC Lipase Colorimetric Reagent (Catalog No.: 03029590322) Varian VARiS 1.4g; Linear Accelerator with RTP Exchange v6.2, v6.6 and v8.0 (Models : ALL) Hamilton Sample Carriers for the ML STAR line (SMP-CAR-24) (Product Code: 866.2500; Part No. 173400) Rockwell Medical RenalPure Liquid Acid Concentrate R-006, R-235 and R-259 ; Glacial Acidic Acid and Dri-Sate Glacial Acidic Acid
MHRA MHRA MHRA FDA FDA FDA FDA FDA FDA MHRA MHRA MHRA MHRA MHRA FDA MHRA MHRA MHRA Bausch and Lomb FDA FDA FDA FDA MHRA FDA
2007/004/030/261/002 2008/002/011/061/008 2008/002/006/601/033 Z-0880-2008 Z-0677-2008 to Z-0687-2008 Z-0688-2008 Z-0718-2008 Z-0718-2008 Z-0871-2008 to Z-0875-2008 2008/002/011/061/011 2008/002/020/061/008 2008/002/006/291/001 2008/002/012/061/007 2008/002/013/061/004 N/A 2008/002/012/061/008 2008/002/015/061/001 2008/002/014/601/063 N/A N/A Z-0850-2008 to Z-0852-2008 Z-0732-2008 Z-0731-2008 MDA/2008/008 Z-0581-2008 to Z-0584-2008
FSCA FSCA FSCA Class II Class II Class II Class II Class II Class II FSCA FSCA FSCA FSCA FSCA Press Release FSCA FSCA FSCA Firm Initiated Field Action Press Release Class II Class II Class II MDA Class II
20-Feb-08 21-Feb-08 21-Feb-08 22-Feb-08 22-Feb-08 22-Feb-08 22-Feb-08 22-Feb-08 22-Feb-08 22-Feb-08 22-Feb-08 22-Feb-08 22-Feb-08 22-Feb-08 26-Feb-08 27-Feb-08 27-Feb-08 27-Feb-08 27-Feb-08 29-Feb-08 29-Feb-08 29-Feb-08 29-Feb-08 29-Feb-08 29-Feb-08
N/A GE Medical Systems Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. Abbott Laboratories Ltd. Siemens Ltd. Roche Diagnostics (Hong Kong) Limited Varian Medical Systems Pacific Inc. N/A N/A N/A N/A Roche Diagnostics (Hong Kong) Limited Philips Electronics Hong Kong Ltd. Philips Electronics Hong Kong Ltd. N/A Philips Electronics Hong Kong Ltd. Medtronic International, Ltd. N/A Baush and Lomb Baxter Healthcare Ltd Siemens Ltd. Siemens Ltd. Carestream Health Hong Kong Limited N/A N/A
N/A 2783 1838 2783 1838 2806 4021 2810 7533 2485 7510 2724 2836 N/A N/A N/A N/A 2485 7510 2876 7525 2876 7525 N/A 2876 7525 886-22183-6130 N/A 2213 3371 2807 8555 2810 7533 2810 7533 2564 9759 N/A N/A
SA080253 ConMed Electrosurgical blades and Needles SA080254 Unipath SmartCheck INR POC Meter and Consumables SA080255 Roche Accu-Chek inform Base Unit Serial Number - UJ33XXXXXX SA080256 Philips General X-Ray System SA080257 Philips X-Ray System Types Omni Diagnost Eleva Chattem Icy Hot Heat Therapy Air Activated Heat adhesive heating SA080258 patch - (i) Back; (ii) Arm, Neck, and Leg SA080259 Philips Easy Diagnost Eleva family, Easy Diagnost Classic family and Diagnost 76 plus family
SA080260 Medtronic Internal Defrillation Handles and Electrodes SA080261 Baxa Corporation EM4200 Exacta-Mix Compounder Operating Software V1.05, 1.06 & 1.06.1
SA080262 Bausch and Lomb Stellaris Vision Enhancement System Baxter Heparin Sodium Injection multi-dose, single dose vials and SA080263 HEP-LOCK heparine flush products (lots: ALL) Siemens Primus Linear Accelerator System and Mevatron Linear SA080264 Accelerator Systems Siemens Syngo Imaging System with VB30A version of software (Model No. 10014063) Kodak DirectView Model DR 3000 System, Stationary X-Ray SA080266 System Hill-Rom Avantguard 1200 and 1400 with manually operated lockSA080267 out function SA080265 SA080268 Hill-Rom Affinity Birthing Bed (Model P3600, P3700A, P3700B)
Medical Device Control Office
75
Department of Health The Government of HKSAR
Intuitive Surgical daVinci S Surgical System (Model No. IS2000) SA080269 and Surgical Endoscopic Instrument Control System (Model No IS2000) Intuitive Surgical daVinci S Surgical System, Endoscopic SA080270 Instrument Control System (Model No IS2000) with Isolation Transformer and Vision Cart (Model VS1000 and VS2000) SA080271 Nova EZ CHEM Creatinine Meter, Control Solution and Linearity Solution
FDA
Z-0079-2008
Class II
29-Feb-08
Chindex
2892 0301
FDA
Z-0151-2008 to Z-0152-2008 Z-0724-2008 to Z-0726-2008 2008/002/019/063/003 2008/002/020/061/007 2008/002/006/061/001 2008/002/019/061/020 2007/010/031/061/010
Class II Class II FSCA FSCA FSCA FSCA FSCA
29-Feb-08 29-Feb-08 29-Feb-08 29-Feb-08 29-Feb-08 29-Feb-08 29-Feb-08
N/A N/A Philips Electronics Hong Kong Ltd. Philips Electronics Hong Kong Ltd. Stryker China Ltd Philips Electronics Hong Kong Ltd. Johnson & Johnson Medical Hong Kong
N/A N/A 2876 7525 2876 7525 2518 6988 2876 7525 2738 2818
FDA MHRA MHRA MHRA MHRA MHRA
SA080272 Philips Digital Diagnost Family SA080273 Philips EasyVision RAD Stryker Gamma 3 Set Screwdriver, 4mm Flexible Shaft (Catalog No SA080274 1320-0231) SA080275 Philips Digital Diagnost family, Bucky Diagnost family, Easy Diagnost family, Thoravision
SA080276 Depuy polyethylene knee bearings
Medical Device Control Office
76
Department of Health The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts -January 2008
Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. No. SA080101 SA080102 SA080103 SA080104 SA080105 SA080106 SA080107 SA080108 SA080109 SA080110 SA080111 SA080112 SA080113 SA080114 SA080115 SA080116 SA080117 SA080118 SA080119 SA080120 SA080121 SA080122 Description of Product Medtronic CD Horizon Agile Dynamic Stabilization Device Smiths Medical Graseby 500 and 505 volumetric infusion pumps (Models: ALL) Medtronic Satellite Spinal System, Satellite Sphere CoCr, Satellite System Sphere PEEK and Material Stainless Steel/Radel Roche Ammonia/Ethanol/CO2 Calibrator, Control N (Normal) and Control A (Abnormal) (Catalog no. 20751995190, 20752401190, 20753009190) Rita Medical Vortex VX Port System (REF/Part no.: P5455K; Catalog No.: P5455, Latex Free, Sterile) Ellex Eye Cubed, I 3 System-ABD Ultrasound Version 3.0 with Software Version 3.0 and Biometry A-Scan modality Precept Medical Products Tape Fog Shield Surgical Mask Green Fiberglass Free and Foam Fog Shield Surgical Mask Green Fiberglass Free (Reorder#65-3322 and 65-3320) Microbiologics P.vulgaris, DuoPacksI (Product Catalog # 0691P, ARCC 0427; Exp 2008-9) BatteryZone Life+cel (OEM P/N 9146-001 and 9141-001 ; Part # 7L877 and 2L561) Hill-Rom SM647 Medical Charis and SM608 Relaxation Chairs (Serial no HRP000698167 - HRP000733692) Philips Digital Diagnost Family ThermoFisher Scientific DADE Cardiac TL Assayed Cardiac Marker Control Horcher Lifting System Powered Patient Positioner Select Healthcare DUO Transfer Slide Deluxe and Duo Transfer Slide (Model LOCO-400A and LOCO-410A) Smiths Medical CADD Medication Cassette Reservoirs (Recorder No.: 21-7002-24, 21-7001-24, 21-7100-24) ProTime Microcoagulation System PROTIMEINT Stryker Distal Depth Screw Guage (Catalog. no. 12146000, LOT/BATCH NO:K532495) Stryker Stretchers (Model No.: 660, 721, 735, 1001, 1002, 1005, 1015, 1020, 1069) Fresenius Medical Care multiFiltrate acute dialysis system BD 5ml and 10ml Syringe Luer Lok Tip, Bulk, Sterile Convenience Paks bioMerieux, BacT/ALERT FA Culture Bottles (Lot no 1017685, 101793 and 1017788) Abbott CELL-DYN Sapphire Hemoglobin Reagent Analyzer Syringes (List no 08H49-02) Source of Information MHRA MHRA FDA FDA FDA FDA FDA FDA FDA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA BD FDA FDA Reference No. by Source 2007/011/013/061/020 MDA/2007/100 Z-0192-2008 to Z-0210-2008 Z-0377-2008 to Z-0379-2008 Z-0149-2008 Z-0148-2008 Z-0153-2008 to Z-0154-2008 Z-0456-2008 Z-0523-2008 to Z-0524-2008 2007/012/006/061/016 2007/009/006/401/002 2007/012/018/051/002 2007/007/010/401/004 2007/008/006/401/005 2007/012/018/051/001 2007/011/028/291/005 2007/011/027/061/012 2007/012/013/061/010 2007/012/017/051/003 N/A Z-0457-2008 Z-0301-2008 Alert Type by Source FSCA MDA Class II Class II Class II Class II Class II Class II Class II FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA Firm Initiated Field Action Class II Class II Date of Issue (YYYY/MM/DD) 2008/01/02 2008/01/02 2008/01/03 2008/01/03 2008/01/03 2008/01/03 2008/01/03 2008/01/03 2008/01/03 2008/01/07 2008/01/07 2008/01/07 2008/01/07 2008/01/07 2008/01/09 2008/01/09 2008/01/09 2008/01/09 2008/01/09 2008/01/09 2008/01/11 2008/01/11 Local Agent Medtronic International, Ltd. Smiths Medical (S.E. Asia) Ltd. Medtronic International, Ltd. Roche Diagnostics (Hong Kong) Limited N/A N/A N/A N/A N/A N/A Philips Electronics Hong Kong Ltd. N/A N/A N/A Goodman Medical Supplies Ltd N/A Stryker China Ltd Stryker China Ltd Fresenius Medical Care Asia Pacific Ltd. BD Biomerieux (Hong Kong) Abbott Laboratories Ltd. Agent Contact Telephone No 2919 1362 N/A 2919 1362 2485 7510 N/A N/A N/A N/A N/A N/A 2876 7525 N/A N/A N/A 2332 4455 N/A 2518 6988 2518 6988 N/A 2575 8668 2356 7033 2806 4201
Medical Device Control Office
77
Department of Health The Government of HKSAR
SA080123 SA080124 SA080125 SA080126 SA080127 SA080128 SA080129 SA080130 SA080131 SA080132 SA080133 SA080134 SA080135 SA080136 SA080137 SA080138 SA080139 SA080140 SA080141 SA080142 SA080143 SA080144 SA080145 SA080146 SA080147 SA080148
Siemens IMMULITE/IMMULITE 1000, IMMULITE 2000 and IMMULITE 2500 Operators Siemens Syva Emit II Plus Amphetamines Assay (Catalog No 9C039ul, Lot Z10) Smith & Nephew Wrist Stabilization Kit (Part # 7691, 7692, 7693 ; Lot # 20060605) Fresenius Kabi Orchestra Base Primea AMO VISX STAR excimer laser chair Stephan Neonatel Transport Ventilator BD FACSDiva software v6.0 and 6.1 with the HP XW4400 Computer System Fannin GU Fibrillator Unit 3821 Datascope CS 100 Intro-Aortic Balloon Pump and CS 300 IntraAortic Balloon Pump Boston Scientific Stainless Steel Greenfield Vena Cava Filter Boston Scientific Slimline 200 Micron Delivery System Boston Scientific Galaxy 2 and ClearView Systems Boston Scientific ICD and CRT-D devices implanted subpectorally with the serial number facing the ribs Siemens Biograph 6, 16, 40-3 Ring, 40 TruePoint, 64-3 Ring and DUO LSO Johnson and Johnson CORDIS FireStar and Dura Star RX PTCA Dilatation Catheters Abbott ARCHITECT i System Assay CD-ROM-WW (List No. (LN) 6E59) Ventena Medical System's Symphony Staining System, KPA (Model # : 2200000; catalog# 900-SYM1 and 900-SYM3) Toshiba Aplio XG Diagnostic Ultrasound System (Model: SSA-790A with version 1.1 software) Encore Medical VariLift Bone Plug w/ End Cup Siemens ACUSON Antares, Ultrasound System Oasis Medical PremierEdge MICROSURGICAL KNIFE Fisher and Paykel Healthcare Cosycot UPS Siemens ADVIA Centaur and ADVIA Centaur XP Immunoassay Systems VacSax and GelSax Disposable Suction Liners Baxter Healthcare Home Choice Automated PD System and Home Choice Pro Automated PD System Baxter Healthcare Infusor 2mL/HR
MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd FDA Johnson & Johnson Medical Hong Kong FDA FDA FDA FDA FDA FDA MHRA MHRA MHRA Health Canada Health Canada
2008/001/004/601/001 2008/001/003/601/002 2007/012/020/061/001 2008/001/007/061/010 2008/001/004/061/010 2007/012/007/061/002 2008/001/008/061/012 2008/001/009/291/003 2008/001/009/291/002 N/A N/A N/A N/A Z-0247-2008 to Z-0252-2008 N/A Z-0299-2008 Z-0300-2008 Z-0305-2008 Z-0306-2008 to Z-0311-2008 Z-0297-2008 to Z-0298-2008 Z-0485-2008 to Z-0516-2008 2007/005/010/401/004 2008/001/003/291/003 2007/011/023/401/002 39272 39388
FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA Firm Initiated Field Action Firm Initiated Field Action Firm Initiated Field Action Firm Initiated Field Action Class II Firm Initiated Field Action Class II Class II Class II Class II Class II Class II FSCA FSCA FSCA Type II Type II
2008/01/14 2008/01/14 2008/01/14 2008/01/14 2008/01/14 2008/01/15 2008/01/15 2008/01/15 2008/01/15 2008/01/16 2008/01/16 2008/01/16 2008/01/16 2008/01/16 2008/01/16 2008/01/17 2008/01/17 2008/01/17 2008/01/17 2008/01/17 2008/01/17 2008/01/17 2008/01/17 2008/01/17 2008/01/18 2008/01/18
Siemens Ltd. Siemens Ltd. Smith & Nephew Healthcare Ltd. N/A THI Holdings Inc. N/A BD N/A Datascope Corp Asia-Pacific Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd Siemens Ltd. Johnson & Johnson Medical Hong Kong Abbott Laboratories Ltd. N/A N/A N/A Siemens Ltd. N/A Tokibo Co. (HK) Ltd. Siemens Ltd. Goodwin Health Care Ltd Baxter Healthcare Ltd Baxter Healthcare Ltd
2810 7533 2810 7533 2645 8703 N/A
N/A 2575 8668 N/A 2647 9713 2960 7128 2960 7128 2960 7128 2960 7128 2810 7533 2738 2818 2806 4021 N/A N/A N/A 2810 7533 N/A 2418 9698 2810 7533 2408 8838 2807 8555 2807 8555
Medical Device Control Office
78
Department of Health The Government of HKSAR
SA080149 SA080150 SA080151 SA080152 SA080153 SA080154 SA080155 SA080156 SA080157 SA080158 SA080159 SA080160 SA080161 SA080162 SA080163 SA080164 SA080165 SA080166 SA080167 SA080168 SA080169 SA080170 SA080171 SA080172 SA080173 SA080174 SA080175 SA080176
BD difco Shigella antiserum poly groupb BD vacutainer push button blood collection sets with pre-attached holder (Model# 367352, 368656) BD Calibrite APC Beads (Model # 340487) Philips Medical Allura XPER FD20 System (S/N 297) Philips Medical BV Endura and BV Pulsera (Model# MMC 2011, MMC 2011) Varian RPM Respiratory Gating System Roche Diagnostics Coagucheck XS PT strips 2x24, 24,6 tests (Model#4625315017, 4625358017, 4625374190) Bio-Rad Amplicheck Swab CT/GC Control A positif (Model # 133, 133X) Cardinal Health Medley Pump Module (Model 8100LVP) Henry Schien Mirror Defogger (Model# 1000459, 17-20902) M.C. Healthcare Maxxum Hi/Lo Bed BHM Medical 1000LB Scale, 300KG,Class 3 Scales, 800 LB Scale, Ergolift with Scale St. Jude Medical Epic, Atlas and Convert Family of ICDs Smith & Nephew Universal Hip Extractors (Part No. 72200626) Philips M3170 IntelliVue Patient Link running software versions J.00.23, J.00.24, J.00.25 and J.00.26 Abbott CELL-DYN 4000 and CELL-DYN Sapphire WBC Reagent (Part A, List # 01H77-01) Datascope Panorama Patient Monitoring Network, Panorma Telepack 608 Sechrist Hyperbaric Chanmber Curney Siemens ADVIA Centaur and ADVIA Centaur XP Immunoassay Systems Alcon Ophthalmic Procedure Pack Wescor Osmocoll SS-025, SS-038 and SS-039 Medtronic Synchromed EL, Synchromed II and IsoMed drug infusion pumps ev3 IntraStent Unmounted Balloon Expandable Stents Chattanooga Electrotherapy Devices (Intelect and Vectra Series) Lombard Medical Aorfix Stent Grafts Dixons Tudor Edwards Double Rib Cyberonics VNS Therapy Lead Model 302 BD FACS Sample Prep Assistant II instruments
Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada St. Jude Medical MHRA MHRA MHRA FDA FDA MHRA MHRA MHRA Medtronic International Ltd MHRA MHRA MHRA MHRA MHRA MHRA
39695 39405 39352 39575 39582 39358 39425 39423 39408 39386 39652 39427 N/A 2008/001/004/061/003 2008/001/011/061/026 2007/012/024/601/003 Z-0150-2008 Z-0733-2008 to Z-0737-2008 2008/001/017/291/012 2008/001/004/061/006 2008/001/017/291/013 N/A 2008/001/011/291/003 2007/012/020/061/019 2008/001/017/291/011 2008/001/017/601/001 2008/001/002/061/002 2007/010/002/061/013
Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Firm Initiated Field Action FSCA FSCA FSCA Class II Class II FSCA FSCA FSCA Firm Initiated Field Action FSCA FSCA FSCA FSCA FSCA FSCA
2008/01/18 2008/01/18 2008/01/18 2008/01/18 2008/01/18 2008/01/18 2008/01/18 2008/01/18 2008/01/18 2008/01/18 2008/01/18 2008/01/18 2008/01/18 2008/01/21 2008/01/21 2008/01/21 2008/01/24 2008/01/24 2008/01/24 2008/01/24 2008/01/24 2008/01/24 2008/01/28 2008/01/28 2008/01/28 2008/01/28 2008/01/28 2008/01/28
BD BD BD Philips Electronics Hong Kong Ltd. Philips Electronics Hong Kong Ltd. Varian Medical Systems Pacific Inc. Roche Diagnostics (Hong Kong) Limited Bio-Rad Pacific Ltd. N/A N/A N/A N/A St. Jude Medical Smith & Nephew Ltd. Philips Electronics Hong Kong Ltd. Abbott Laboratories Ltd. Datascope Corp Asia-Pacific N/A Siemens Ltd. Alcon Hong Kong Ltd N/A Medtronic International, Ltd. Conmed Limited N/A N/A N/A GM Medical BD
2575 8668 2575 8668 2575 8668 2876 7525 2876 7525 2724 2836 2485 7510 2789 3300 N/A N/A N/A N/A N/A N/A 2876 7525 2806 4021 2647 9713 N/A 2810 7533 2568 0636 N/A 2891 4456 2854 4413 N/A N/A N/A N/A 2575 8668
Medical Device Control Office
79
Department of Health The Government of HKSAR
SA080177 SA080178 SA080179 SA080180 SA080181
Stryker V40 Femoral Heads Johnson and Johnson STERRAD Sterilizer System (50, 100S, 200 and NX Sterilizers) Medtronic Model 8870 N'Vision Clinican Programmer Software Application Card Biosite Triage Micro C. Difficile Panel (Catalog no 96000) AM2 PAT Inc Pre-Filled Heparin Lock Flush Syringes and Normal Saline IV Flush Syringes (All Lots and All Sizes)
MHRA MHRA MHRA MHRA FDA
2008/001/016/121/001 2007/012/004/061/009 2008/001/003/291/014 2008/001/017/291/003 N/A
FSCA FSCA FSCA FSCA Class I/Press Release
2008/01/30 2008/01/30 2008/01/30 2008/01/30 2008/01/31
Stryker China Ltd Johnson & Johnson Medical Hong Kong Medtronic International, Ltd. N/A N/A
2518 6988 2738 2818 2891 4456 N/A N/A
Medical Device Control Office
80
Department of Health The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts -December 2007
Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. No. SA071201 SA071202 SA071203 SA071204 SA071205 SA071206 SA071207 SA071208 SA071209 SA071210 SA071211 SA071212 SA071213 SA071214 SA071215 SA071216 SA071217 SA071218 SA071219 SA071220 SA071221 SA071222 SA071223 SA071224 SA071225 SA071226 Description of Product Medtronic Bravo pH capsule with delivery system (Proudct Numbers 9012B1011 and 9012B1001) Philips Brilliance or MX8000Dual v.EXP CT Couch Vital PET/CT Visualization option available in ViTALConnect Version 4.0 and 4.1 ZOLL LifeVest WCD3000 Battery Pack Draeger Medical Anaesthetic Gas Scaverging System (AGSS) receiver Procare Privac set (Product code 24760) Stryker V40+ 16mm Offset Femoral Heads and associated Femoral Head Trails Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis System Ohio Willow Wood Alpha Original Locking Liners (ALL-X0XX / ALLX1XX / ALL-X2XX) Steering Developments Lifestyle JW1, JWII and JWX1 Wheelchair Power Assist System VIASYS Infant Flow SiPAP Paediatric Respiratory Support Device MI Tech Hanarostent Anti Reflux and Choostent Sunrise Medical Little Gem 2 Movingpeople.net Beatle Y.e.S. Philips MD Eleva Flat Detector (Ref XDB087-070515/BW) Stryker UHR Universal Head Bipolar Component Terumo Integrated Centrifugal System Control Unit (Model 801046, Lot: 0049, 0079) Terumo Ultrasonic Air Sensor (Model: 5773, 5785, 5791) Philips M3170 Intellivue Patient Link (Model: M3170, LOT: S/A 4721A01711) Smith & Nephew Genesis II femoral sets Depuy PFC Sigma Knee System - ALL Polyethlen, PS RP Bearing, Stabilized TIBI and Preservation Unicondylar Knee -ALL POL Abbott AxSYM Gentamicin and TDx/TDxFLx Gentamicin (Model 7A65-20 and 9512-60) Radiometer Pump tubes for ABL800 Series (Model: 842-326, 842327, 842-328, 902-754, 905-671) Sigma 8002 Dual Channel Infusion Pump (Model 35061) Toshiba Asteion M/S4, Asteion S/S (Mode TSX-021A) Toshiba-Interventional Angiography System, Infinix i (Model DFP8000D) Source of Information Medtronic International, Ltd. MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada FDA Reference No. by Source N/A 2007/010/029/061/017 2007/011/022/061/010 2007/011/026/061/018 MDA/2007/090 MDA/2007/091 2007/011/026/061/011 2007/011/030/061/012 2007/008/013/051/014 2007/006/022/261/001 MDA/2007/093 2007/008/014/061/009 2007/011/016/301/002 2007/005/003/401/001 2007/011/030/061/010 2007/011/027/061/002 38444 39116 38975 39055 38472 38915 38840 37977 38921 Z-0293-2008 Alert Type by Source Firm Initiated Field Action FSCA FSCA FSCA MDA MDA FSCA FSCA FSCA FSCA MDA FSCA FSCA FSCA FSCA FSCA Type II Type II Type II Type II Type II Type II Type II Type II Type II Class II Date of Issue (YYYY/MM/DD) 2007/12/03 2007/12/04 2007/12/04 2007/12/04 2007/12/05 2007/12/05 2007/12/06 2007/12/06 2007/12/06 2007/12/06 2007/12/07 2007/12/07 2007/12/07 2007/12/07 2007/12/07 2007/12/07 2007/12/10 2007/12/10 2007/12/10 2007/12/10 2007/12/10 2007/12/10 2007/12/10 2007/12/10 2007/12/10 2007/12/10 Local Agent Medtronic International, Ltd. Philips Electronics Hong Kong Ltd. N/A N/A Draeger Medical Hong Kong Ltd. N/A Stryker China Ltd Baxter Healthcare Ltd N/A N/A Viasys Healthcare Hong Kong Ltd N/A N/A N/A Philips Electronics Hong Kong Ltd. Stryker China Ltd Terumo China (H.K.) Ltd. Terumo China (H.K.) Ltd. Philips Electronics Hong Kong Ltd. Smith & Nephew Ltd. DePuy Inc (J&J) Abbott Laboratories Ltd. N/A N/A Sanko Medical System (HK) Ltd Sanko Medical System (HK) Ltd Agent Contact Telephone No 2919 1362 2876 7525 N/A N/A 2877 3077 N/A 2518 6988 2807 8555 N/A N/A 2891 8730 N/A N/A N/A 2876 7525 2518 6988 2866 0811 2866 0811 2876 7525 2648 7700 2738 2894 2806 4021 N/A N/A 2384 0688 2384 0688
Medical Device Control Office
81
Department of Health The Government of HKSAR
SA071227 SA071228 SA071229 SA071230 SA071231 SA071232 SA071233 SA071234 SA071235 SA071236 SA071237 SA071238 SA071239 SA071240 SA071241 SA071242 SA071243 SA071244 SA071245 SA071246 SA071247 SA071248 SA071249 SA071250 SA071251
Medtronic 0-arm Imaging System (Product Code B1-700-00027) Zimmer Durom Hip Resurfacing Systems, Femoral Component 54 Code T and 46 Code L (Cat no. 01.00211.154 and 01.00211.146) Edwards Lifesciences LifeStent FlexStar Bilary Stent System Application (Model EX080801CD) Teleflex Pilling Center-Action Forceps with Insulated Shafts (Cat no. 505015, 505039 and 505045) Wright Medical Technology Odyssey Femoral Holder/Driver (Part no. K001-7410) Xoran MiniCAT for ENT Oridion Capnostream20 Monitor with Nellcor Pulse Oximetry Module (Part no. CS08657) and Capnostream20 Monitor with Masiomor Pulse Oximetry Module (Part no. CS08659) Sunrise Medical Sapphire 2 and Sapphire LS 2 Philips Cardiac Viewer and Pulmonary Viewer Application Henry Schein EasyCam Eurolite, Eurolite II and Eurodoc Intra-oral Cameras ConMed Frazier and Poole Suction Intruments (Cat no. 0031030, 0033080, 0033120, 0031100, 0031070, 0033180, 0031050, 0033110, 0035040, 0033100) Roche Elecsys HBsAgII and Elecsys Anti-HBs Siemens Mevatron M2/PRIMUS Plus, Oncor Impresson Plus. Oncor Impression, ONCOR Avante Garde, Mevatron M2 Primus Biomet Orthopedics Vanguard PS Open Femoral (Ref. no.: 183130; Lot no. 395450) Straumann Palatal Implant (Article No. 042.335S and 042.336S) Frenius Kabi Applix Smart pump (all models) CME Mckinley MicroSet NDEHP with 1.2 filter and SR segment (CME Code: 120-112SFV) (Lot no. 2856-7, 3173-7, 3226-7, 33437, 3344-7, 3345-7, 3346-7, 3347-7, 3397-7, 3398-7) Sysmex SF-3000 Haematology Analyser, software version 00-01 on CPSU-4 sampler Radiometer Medical ABL77 Cal Packs Stryker Hipstar V40 Femoral Stem-127 degrees (Cat. No. 7850-5001 - 7850-5-012) Stryker Hipstar TMZF Cementless Hip Stem Protocol (Product no. LSP60) Stryker Triathlon MIS AP Sizer Body-left and Right, Triathlon MIS Femoral Adjustment Block and Triathlon MIS Modular Capture Stryker inTouch Critical Care bed (Model 2130) and Stryker inTouch Zoom Critical Care bed (Model 2140) B. Braun Excia Cemented Hip Stems (Size 9mm to 18mm) Abbott ARCHITECT c8000 Processing Module (List no 106-01) and ARCHITECT c16000 Processing Module (List no 3L77-01)
FDA FDA FDA FDA FDA FDA FDA MHRA MHRA MHRA MHRA MHRA FDA FDA FDA MHRA MHRA MHRA MHRA FDA FDA FDA FDA FDA FDA
Z-0294-2008 Z-0275-2008 to Z-0276-2008 Z-0179-2008 Z-0266-2008 to Z-0268-2008 Z-0290-2008 Z-0296-2008 Z-0177-2008 to Z-0178-2008 2007/010/024/261/001 2007/010/009/261/001 2007/011/030/061/009 2007/011/022/601/005 2007/010/001/291/003 2007/011/008/291/006 Z-0380-2008 to Z-0384-2008 Z-0123-2008 Z-0277-2008 to Z-0278-2008 MDA/2007/098 2007/012/005/061/022 2007/011/005/401/011 2007/009/003/061/009 Z-0463-2008 to Z-0474-2008 Z-0475-2008 Z-0448-2008 to Z-0450-2008 Z-0356-2008 to Z-0357-2008 Z-0436-2008 to Z-0445-2008 Z-0146-208 to Z-0147-2008
Class II Class II Class II Class II Class II Class II Class II FSCA FSCA FSCA FSCA FSCA Class II Class II Class II MDA FSCA FSCA FSCA Class II Class II Class II Class II Class II Class II
2007/12/10 2007/12/10 2007/12/10 2007/12/10 2007/12/10 2007/12/10 2007/12/10 2007/12/11 2007/12/12 2007/12/14 2007/12/14 2007/12/14 2007/12/14 2007/12/14 2007/12/14 2007/12/18 2007/12/19 2007/12/19 2007/12/19 2007/12/20 2007/12/20 2007/12/20 2007/12/20 2007/12/20 2007/12/20
Medtronic International, Ltd. Zimmer PTE Ltd. (Hong Kong branch) N/A N/A Starry Medical Technology Ltd N/A N/A N/A Philips Electronics Hong Kong Ltd. N/A Medisource Roche Diagnostics (Hong Kong) Limited Siemens Ltd. Goodman Medical Supplies Ltd N/A Fresenius Medical Care Asia Pacific Ltd. N/A N/A N/A Stryker China Ltd Stryker China Ltd Stryker China Ltd Stryker China Ltd B. Braun Medical (Hong Kong) Ltd. Abbott Laboratories Ltd.
2919 1362 2992 0968 N/A N/A 2381 0279 N/A N/A N/A 2876 7525 N/A
2485 7510 2810 7533 2332 4455 N/A
N/A N/A N/A 2518 6988 2518 6988 2518 6988 2518 6988 2277 6125 2806 4021
Medical Device Control Office
82
Department of Health The Government of HKSAR
SA071252 SA071253 SA071254 SA071255 SA071256 SA071257 SA071258 SA071259 SA071260 SA071261 SA071262 SA071263 SA071264 SA071265 SA071266 SA071267 SA071268 SA071269 SA071270 SA071271 SA071272 SA071273 SA071274 SA071275 SA071276 SA071277 SA071278
Roche Diagnostics LightCycler Capillaries (100uL) (Catalog # 03337090001, 04391039001, 03603946001, 03531414201) ConMed Accessory Electrode, Universal Electrodes and Ultra Clean Accessory Electrode BD Visitec Nucleus Hydrodissector (Catalog # 585155, 585793) Accuray Multiplan Treatment Planning Software Cardinal Health Alaris Pump modules, model 8100 (Medley Pump modules) Axya Bone Anchor Mizuho OSI Allegro 6800 Imaging Table (Operating) and OSI ProFx Operating Room Table 6850 VNUS ClosureFAST catheters (Model no. CL7-7-100) Zimmer Minimally Invasive Solutions Technology Offset Rasp Handles (REF/Catalog# 7712-35-01 and 7712-35-02) Blackstone Medical Ascent POCTS (Posterior Occipital Cervical Thoracic System) ACIST Multi-Use Syringe Kit (Model A2000; SKU# 014612, Catalog#800061-003) VKS Tibial Trial, Right/Left, Prep Guide Haemonetics cardioPAT System (Product list no 02050) Single Use Surgical Tibbs cannula - S044 all batches Liko Sabina II 350-slingbar (prod no. 2027002) Baxter Infusor 2ml/hr with Tubing Flow Restrictor (Product Code: 2C1071KJP) OPTI LION E-Plus Cassettes(Model: BP7507) Cyberonics VNS Therapy Lead (Model 302) Terumo Artifical vascular graft - Triplex Bayer Contour TS blood glucose test strips Toshiba Aquilion 32 and Aquilion 64 TD-Synergy Software (TD-SYN-01) Instrumentation Laboratory HemosIL RecombiPlasTin and Hemoliance RecombiPlasTin Beckman Coulter Cytomics FC 500 Flow Cytometer and Cytomics FC 500 MPL Beckman Coulter Cytomics FC 500 Flow Cytometer Beckman Coulter Sychron CX Systems salicylate reagent Freedom Designs TriPod w/Anti tipper Manual Wheelchair (Model no.: TriPod, Tripod LT and TriPod Pediatric LT with Trailing AntiTipper-Caster- Axle Link)
FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA MHRA MHRA MHRA MHRA Cyberonics Terumo China (H.K.) Ltd. FDA Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada FDA
Z-0459-2008 Z-0452-2008 Z-0453-2008 to Z-0454-2008 Z-0364-2008 Z-0460-2008 Z-0331-2008 to Z- 0355-2008 Z-0241-2008 to Z-0242-2008 Z-0132-2008 Z-0316-2008 to Z-0317-2008 Z-0363-2008 Z-0359-2008 Z-0362-2008 Z-0358-2008 2007/011/028/601/002 2007/011/021/291/001 2007/012/010/061/003 2007/011/026/061/019 N/A N/A Press Release 39250 39374 39288 39286 37157 39284 Z-0137-2008
Class II Class II Class II Class II Class I Class II Class II Class II Class II Class II Class II Class II Class II FSCA FSCA FSCA FSCA Firm Initiated Field Action Firm Initiated Field Action N/A Type II Type II Type II Type II Type II Type II Class II
2007/12/20 2007/12/20 2007/12/20 2007/12/20 2007/12/20 2007/12/21 2007/12/21 2007/12/21 2007/12/21 2007/12/21 2007/12/21 2007/12/21 2007/12/21 2007/12/21 2007/12/21 2007/12/21 2007/12/21 2007/12/21 2007/12/21 2007/12/21 2007/12/31 2007/12/31 2007/12/31 2007/12/31 2007/12/31 2007/12/31 2007/12/31
Roche Diagnostics (Hong Kong) Limited N/A BD Accuray Asia Ltd N/A N/A N/A N/A Zimmer PTE Ltd. (Hong Kong branch) N/A N/A N/A Haemonetics (Hong Kong) Limited N/A N/A Baxter Healthcare Ltd N/A Cyberonics Terumo China (H.K.) Ltd. Bayer Healthcare Ltd. (Hong Kong) Sanko Medical System (HK) Ltd N/A Beckman Coulter Hong Kong Ltd. Beckman Coulter Hong Kong Ltd. Beckman Coulter Hong Kong Ltd. Beckman Coulter Hong Kong Ltd. N/A
2485 7510 N/A 2575 8668 2247 8688 N/A N/A N/A N/A 2992 0968 N/A N/A N/A 2868 9218 N/A N/A 2807 8555 N/A
2866 0811 2814 7337 2384 0688 N/A 2814 0481 2814 0481 2814 0481 2814 0481 N/A
Medical Device Control Office
83
Department of Health The Government of HKSAR
SA071279
Medtronic Prestige Cervical Disc System, Implant Trial (REF/Catalog#: 6972226, 6972246, 6972266, 6972247, 6972267, 6972287) Gen-Probe Accuprobe Group B Streptococcus Culture Identification Test (Catalog.: 2820B and Batch no.: 531379) Encore Reverse Shoulder Prothesis(RSP) System (Catalog #: 50800-036 and 508-00-040) Ellex Solitarie Opthalmic Laser System (Model no : LP4532-DGS P/N303896; Solitaire-SGS P/N 3038960) and Ellex Integre Duo (Model no. LP1RG-S P/N 3040000) OrthoHelix Surgical Designs DRLock Bone Fixation Plates, Pegs and Screw Systems, Distal Screw and Distal Peg Sultan Brand Mirror Defogger Hudson Action forceps with insulated shafts Span-America Medical Systems Pressureguard Easy Air Mattress
FDA
Z-0138-2008 to Z-0143-2008
Class II
2007/12/31
Medtronic International, Ltd.
2919 1362
SA071280 SA071281 SA071282 SA071283 SA071284 SA071285 SA071286
FDA FDA FDA FDA Health Canada Health Canada Health Canada
Z-0145-2008 Z-0184-2008 to Z-0185-2008 Z-0286-2008 to Z-0287-2008 Z-0136-2008 39364 38922 39236
Class II Class II Class II Class II Type II Type II Type II
2007/12/31 2007/12/31 2007/12/31 2007/12/31 2007/12/31 2007/12/31 2007/12/31
N/A N/A N/A N/A N/A N/A N/A
N/A N/A N/A N/A N/A N/A N/A
Medical Device Control Office
84
Department of Health The Government of HKSAR
Month
Note: FDA F d d MDCO Ref. No. SA071101 SA071102 SA071103 SA071104 SA071105 SA071106 SA071107 SA071108 SA071109 SA071110 SA071111 Description of Product Smith & Nephew, Birmingham Hip Resurfacing Acetabular Cup Remington Medical Disposable Urinary Leg Bags (Order no. 500-D and 1000-D) Philips Heartstart XL Monitor/Defibrillator (Model : M4735A) BD Microkeratome K3000 and K4000 (Cat No. 378660) Steris QFC1728 and QFC1729 Quick Connects Stryker Trident PSL HA Cluster Acetabular Shell and HA solid back acetabular shell Integra Flat Foot Implant KALIX II (Ref141 0xx) Innovacon Strep A Rapid Test Strip and Strep A Rapid Test Device Welch Allyn AED10 Automatic External Defibrillators Beckman Coulter FC500 Flow Cytometry Systems with CXP Acquisition Software and FC500 MPL Cytometry Systems with MXP Acquisition Software Boston Scientific RepliformR Tissue Regenration Matrix Bio-logic System Corp - Telescoping Camera Pole Assembly (part no 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580PNCART, model 580-VIDPOL) Thoratec Implantable Ventricular Assist Devices (Catalogue No.: 10012-2555-001) Roche High Pure System (Product Numbers 03502295001 and 03702995001) GE Healthcare Flexi-DT Mobile Radiographic Table Unomedical umbilical cord clamp clipper (Ref: 84006182) Vernon-Carus Products containing 10x10 16ply X-Ray Detectable Swabs (49335) Terumo Advanced Perfusion System 1 (Model no. 801046, Lot: 0049 AND 0079) Toshiba Aplio XG (SSA-790A) Baxter Healthcare Duoject EASY-Prep System Abbott Aeroset System-Creatine Kinase Assay (Model 7D63-30) Abbott Accelerator APS System Input/Output Module (IOM) (Model: 7L01-01) Siemens Mevatron Linear Accelerators, Oncor Expression Digital Linear Accelerator and Oncor Care Systems Siemens Mevatron Linear Accelerators and Oncor Impression Beckman Coulter Immunoassay Analyzers Source of Information FDA FDA FDA FDA FDA FDA MHRA MHRA FDA MHRA Boston Scientific(HK) Ltd FDA Thoratec Corporation MHRA MHRA MHRA MHRA Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Reference No. by Source Z-0017-2008 to Z-0033-2008 Z-0058-2008 Z-0062-2008 Z-0062-2008 Z-0101-2008 Z-0072-2008 to Z-0073-2008 2007/008/010/061/008 2007/007/019/291/002 N/A 2007/010/026/601/002 N/A Alert Type by Source Class II Class II Class II Class II Class II Class II FSCA FSCA Class I FSCA Firm Initiated Field Action Date of Issue (YYYY/MM/DD) 2007/11/01 2007/11/01 2007/11/01 2007/11/01 2007/11/01 2007/11/01 2007/11/02 2007/11/02 2007/11/05 2007/11/07 2007/11/07 Local Agent Smith & Nephew Ltd. N/A Philips Electronics Hong Kong Ltd. BD Stryker China Ltd N/A N/A Umedco Beckman Coulter Hong Kong Ltd. Boston Scientific (HK) Ltd Agent Contact Telephone No 2648 7700 N/A 2876 7525 2575 8668 2518 6988 N/A N/A 2765 8222 2240 6260 2960 7128
SA071112 SA071113 SA071114 SA071115 SA071116 SA071117 SA071118 SA071119 SA071120 SA071121 SA071122 SA071123 SA071124 SA071125
Z-0001-2008 N/A 2007/010/029/061/009 2007/010/025/061/006 2007/010/003/291/012 2007/010/023/601/003 38444 38432 38628 38476 38529 34805 38601 38546
Class II Firm Initiated Field Action FSCA FSCA FSCA FSCA Type II Type II Type II Type II Type II Type II Type II Type II
2007/11/08 2007/11/08 2007/11/09 2007/11/09 2007/11/09 2007/11/09 2007/11/12 2007/11/12 2007/11/12 2007/11/12 2007/11/12 2007/11/12 2007/11/12 2007/11/12
Schmidt BioMed Tech (HK) Ltd N/A Roche Diagnostics (Hong Kong) Limited GE Medical Systems Hong Kong Ltd. N/A N/A Terumo China (H.K.) Ltd. Sanko Medical System (HK) Ltd Baxter Healthcare Ltd Abbott Laboratories Ltd. Abbott Laboratories Ltd. Siemens Ltd. Siemens Ltd. Beckman Coulter Hong Kong Ltd.
2620 8320 N/A 2485 7510 2783 1838 N/A N/A 2866 0811 2384 0688 2807 8517 2806 4021 2806 4021 2810 7533 2810 7533 2240 6260
Medical Device Control Office
85
Department of Health The Government of HKSAR
SA071126 SA071127 SA071128 SA071129 SA071130 SA071131 SA071132 SA071133 SA071134 SA071135 SA071136 SA071137 SA071138 SA071139 SA071140 SA071141 SA071142 SA071143 SA071144 SA071145 SA071146 SA071147 SA071148 SA071149 SA071150 SA071151 SA071152 SA071153 SA071154
Remel Wellcogen N Meningitidis B/E Coli K Respironics Various Devices and Accessories Medtronic Sofamor Danek METRx System Bayonet Electrosurgical Pencil (REF (P/N) 9560575) Philips Brilliance CT Big Bore (Model No. 728243) GE Voluson E8 ultrasound scanner (version 6.2.0 and 6.2.1) Siemens Medical charge-particle radiation therapy system (Mevatron, Oncor and Primus) GE Signa MFO/I Magnetic Resonance System GE Sunisa Flexi-DT S0014115 Digital Table Flexi-DT Abbott AxSYM Digoxin III Reagent Pack (List 6L07-20) Smiths Medical Portex Perfit Percutaneous Tracheostomy Tube Replacement Kit (Sterile Ref: 536090) Encore Medical Foundation Hip System Bipolar Modular Cardinal Health Texium Closed Male Luer (CML) (Model No.: 10012241) Varian Ximatron Digital Imaging (Ximavision) Karl Storz Fluid Management Stand (Product No. 26601EQ-KT) B Braun FT420T and FT430T CASPAR APC Medical Bedside Temporary Cardiac Pacemaker (Model 4170) P3 Medical Robertshaw Endobronchial tubes (Rubber, Disposable) Respironics Esprit Ventilator Olympus KeyMed BML-V232QR-26, BML-V232QR-30, BMLV242QR-30 and BML201Q Pride Mobility Quantum 6000, 6000Z, 600, R-4000 and 1420, Pride LX Power wheelchair DiaSorin LIAISON Toxo IgM (Cat no 310710, lot no: 035052, 035052/1, 035052/2) Boston Scientific LeVeen SuperSlim Needle Electrodes Boston Scientific Impulse Angiographic Catheter Ethicon Endopath 5mm Curved Dissector with Monopolar Cautery (Product Code: 5DCD, Lot no. D4HZ9Y) Invacare Typhoon Power Wheelchairs Bio-Rad Variant II Turbo Hemoglobin Testing System Kavo Estertica E80 Treatment Unit GE AW 4.2, AW Volumeshare and AW Volumeshare 2 BD BBL Fluid Thioglycollate Medium and BBL Trypticase Soy Broth (Model no 299108 and 299107)
Health Canada Health Canada FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA MHRA MHRA MHRA MHRA MHRA MHRA MHRA Boston Scientific(HK) Ltd Boston Scientific(HK) Ltd MHRA MHRA MHRA MHRA Health Canada Health Canada
37147 38678 Z-0114-2008 Z-0121-2008 Z-0113-2008 Z-0155-2008 to Z-0169-2008 Z-0170-2008 Z-0075-2008 Z-0064-2008 Z-0100-2008 Z-0082-2008 to Z-0099-2008 Z-0218-2008 Z-0213-2008 Z-0144-2008 2007/011/066/291/003 2007/006/005/401/014 2007/010/030/601/002 2007/077/077/291/004 2007/009/025/601/002 2007/008/008/301/001 2007/009/027/601/003 N/A N/A 2007/011/014/291/006 2007/004/020/261/001 2007/011/014/061/010 2007/011/013/061/011 38214 38700
Type II Type II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II FSCA FSCA FSCA FSCA FSCA FSCA FSCA Firm Initiated Field Action Firm Initiated Field Action FSCA FSCA FSCA FSCA Type I Type II
2007/11/12 2007/11/12 2007/11/19 2007/11/19 2007/11/19 2007/11/19 2007/11/19 2007/11/19 2007/11/19 2007/11/19 2007/11/19 2007/11/19 2007/11/19 2007/11/19 2007/11/20 2007/11/20 2007/11/20 2007/11/20 2007/11/22 2007/11/22 2007/11/22 2007/11/26 2007/11/26 2007/11/26 2007/11/26 2007/11/26 2007/11/26 2007/11/27 2007/11/27
Wenline Company Celki Medical Company Medtronic International, Ltd. Philips Electronics Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. Siemens Ltd. GE Medical Systems Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. Abbott Laboratories Ltd. Smiths Medical (S.E. Asia) Ltd. N/A N/A Varian Medical Systems Pacific Inc. Karl Storz Endoscopy China Ltd B. Braun Medical (HK) Ltd N/A N/A Celki Medical Company Olympus Hong Kong Ltd N/A N/A Boston Scientific (HK) Ltd Boston Scientific (HK) Ltd Johnson & Johnson Medical Hong Kong N/A Bio-Rad Pacific Ltd. N/A GE Medical Systems Hong Kong Ltd. BD
2521 2439 2332 3366 2919 1362 2876 7525 2783 1838 2810 7533 2783 1838 2783 1838 2806 4021 2648 7700 N/A N/A 2724 2836 2865 2411 2277 6611 N/A N/A 2268 9258 2376 1805 N/A N/A 2960 7128 2960 7128 2738 2818 N/A 2789 3300 N/A 2783 1838 2575 8668
Medical Device Control Office
86
Department of Health The Government of HKSAR
SA071155 SA071156 SA071157 SA071158 SA071159 SA071160 SA071161 SA071162
GE Definium 8000 Table and Revolution XR/d Table Abbott i-STAT Cartridges Philips Intellivue Patient Monitor System - Multi Measurement Server (Model no. M3001A) Medline Septoplasty Pack (Lot # 07CD1090 and 07DD3113) Zimmer Trilogy Cluster Hole Shell, Non Coated (Model 620006022, lot 26208600) Bard Atlas PTA Balloon Dilation Catheter (Model AT-120124, Lot GFRF1789) Patterson Dental Mirror Defogger / Solution (Lot 25622) Hill-Rom Versacare Hospital Beds (model P3200 and P3201) GE OEC Insta Trak 3500 Plus with the Cranial Application GE OEC Insta Trak 3500 Plus Fluoro Trak and Fluoro CAT Spinal Applications Stryker wheeled stretcher (various models) Stryker T2 Locking Screw (Cat no 1896-5070S) Clarisonic Skin care system Coloplast Elefant Suction- Irriagtion Device ASP1 Abbott Clinical Chemistry Aeroset/Architect (c Systems) Bilirubin Calibrator (List no 1E66-03 & 1E66-04) B. Braun Vena Tech LP Vena Cava Filter System (Item no/REF 05010024, Model no 40DLP) Biomet Interlok 67mm Fixed Cruciate Tibial Plate with Locking Bar; CO-CR-MO/TI 6AL 4V Alloy (Product ref 141232) Baxter Duploject Easy Prep, Fibrin Sealant Preparation and Application System ISO (Product codes: 1500949 - 1500952) Metrika A1CNOW+ Sampler 10-Test Kits (Product no.: 3022) Boston Scientific PATHWAY Balloon Expandable Ureteral Access Sheath CME Mckinley MicroSet NDEHP with 1.2 filter and SR segment (CME Code: 120-112SFV) (Lot no. 3399-7, 3400-7, 3401-7, 34027, 3403-7, 3404-7, 3405-7) Smith & Nephew Femoral and Tibial Components of TC Plus, VKS and RT Plus Knee Implants
Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada FDA FDA FDA FDA FDA FDA MHRA FDA FDA FDA FDA FDA Boston Scientific(HK) Ltd MHRA MHRA
36689 38822 32105 38314 38744 38941 38884 38502 Z-0240-2008 Z-0183-2007 Z-0181-2007 Z-0219-2008 to Z-0239-2008 Z-0214-2008 Z-0182-2008 2007/011/013/061/021 Z-0288-2008 Z-0264-2008 Z-0255-2008 Z-0263-2008 Z-0289-2008 N/A 2007/008/009/061/014 2007/011/029/291/001
Type II Type II Type II Type II Type II Type II Type I Type II Class II Class II Class II Class II Class II Class II FSCA Class II Class II Class II Class II Class II Firm Initiated Field Action FSCA FSCA
2007/11/27 2007/11/27 2007/11/27 2007/11/27 2007/11/27 2007/11/27 2007/11/27 2007/11/27 2007/11/27 2007/11/27 2007/11/27 2007/11/27 2007/11/27 2007/11/28 2007/11/29 2007/11/29 2007/11/29 2007/11/29 2007/11/29 2007/11/30 2007/11/30 2007/11/30
GE Medical Systems Hong Kong Ltd. Abbott Laboratories Ltd. Philips Electronics Hong Kong Ltd. N/A Zimmer PTE Ltd. (Hong Kong branch) N/A N/A N/A GE Medical Systems Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. Stryker China Ltd Stryker China Ltd N/A Coloplast (Hong Kong) Ltd Abbott Laboratories Ltd. B. Braun Medical (Hong Kong) Ltd. Goodman Medical Supplies Ltd Baxter Healthcare Ltd N/A Boston Scientific (HK) Ltd N/A Smith & Nephew Ltd.
2783 1838 2806 4021 2876 7525 N/A 2992 0968 N/A N/A N/A 2783 1838 2783 1838 2518 6988 2518 6988 N/A N/A 2806 4021 2277 6162 2332 4455 2807 8517 N/A 2960 7117 N/A 2648 7700
SA071163 SA071164 SA071165 SA071166 SA071167 SA071168 SA071169 SA071170 SA071171 SA071172 SA071173 SA071174 SA071175 SA071176
Medical Device Control Office
87
Department of Health The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - October 2007
Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. No. SA071001 SA071002 SA071003 SA071004 SA071005 SA071006 SA071007 SA071008 SA071009 SA071010 SA071011 SA071012 SA071013 SA071014 SA071015 SA071016 SA071017 SA071018 SA071019 SA071020 SA071021 SA071022 SA071023 SA071024 SA071025 SA071026 SA071027 SA071028 SA071029 Description of Product Boston Scientific Advanced Bionics Electrode Insertion Tool for HiRes 90KR with HiFocus HelixR Electrode Cardinal Health Procedure Pack CODAN PVB (Product Code STP 85, Lot No. 700265 & 700995) Pride Mobility Power Chairs Varian Acuity radiation therapy simulation systems Baxa Exacta-Mix 2400 OS v 1.07 (Model No. 8300-0073) Pharmacy Compounding System GE Healthcare OEC9900, OEC9800 and OEC8800 Philips Gemini 16, Gemini GXL, Precedence and Brilliance Philips Bucky, Digital and Easy Diagnost X-Ray System & Easy, Omni and Multi Diagnost Eleva Philips Pinnacle3 Radiation Therapy Planning (RTP) System and its associated Software Intuitive brand Da Vinci Surgical System (Model No. IS2000, Part no. 351040-04) Intuitive brand Da Vinci Surgical System Endoscopic Instrument Control System (Model IS1200, A4.3 SW Level) GE Innova 2100-IQ Digital Fluoroscopic Imaging System Cerner Millennium RadNet Auto Launch Study and Auto Launch Report Software functionalilites Davol Salute Fixation Reusable Handle, Fixation Reusable Shaft, Laparoscopic Sterile Implant Cartridge and Short Sterile Implant Cartridge Cardinal Health Pyxis Anesthesia System 3500 (Model 3500) Stryker Trident PSL Acetabular Shell Hitachi Medical Altaire Shoulder Coil DeRoyal Assorted sterile surgical kits/trays NxStage Cartridge Express (CAR-170) Summit LX125 Swivel Collimator (Model D800), LX125V Swivel Collimator (Model E600) and PCS125 Swivel Collimator (Model F100) Merit Medical Surgical Convenience Kits, Custom and SPPT BD Neisseria Meningitidis Antisera Group Y Siemens Biograph Duo LSO, Biograph 6 and Biograph 16 Boots Blood Glucose Monitoring System (50-53-811) GE Flexi-DT Mobile Radiographic Table Otto Bock Standard Kimba Spring (Ref TS8423) Boston Scientific Transend EX Standard 0.014" Guidewire Boston Scientific Advanced Bionics PrecisionR Implantable Pulse Generator -UPNM365SC11100 Source of Information Boston Scientific(HK) Ltd MHRA MHRA MHRA Varian Medical Systems Pacific Inc. FDA MHRA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA Health Canada Health Canada MHRA MHRA MHRA Boston Scientific(HK) Ltd Boston Scientific(HK) Ltd Reference No. by Source N/A 2007/008/024/061/003 2007/009/003/051/002 2005/011/016/301/004 CP-2007-001 Z-1238-2007 2007/008/029/291/017 Z-0013-2007 to Z-0014-2007 Z-0907-2007 to Z-0912-2007 Z-1212-2007 Z-1245-2007 Z-1244-2007 Z-1088-2007 Z-1243-2007 Z-1266-2007 to Z-1273-2007 Z-0555-2007 Z-1261-2007 Z-1263-2007 Z-1205-2007 Z-1228-2007 Z-1216-2007 to Z-1218-2007 Z-1262-2007 37610 37227 2007/008/030/291/007 2006/008/017/601/229 2007/004/010/301/001 N/A N/A Alert Type by Source Firm Initiated Field Action FSCA FSCA FSCA Firm Initiated Field Action Class I FSCA Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Class II Type II Type II FSCA FSCA FSCA Firm Initiated Field Action Firm Initiated Field Action Date of Issue (YYYY/MM/DD) 2007/10/02 2007/10/02 2007/10/02 2007/10/03 2007/10/03 2007/10/04 2007/10/04 2007/10/04 2007/10/04 2007/10/04 2007/10/04 2007/10/04 2007/10/04 2007/10/04 2007/10/04 2007/10/04 2007/10/04 2007/10/04 2007/10/04 2007/10/04 2007/10/04 2007/10/04 2007/10/04 2007/10/04 2007/10/05 2007/10/05 2007/10/08 2007/10/10 2007/10/10 Local Agent Boston Scientific (HK) Ltd N/A N/A N/A Varian Medical Systems Pacific Inc. Jaspo Limited GE Medical Systems Hong Kong Ltd. Philips Electronics Hong Kong Ltd. Philips Electronics Hong Kong Ltd. Philips Electronics Hong Kong Ltd. N/A N/A GE Medical Systems Hong Kong Ltd. N/A N/A N/A Stryker China Ltd N/A N/A N/A N/A N/A BD Siemens Ltd. N/A GE Medical Systems Hong Kong Ltd. Otto Bock Asia Pacific Limited Boston Scientific (HK) Ltd Boston Scientific (HK) Ltd Agent Contact Telephone No 2960 7128 N/A N/A N/A 2724 2836 2713 0007 2783 1838 2876 7525 2876 7525 2876 7525 N/A N/A 2783 1838 N/A N/A N/A 2518 6988 N/A N/A N/A N/A N/A 2575 8668 2810 7533 N/A 2783 1838 2598 9772 2960 7128 2960 7128
Medical Device Control Office
88
Department of Health The Government of HKSAR
SA071030 SA071031 SA071032 SA071033 SA071034 SA071035 SA071036 SA071037 SA071038 SA071039 SA071040 SA071041 SA071042 SA071043 SA071044 SA071045 SA071046 SA071047 SA071048 SA071049 SA071050 SA071051 SA071052 SA071053 SA071054 SA071055 SA071056 SA071057 SA071058 SA071059 SA071060 SA071061 SA071062 SA071063
Varian RTP Exchange software (interface application that supports the electronic transfer of radiation treatment planning data) GE Disposable Multi Absorber Canister CVI OZ Palm Injector (Ref: OZ 1035) Abbott PathFinder Bone Drill-Awl-Tap (Part no. 1156-50 & 1156-60) Meretek BreathTek Urea Hydrolysis Rate Calculation CD, Version 1.3.5-January 1, '03 Invacare REA Wheelchair Pelvic Belt Dale 240 Blue Tracheostomy Tube Holders and Dale 242 Blue Tracheostomy Tube Holders for Neonates to Infants Varian Real-time Position Management System (RPM) version 1.7 MAQUET ELS-Cannulae Stryker Locking Screw, Fully Threaded 5 x 70 mm (Cat. no. 18965070S, Lot/Batch no. K871252) Karl Storz Morcellator Cutter 12mm Siemens Mobile Magnetom Harmony, Symphony and Sonata Systems B Braun Aesculap e.motion and Columbus femoral components Baxter Colleague Triple Channel Mono, CX and CXE Volumetric Infusion Pumps (Product Codes: 2M8153 & 2M9163) Medtronic Sprint Fidelis Defibrillation Leads Toshiba Nemio and Nemio XG Ultrasound systems BD Multiset software version 2.1, 2.1.1 and 2.2 Otto Bock The Back 2, 3 and 4 Respironics DEAS Heated Wire Circuits Masimo Rad 9 Pulse Oximeters BD CellQuest Pro Software v4.0.2, 5.0.1, 5.1, 5.1.1, 5.2 and 5.2.1 Beckman Coulter Access Immunoassay Systems Ultrasensitive Insulin Reagent Kit Park House Healthcare Phase Type 1 Cell (Product code: PHSP116) Zeiss Hydromax (batches 6500 and 6271) SensorCare Systems Control Unit Cyberonics VNS Therapy Software, Model 250 GE Healthcare Disposable Multi Absorber Canister with the EZ change Module movingpeople.net Trophy 6 electrical scooters Pluss GZL080A Wheelchair restraint belt Boston Scientific IMAGERT II Angiographic Cather Siemens Digital Linear Accelerators Siemens C.Cam Imaging System Siemens Mevatron Linear Accelerators Siemens Troponin Ultra (TNI-ULTRA) Assay
Varian Medical Systems Pacific Inc. FDA FDA FDA FDA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA Medtronic International, Ltd. MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA Cyberonics MHRA MHRA MHRA Boston Scientific(HK) Ltd Health Canada Health Canada Health Canada Health Canada
CP-2007-093 Z-0006-2008 Z-0008-2008 Z-0004-2008 to Z-0005-2008 Z-0003-2008 2007/006/025/261/001 2007/009/028/291/005 2007/010/002/061/003 2007/010/003/291/010 2007/009/025/291/002 2007/010/004/061/011 2007/008/029/291/010 2007/009/017/291/009 2007/010/004/291/001 N/A 2007/009/026/061/007 2007/009/027/061/011 2006/010/011/301/002 2007/009/011/291/007 2007/008/014/061/002 2007/009/027/061/010 2007/009/027/601/002 2007/008/013/051/002 2007/009/010/291/009 2006/008/007/401/006 N/A 2007/008/001/601/004 2007/008/014/061/005 2004/012/008/401/008 N/A 37632 37749 37825 37323
Firm Initiated Field Action Class II Class II Class II Class II FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA Firm Initiated Field Action FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA Firm Initiated Field Action FSCA FSCA FSCA Firm Initiated Field Action Type II Type II Type II Type II
2007/10/10 2007/10/11 2007/10/11 2007/10/11 2007/10/11 2007/10/11 2007/10/11 2007/10/12 2007/10/12 2007/10/12 2007/10/12 2007/10/12 2007/10/12 2007/10/15 2007/10/15 2007/10/16 2007/10/16 2007/10/16 2007/10/16 2007/10/16 2007/10/16 2007/10/16 2007/10/17 2007/10/17 2007/10/17 2007/10/17 2007/10/18 2007/10/18 2007/10/18 2007/10/18 2007/10/22 2007/10/22 2007/10/22 2007/10/22
Varian Medical Systems Pacific Inc. GE Medical Systems Hong Kong Ltd. Suburfarm Investment and Trading Co. Ltd. Abbott Laboratories Ltd. N/A N/A N/A Varian Medical Systems Pacific Inc. Maquet Hong Kong Limited Stryker China Ltd N/A Siemens Ltd. N/A Baxter Healthcare Ltd Medtronic International, Ltd. Sanko Medical System (HK) Ltd BD Otto Bock Asia Pacific Limited N/A N/A BD Beckman Coulter Hong Kong Ltd. N/A N/A N/A N/A GE Medical Systems Hong Kong Ltd. N/A N/A Boston Scientific (HK) Ltd Siemens Ltd. Siemens Ltd. Siemens Ltd. Siemens Ltd.
2724 2836 2783 1838 2780 9421 2806 4021 N/A N/A N/A 2724 2836 2393 9511 2518 6988 N/A 2810 7533 N/A 2807 8555 2919 1362 2384 0688 2575 8668 2598 9772 N/A N/A 2575 8668 2240 6260 N/A N/A N/A N/A 2783 1838 N/A N/A 2960 7128 2810 7533 2810 7533 2810 7533 2810 7533
Medical Device Control Office
89
Department of Health The Government of HKSAR
SA071064 SA071065 SA071066 SA071067 SA071068 SA071069 SA071070 SA071071 SA071072 SA071073 SA071074 SA071075 SA071076 SA071077 SA071078 SA071079
Baxter Amiscus Separator Medtronic TSRH Silo Spinal System- Sagittal Adjusting Screw for Rod - TI Radiometer Pump waste tube for blood gas analysis kit Diagnostica STA Compact and STA Compact CT Mallinckrodt Angiomat Illumena Injector with Auxiliary Console I-Flow ON-Q PainBuster with OnDemand (Model PMB01) Pml Microbiologicals Brain Heart Infusion Agar labeled BHIA + Vancomycin 6MCG/ML for screening for Vancomycin Resistant Enterococc (Cat# P1174) Pml Microbiologicals Brain Heart Infusion Agar labeled BHIA + Vancomycin 6MCG/ML Microbiological media plates (Cat# P1174) Medtronic Model Model 7428 Kinetra and Model 7426 Soletra implantable neurostimulators Abbott ARCHITECT cSystems Medtronic Nexframe Stereotactic System Gelita Medical Gelitacel Oxidized Cellulose Haemostat Gauze BD Microtainer Safety Flow Lancets (Cat. No. 366356, 365759, 366357) Days Healthcare Transportable Wheelchairs Siemens Clinitest hCG Cassette Smiths Medical EMS Ventilator circuits (Product code W196-002)
Health Canada Health Canada FDA FDA FDA FDA FDA FDA Medtronic International, Ltd. MHRA MHRA MHRA FDA MHRA MHRA MHRA
37954 37878 Z-0038-2008 Z-0039-2008 Z-0056-2008 Z-0057-2008 Z-0014-2008 Z-0011-2008 N/A 2007/009/014/601/003 2007/010/011/061/005 2007/010/015/291/003 Z-0044-2008 to Z-0046-2008 2007/005/018/401/005 2007/010/018/061/010 MDA/2007/080
Type II Type II Class II Class II Class II Class II Class II Class II Firm Initiated Field Action FSCA FSCA FSCA Class II FSCA FSCA MDA
2007/10/22 2007/10/22 2007/10/22 2007/10/22 2007/10/22 2007/10/22 2007/10/22 2007/10/22 2007/10/22 2007/10/23 2007/10/23 2007/10/23 2007/10/25 2007/10/25 2007/10/25 2007/10/25
Baxter Healthcare Ltd Medtronic International, Ltd. N/A N/A Tyco Healthcare (HKSAR) Limited N/A N/A N/A Medtronic International, Ltd. Abbott Laboratories Ltd. Medtronic International, Ltd. N/A BD N/A Siemens Ltd. Smiths Medical (S.E. Asia) Ltd.
2807 8555 2919 1362 N/A N/A 3157 7244 N/A N/A N/A 2919 1362 2806 4021 2919 1362 N/A 2575 8668 N/A 2810 7533 N/A
Medical Device Control Office
90
Department of Health The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - September 2007
Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. No. SA070901 Description of Product Boston Scientific Radial Jaw 4 Large Capacity Foreceps Source of Information Boston Scientific(HK) Ltd MHRA JianXi FDA Varian Medical Systems Pacific Inc. Health Canada Health Canada FDA Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Boston Scientific(HK) Ltd Boston Scientific(HK) Ltd FDA FDA FDA FDA FDA Reference No. by Source N/A 2007-008-024-061-012 N/A N/A 37021 36862 N/A 30529 29940 36601 36799 35983 34788 36419 36844 36800 N/A N/A Z-0777-2007 Z-1219-2007 Z-1198-2007 to Z-1200-2007 Z-1201-2007 Z-1202-2007 Alert Type by Source Firm Initiated Field Action FSCA N/A Firm Initiated Field Action Type II Type II Press Release Type II Type II Type II Type II Type II Type II Type II Type II Type II Firm Initiated Field Action Firm Initiated Field Action Class II Class II Class II Class II Class II Date of Issue (YYYY/MM/DD) 2007/09/03 2007/09/05 2007/09/06 2007/09/11 2007/09/11 2007/09/11 2007/09/11 2007/09/14 2007/09/14 2007/09/14 2007/09/14 2007/09/14 2007/09/14 2007/09/14 2007/09/14 2007/09/14 2007/09/14 2007/09/14 2007/09/14 2007/09/14 2007/09/14 2007/09/14 2007/09/14 Local Agent Boston Scientific (HK) Ltd Smiths Medical (S.E. Asia) Ltd. Jindun International (HK) Ltd Varian Medical Systems Pacific Inc. BD BD Abbott Laboratories Ltd. Smiths Medical (S.E. Asia) Ltd. Smiths Medical (S.E. Asia) Ltd. Terumo China (H.K.) Ltd. Siemens Ltd. N/A Gambro China Ltd. N/A N/A N/A Boston Scientific (HK) Ltd Boston Scientific (HK) Ltd BD N/A Abbott Laboratories Ltd. N/A Abbott Laboratories Ltd. Agent Contact Telephone No 2960 7128 N/A 2851 0879 2724 2836 2575 8668 2575 8668 2806 4021 N/A N/A 2866 0811 2810 7533 N/A 2839 7010 N/A N/A N/A 2960 7128 2960 7128 2575 8668 N/A 2806 4021 N/A 2806 4021
SA070902 Smith & Nephew Full radius, 4.5 mm Concave Disposable Blade (Item Code 7205335) SA070903 Jiangxi Sanxin / "Yixin" Disposable Intravenous Administration Set SA070904 Varian clinacs
SA070905 BD Epicentre Microbiology Data Management SA070906 BD FA Stretococcus Group A
SA070907 Abbott Blood Glucose Meter: Precision Xtra, Optium, ReliOn Ultima, Rite Aid and Kroger SA070908 SA070909 SA070910 SA070911 Smiths Medical Hyperflex (Model 75 FHXL80) Smiths Medical Epidural Minipack and Epidural Syringe Terumo Advanced Perfusion System 1 Base and Roller Pumps Siemens Siregraph CF
SA070912 Randox Laboratories Carbon Dioxide Reagent SA070913 SA070914 Gambro Prisma Continuous Fluid Management System Focus Surgery Sonablate 500
SA070915 Conmed Linvatec Ultrapower Burr and Ultrapower Burr Diamond SA070916 PreMD PREVU Point of Care Skin Sterol Test SA070917 SA070918 Boston Scientific Mach 1 Guide Catheter Boston Scientific Renegade HiFlo Microcatheter Kit
SA070919 BD Vacutainer Safety-Lok Blood Collection Set with Preattached Holder (Catalog #368652) SA070920 Molnlycke Biogel Skinsense Polyisoprene Surgical Gloves, NonLatex, Sterile (Size 8) SA070921 Abbott CELL-DYN 3000, CELL-DYN 3500 and CELL-DYN 3700 Hematology Analyzer SA070922 Sendx Medical (Radiometer Capenhagen ) ABL8O FLEX Software Version 1.10 (Model no. 914863) SA070923 Abbott AxSYM System Digoxin III Reagent Pack
Medical Device Control Office
91
Department of Health The Government of HKSAR
SA070924
Abbott Multi-Link Vision RX Coronary Stent System
FDA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA FDA MHRA MHRA MHRA MHRA MHRA MHRA FDA Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada
Z-1211-2007 2007/008/022/601/001 2007/008/028/061/007 2007/007/005/401/001 2007/008/009/061/006 2007/008/016/401/005 2006/009/019/301/001 2007/001/023/081/009 2006/010/011/261/001 2007/006/005/061/010 2007/008/014/601/004 2007/007/025/061/016 N/A 2007/007/030/061/008 2007/004/017/131/017 2007/008/024/291/005 MDA/2007/071 MDA/2007/070 MDA/2007/073 37014 37211 37035 35873 31983 36691 37173 37033
Class II FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA Press Release FSCA FSCA FSCA MDA MDA MDA Class I Type II Type II Type II Type II Type II Type II Type II
2007/09/14 2007/09/17 2007/09/17 2007/09/17 2007/09/17 2007/09/17 2007/09/17 2007/09/17 2007/09/17 2007/09/17 2007/09/17 2007/09/17 2007/09/18 2007/09/18 2007/09/18 2007/09/18 2007/09/18 2007/09/18 2007/09/18 2007/09/19 2007/09/19 2007/09/19 2007/09/19 2007/09/19 2007/09/19 2007/09/19 2007/09/19
Abbott Laboratories Ltd. N/A N/A N/A N/A Uninet Technology Ltd N/A Philips Electronics Hong Kong Ltd. N/A Abbott Laboratories Ltd. Abbott Laboratories Ltd. Johnson & Johnson Medical Hong Kong B. Braun Medical (Hong Kong) Ltd. N/A Roche Diagnostics (Hong Kong) Limited Smiths & Nephew Healthcare (Hong Kong) BD N/A N/A N/A Abbott Laboratories Ltd. Abbott Laboratories Ltd. Abbott Laboratories Ltd. Abbott Laboratories Ltd. Medtronic International, Ltd. Medtronic International, Ltd. Siemens Ltd.
2806 4021 N/A N/A N/A N/A 2838 8423 N/A 2876 7525 N/A 2806 4021 2806 4021 2738 2818 2277 6162 N/A 2485 7510 2648 7700 2575 8668 N/A N/A N/A 2806 4021 2806 4021 2806 4021 2806 4021 2919 1362 2919 1362 2810 7533
SA070925 Dade Behring Dimension clinical chemistry system Total Bilirubin (TBIL) Flex reagent cartridge (Cat# DF67A) (Lot: FC8170) SA070926 Biomet Austin-Moore and Thompson Endoprotheses SA070927 Roma Medical Bed Support Handle Model 5423
SA070928 Elekta Synergy Linear accelerator XVI SA070929 Immucor Galileo SA070930 Chas A. Blatchford & Sons Ltd Derby Seat / Moulded Seat Insert SA070931 Philips MR Systems SA070932 Cascade Designs Varilite Back Support
SA070933 Abbott Precision Plus Blood Glucose Electrodes / Test Strips (Lot no. 96425) SA070934 Abbott Bilirubin Calibrator : 1E66-04 SA070935 SA070936 SA070937 SA070938 SA070939 SA070940 Depuy Engage Modular Revision Hip Implant Component B. Bruan Medical Normal Saline Flush Syringes (Lot no "SFR") Stericom STE 4021 Proctoscope Roche Online TDM Tobramycin for Modular Analytics {P} System Smith & Nephew CALAXO Interference Screw BD Plastipak 1ml, 2ml, 5ml and 10ml hypodermic Luer slip syringes
SA070941 Universal Hospital Supplies Sterile suction connecting tubing (ref no. UN30026FFM) SA070942 Eschmann Electrosurgery bipolar unit (model TDB 60) SA070943 SA070944 SA070945 SA070946 Welch Allyn AED20 Automatic External Defibrillators Abbott Muligent Acetaminophen Assay Abbott Commander System Analyzer Class 4 Abbott Architect System - Lipase Assay
SA070947 Abbott Freestyle Freedom Blood Glucose Monitorinf System, Freestyle Blood Glucose Monitoring System, Freestyle Mini Blood Glucose Monitoring System SA070948 Medtronic Export XT Catheter SA070949 Medtronic Paceart System Software - 2006 1st Edition
SA070950 Siemens Biograph 2, Biograph 6 and Biograph 16
Medical Device Control Office
92
Department of Health The Government of HKSAR
SA070951
Smiths Medical Portex Perfit Percutaneous Dilational
Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada MHRA MHRA FDA Boston Scientific(HK) Ltd MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA FDA FDA FDA FDA FDA FDA
28486 30639 24935 37262 36919 37229 35889 37147 37057 MDA/2007/074 MDA/2007/075 Z-1234-2007 N/A 2007/009/010/291/012 2007/008/003/601/006 2007/008/010/061/010 2007/007/030/051/009 2007/009/010/291/015 2007/008/028/061/009 2007/006/014/601/002 2007/007/024/061/008 Z-1239-2007 Z-1009-2007 Z-1221-2007 Z-1224-2007 Z-1222-2007 Z-1226-2007
Type II Type II Type II Type II Type II Type II Type II Type II Type II MDA MDA Class II Firm Initiated Field Action FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA Class II Class II Class II Class I Class II Class II
2007/09/19 2007/09/19 2007/09/19 2007/09/19 2007/09/19 2007/09/19 2007/09/19 2007/09/19 2007/09/19 2007/09/19 2007/09/19 2007/09/20 2007/09/21 2007/09/21 2007/09/21 2007/09/21 2007/09/21 2007/09/21 2007/09/24 2007/09/24 2007/09/24 2007/09/27 2007/09/27 2007/09/27 2007/09/27 2007/09/27 2007/09/27
Smiths Medical (S.E. Asia) Ltd. Smiths Medical (S.E. Asia) Ltd. Smiths Medical (S.E. Asia) Ltd. Siemens Ltd. Draeger Medical Hong Kong Ltd. Draeger Medical Hong Kong Ltd. Agfa Hong Kong Limited N/A N/A N/A N/A Philips Electronics Hong Kong Ltd. Boston Scientific (HK) Ltd N/A N/A GM Medical (Hong Kong) Ltd Roche Diagnostics (Hong Kong) Limited Medtronic International, Ltd. N/A Arjo Far East Ltd (Hong Kong) Smiths Medical (S.E. Asia) Ltd. Stryker China Ltd Stryker China Ltd N/A N/A Abbott Laboratories Ltd. BD
2648 7700 2648 7700 2648 7700 2810 7533 2877 3077 2877 3077 2555 9421 N/A N/A N/A N/A 2876 7525 2960 7128 N/A N/A 2783 1838 2485 7510 2919 1362 N/A 2508 9553 2648 7700 2518 6988 2518 6988 N/A N/A 2806 4021 2575 8668
SA070952 Smiths Medical Portex Epidural and Spinal Needle Set SA070953 Smiths Medical Graseby MS26 Syringe Driver
SA070954 Siemens Lithoskop SA070955 Draeger Medical Babylog 8000 SA070956 Draeger Medical D-Vapor
SA070957 Agfa Healthcare Impax DS3000 Diagnostic Pacs, Impax ES (5.0) for Cardiology, Impax for Cardiology, MA3000 Mammographic Workstation, Impax OT3000 Orthopaedic Workstation, Web 1000 SA070958 Remel Wellcogen Bacterial Antigen Test SA070959 Ivoclar Vivadent Odyssey Diode Laser SA070960 Invacare Action 2000 wheelchairs (blue frame) SA070961 Invacare Action 3 wheelchairs
SA070962 Philips Isolation Transformer SA070963 Boston Scientific Advanced Bionics Patient Controller SC-5400 (Joystick Controller) SA070964 Bard Guidewire 70 cm x 1 mm (0.038") (Product Code: 5583705) SA070965 Vertec, Hologic Fluoroscan Premier and Encore Image Intensifiers SA070966 Cyberonics VNS Therapy Leads SA070967 Roche LightCycler 2.0 Instrument Software v 4.05.415 Deficiency and LightCycler SeptiFast Test M SA070968 Medtronic Spinal Implants: Colorado II Locking Nut#8634111 SA070969 Metrax Primedic - DefiMonitor Models DX1, XD3, XD10, XD30, XD100, XD300, XD110, XD330 SA070970 Arjo Otter lift and Arjo Pool Lift SA070971 Smiths CADD Medication Cassette Reservoir SA070972 Stryker Radius Lcoking Caps (Cat. No. 486610000) SA070973 Stryker Wheeled Electric Stretcher Model 1550 SA070974 Biomet 3i LTX XP Miniplant, Dental Implant, Sterile (Model No LTX3211 and Model LTX3213) SA070975 Baxter Colleague CX Single Channel Volumetric Infusion Pumps, product code 2M8161 SA070976 Abbott ARCHITECT Prolactin MasterCheck SA070977 BD ReliOn 0.5cc 3g x 8mm Bilster Pak U-100 Syringe
Medical Device Control Office
93
Department of Health The Government of HKSAR
SA070978
Kimberly Clark BALLARD BAL CATH Kit
Kimberly Clark Health Care FDA FDA FDA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA
N/A Z-1227-2007 Z-1225-2007 Z-1192-2007 2007/009/012/291/004 2006/010/012/301/001 2007/007/030/051/005 2007/003/008/081/010 2007/009/012/061/006 2006/010/012/301/004 2007/009/019/061/002 2007/009/017/291/010
Firm Initiated Field Action Class II Class II Class II FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA
2007/09/27 2007/09/27 2007/09/27 2007/09/27 2007/09/27 2007/09/27 2007/09/28 2007/09/28 2007/09/28 2007/09/28 2007/09/28 2007/09/28
N/A Medtronic International, Ltd. N/A N/A N/A N/A N/A N/A Varian Medical Systems Pacific Inc. N/A Gambro China Ltd. N/A
N/A 2919 1362 N/A N/A N/A N/A N/A N/A 2724 2836 N/A 2576 2688 N/A
SA070979 Medtronic Intersept 3608 Sterile tubing (Lot 7626621) SA070980 Nicolet Biomedical BMSI " MicroJack" PN672-510000 SA070981 Newport HT50 Ventilator (all Models) SA070982 Sorin SR Single Chamber Pacemakers SA070983 G & S Smirthwaite SAMBA Supportive Seating System SA070984 Roma Medical Aids Bed Grab Handle (Model 5425) SA070985 Pegasus Euro Adaptor (Part No. MSM14337) SA070986 Varian Clinacs with Type 3 accessories SA070987 R82 Vests and Belts SA070988 Gambro Spectra Optia System SA070989 B BRAUN Excia Hip Endoprosthesis, cementless, NC410T (LOT 51283009)
Medical Device Control Office
94
Department of Health The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - August 2007
Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. No. SA070801 Description of Product BCI Autocorr Plus patient monitor Source of Information Goodwin Healthcare Ltd. MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA FDA FDA FDA FDA FDA MHRA MHRA MHRA MHRA MHRA MHRA FDA FDA Health Canada Reference No. by Source N/A 2007/006/012/291/002 2007/007/023/061/018 2007/007/025/061/013 2007/007/019/601/002 2007/007/027/291/008, 2007/007/027/291/007 2007/007/012/051/003 2007/007/019/291/018 2007/006/012/401/015 2007/005/023/601/001 2007/007/009/061/003 Z-1110-2007 Z-1096-2007 to Z-1098-2007 Z-1100-2007 to Z-1101-2007 Z-1080-2007 to Z-1085-2007 Z-1057-2007 to Z-1062-2007 2007/007/018/061/005 2006/010/011/301/001 2007/007/024/291/007 2007/007/030/061/008 2007/007/025/291/008 2007/008/002/061/011 Z-1020-2007 Z-1078-2007 32026 Alert Type by Source Firm Initiated Field Action FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA Class II Class II Class II Class II Class II FSCA FSCA FSCA FSCA FSCA FSCA Class II Class II Type II Date of Issue (YYYY/MM/DD) 2007/08/02 2007/08/06 2007/08/06 2007/08/06 2007/08/06 2007/08/06 2007/08/06 2007/08/06 2007/08/06 2007/08/06 2007/08/06 2007/08/06 2007/08/06 2007/08/06 2007/08/06 2007/08/06 2007/08/06 2007/08/07 2007/08/07 2007/08/07 2007/08/07 2007/08/08 2007/08/09 2007/08/09 2007/08/09 Local Agent Goodwin Healthcare Ltd. N/A Philips Electronics Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. Tyco Healthcare (HKSAR) Limited Fresenius Medical Care Asia Pacific Ltd. N/A Abbott Laboratories Ltd. N/A Medtronic International, Ltd. Abbott Laboratories Ltd. N/A N/A N/A Gambro China Ltd. N/A Philips Electronics Hong Kong Ltd. N/A Medtronic International, Ltd. Beckman Coulter Hong Kong Ltd. Vita Company Limited Vita Company Limited Zimmer PTE Ltd. (Hong Kong branch) Agent Contact Telephone No 2408 8838 N/A 2876 7525 2783 1838 2783 1838 2783 1838 3157 7244 2802 2900 N/A 2806 4021 N/A 2919 1362 2806 4021 N/A N/A N/A 2839 7010 N/A 2876 7525 N/A 2919 1362 N/A N/A N/A 2992 0968
SA070802 Cousin Biotech Intrmesh TI - FBIOT12020, FBIOT12025, FBIOT13030, FBIOT13050 SA070803 Philips X-Ray System BV Pulsera and Endura rel.2 with Remote Control SA070804 GE Healthcare OEC InstaTrak 3500 Plus System SA070805 GE Healthcare CardioLab/Mac-Lab IT/ComboLab IT Electrophysiology and Haemodynamic Systems SA070806 GE Healthcare Extended Range Transmitter (Catalog Part 1004070 , 1003991) SA070807 Tyco Kendall Curity Suprapubic Catheter Sets SA070808 Fresenius Medical Care HD Catheters SA070809 SA070810 SA070811 SA070812 Teleflex Medical Hudson RCI Large Volume Nebuliser Abbott ACCELERATOR APS System (7L01-01) Trinity Biotech Captia Measles IgM ELISA Test Kit Medtronic Intersept Filtered Cardiotomy Reservior (Model 1351)
SA070813 Abbott Architect AUSAB Assay SA070814 Sunnex Celestial Star MR-16 and Tri-Star Surgical Exam Light MR16 (Lamp Holder) SA070815 Allez Medical Applications 4Closure Surgical Fascia Closure System SA070816 Gebauer Pain Ease Mist Spray SA070817 Gambro Prismaflex Hemodialysis Unit SA070818 Performance Health Products AXXIS, Comfort and V-Trak
SA070819 Philips Brilliance 40/64 CT Scanners SA070820 Pelican Proctoscope (Product Code 400340) SA070821 Medtronic SynchroMed EL Pump SA070822 Beckman Coulter Cytomics FC 500 Flow Cytometer with CXP Software SA070823 Cardinal Health Alaris IV Administration Infusion Sets SA070824 Cardinal Health Alaris IV Administration Infusion Sets, Low Sorbing Extension Set SA070825 Zimmer M/DN Intramedullary Fixation System
Medical Device Control Office
95
Department of Health The Government of HKSAR
SA070826 SA070827
Cook Fixed Core Stainless Stell Wireguide Cook Black Silicone Filiform Double Pigtail Stent Set
Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada MHRA MHRA MHRA MHRA MHRA MHRA FDA FDA FDA FDA FDA FDA
35942 36639 36465 36463 36560 36426 34278 36506 35738 36355 34861 36279 34044 36188 2007/005/009/061/011 2007/008/007/051/007 2007/007/027/291/009 MDA/2007/062 2007/008/010/061/012 2007/008/001/291/016 Z-1145-2007 to Z-1147-2007 and Z-1152-2007 to Z-11552007 Z-1151-2007 Z-1149-2007 Z-1156-2007 to Z-1158-2007 Z-1141-2007 Z-1131-2007
Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type I Type I FSCA FSCA FSCA MDA FSCA FSCA Class II Class II Class II Class II Class II Class II
2007/08/09 2007/08/09 2007/08/09 2007/08/09 2007/08/09 2007/08/09 2007/08/09 2007/08/09 2007/08/09 2007/08/09 2007/08/09 2007/08/09 2007/08/09 2007/08/13 2007/08/14 2007/08/15 2007/08/15 2007/08/15 2007/08/16 2007/08/16 2007/08/17 2007/08/17 2007/08/17 2007/08/17 2007/08/17 2007/08/17
Cook Asia Ltd Cook Asia Ltd Boston Scientific (HK) Ltd Siemens Ltd. Siemens Ltd. Siemens Ltd. Stryker China Ltd N/A N/A N/A N/A N/A N/A N/A N/A Draeger Medical Hong Kong Ltd. N/A Draeger Medical Hong Kong Ltd. Philips Electronics Hong Kong Ltd. N/A N/A N/A N/A N/A Abbott Laboratories Ltd. N/A
(1) 2781 0232; (2) 2541 1041 (1) 2781 0232; (2) 2541 1041 2960 7128 2810 7533 2810 7533 2810 7533 2518 6988 N/A N/A N/A N/A N/A N/A N/A N/A 2877 3077 N/A 2877 3077 2876 7525 N/A N/A N/A N/A N/A 2806 4021 N/A
SA070828 Boston Scientific Amplatz, CLS Cure, Internal Mamnary, Kimmy, Multipurposse and Voda Guide Catheters SA070829 Siemens ECAT SA070830 Siemens Sonoline Antares and Acusion Antares Premium Edition
SA070831 Siemens Biograph 6 and Biograph 16 SA070832 Stryker Peek Electrosurgical Handle SA070833 Radiometer D711 Reference Membrane ABL7XX
SA070834 Getinge Castle Steam Sterilizers SA070835 SA070836 SA070837 SA070838 Sensor Health Products Cary Blair Enteric Pathogen Transport Cybernius Nephroncare Software 5.1 Full and 5.1A5 Focus Diagnostics HerpeSelect 1 and 2 Immunoblot IgG Kit BHM Medical Nautica Patient Lift
SA070839 Georg Kramer GES.M.B.H. & Co. KG - Atlantis Patient Lift Model 9500 SA070840 Specialised Orthotic Services Stroller buggies SA070841 Draeger Medical Anaesthesia Machine with additional monitor (device combination) SA070842 Cardinal Health Propofol-Schnider Upgrade Kit
SA070843 Draeger Medical Falcon single-use paediatric Miller blades size 00, 0&1 SA070844 Philips X-Ray System Allura Xper FD20/10 Rel. 1.2., FD20 Rel.2.2. SA070845 SA070846 NMPE ISOLOC Software Versions 4.2, 6.0 and 6.5 SA070847 SA070848 Biomet Straight Magnum Inserter Handle ACT VS-1000 Senator Prosthetic Foot Finsbury Orthopaedics ADEPT Acetabular Cups
SA070849 Accellent Precision Bipolar Device ClearGlide EVH Small SA070850 Abbott Embrace Enteral Pump
SA070851 Possis AngioJet XVG Thrombectomy Sets
Medical Device Control Office
96
Department of Health The Government of HKSAR
SA070852
COOK PTFE Wire Guide with 3 cm flexible tip
FDA MHRA MHRA MHRA Boston Scientific(HK) Ltd FDA FDA FDA FDA FDA FDA MHRA MHRA MHRA MHRA MHRA Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada FDA
Z-1162-2007 2007/008/013/061/003 2007/004/003/291/010 2007/008/010/061/004 N/A Z-1170-2007 to Z-1171-2007 Z-1165-2007 Z-1173-2007 Z-1132-2007 to Z-1134-2007 Z-1172-2007 Z-1175-2007 to Z-1177-2007 MDA/2007/065 2007/008/020/051/005 MDA/2007/066 2007/007/016/061/005 2007/008/014/061/008 36667 33984 33985 33982 33981 36673 36696 36531 36629 33951 28852 Z-1193-2007
Class II FSCA FSCA FSCA Firm Initiated Field Action Class II Class II Class II Class II Class II Class II MDA FSCA MDA FSCA FSCA Type I Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Class II
2007/08/17 2007/08/20 2007/08/20 2007/08/20 2007/08/22 2007/08/23 2007/08/23 2007/08/23 2007/08/23 2007/08/23 2007/08/23 2007/08/23 2007/08/23 2007/08/23 2007/08/27 2007/08/27 2007/08/28 2007/08/28 2007/08/28 2007/08/28 2007/08/28 2007/08/28 2007/08/28 2007/08/28 2007/08/28 2007/08/28 2007/08/28 2007/08/30
Cook Asia Ltd Philips Electronics Hong Kong Ltd. N/A Maquet Hong Kong Limited Boston Scientific (HK) Ltd Abbott Laboratories Ltd. Johnson & Johnson Medical Hong Kong
(1) 2781 0232; (2) 2541 1041 2876 7525 N/A 2393 9511 2960 7128 2806 4021 2738 2818
SA070853 Philips Medical System Information Centre SA070854 SA070855 SA070856 SA070857 SA070858 ThermoFisher Scientific Infinity Ammonia Liquid Stable Reagent MAQUET Vessel Cannulae Product Code GK03 and S 1184 Boston Scientific Precision Spare Suture Sleeve Abbott CELL-DYN 1700 Hematology Analyzer Lifescan One Touch SureSoft Lancing Device
SA070859 Sendx Medical ABL77 Cal Pack, Model No. 944-069 SA070860 GE Medical System Mac-Lab System, CardioLab System, ComboLab System SA070861 Sisus- Bath Helper / Sisus All In One SA070862 Louisville ApI Diagnostics APhL HRP IgG & IgM ELISA Kit, APhL HRP IgG ELISA Kit and APhL HRP IgM ELISA Kit SA070863 Hill-Rom TotalCare Duo 2 SA070864 Femcare Nikomed Unimax Disposable Shielded Trocar and Cannula SA070865 North Eos single-use Cusco screw type vaginal specula SA070866 Depuy SmartSeal Pressurisers SA070867 Biomet Optigun 4195 SA070868 Gambro AK-95
GE Medical Systems Hong Kong Ltd. N/A N/A N/A N/A N/A Johnson & Johnson Medical Hong Kong N/A Gambro China Ltd. Terumo China (H.K.) Ltd. Terumo China (H.K.) Ltd. Terumo China (H.K.) Ltd. Terumo China (H.K.) Ltd. Terumo China (H.K.) Ltd. Terumo China (H.K.) Ltd. Biomerieux (Hong Kong) Care Stream Health BD BD Swedish Trading Co., Ltd
2783 1838 N/A N/A N/A N/A N/A 2798 6080 N/A 2839 7010 2866 0811 2866 0811 2866 0811 2866 0811 2866 0811 2866 0811 2356 7033 2564 9751 2575 8668 2575 8668 N/A
SA070869 Terumo Advanced Perfusion System - Roller Pump and Centrifugual Control Unit SA070870 SA070871 Terumo Advanced Perfusion System - Modules Terumo Advanced Perfusion System 1 and Central Control Monitor
SA070872 Terumo Advanced Perfusion System 1 (Model 801041) SA070873 Terumo Advanced Perfusion System 1 (Model 801040, 801041) SA070874 Terumo Sarns Modular Perfusion System 9000, 8000 and Centrifugal System SA070875 Biomerieux AacT/Alert 3D, BacT/Alert 3D 240, BacT/Alert 3D Combi SA070876 Kodak Direct View DR3000 System 80kW Generator SA070877 BD Procount Progenitor Cell SA070878 BD Difco Shigella Antiserum Poly A1 SA070879 Steris Amsco Century Medium Steam Sterilizer & SFPP Steam Sterilizer
Medical Device Control Office
97
Department of Health The Government of HKSAR
SA070880
Dade Behring EasyLink Informatics System Software version 3.0
FDA FDA
Z-1174-2007 Z-1178-2007 to Z-1181-2007
Class II Class II
2007/08/30 2007/08/30
N/A N/A
N/A N/A
SA070881 Carmel PhaSeal Protector 14, 21 and 50 (Item No. P14, P21 and P50)
Medical Device Control Office
98
Department of Health The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - July 2007
Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. No. Description of Product Source of Information MHRA Boston Scientific(HK) Ltd FDA FDA FDA FDA FDA MHRA MHRA MHRA MHRA MHRA MHRA Boston Scientific(HK) Ltd Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Reference No. by Source 2007/006/020/601/002 N/A Z-0977-2007 Z-0976-2007 Z-0978-2007 Z-0985-2007 to Z-0986-2007 Z-0740-2007 to Z-0742-2007 2007/002/020/401/006 2007/006/025/061/002 2007/006/029/291/010 2007/007/002/291/004 2007/006/029/291/003 2007/007/003/291/024 N/A 35306 35880 35784 34690 34805 35772 35874 35299 35590 35779 Alert Type by Source FSCA Firm Initiated Field Action Class II Class II Class II Class II Class II FSCA FSCA FSCA FSCA FSCA FSCA Firm Initiated Field Action Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Date of Issue (YYYY/MM/DD) 2007/07/03 2007/07/03 2007/07/05 2007/07/05 2007/07/05 2007/07/05 2007/07/05 2007/07/05 2007/07/05 2007/07/06 2007/07/06 2007/07/06 2007/07/06 2007/07/09 2007/07/10 2007/07/10 2007/07/10 2007/07/10 2007/07/10 2007/07/10 2007/07/10 2007/07/10 2007/07/10 2007/07/10 Local Agent Abbott Laboratories Ltd. Boston Scientific (HK) Ltd Roche Diagnostics (Hong Kong) Limited GE Medical Systems Hong Kong Ltd. Varian Medical Systems Pacific Inc. Sanko Medical System (HK) Ltd N/A Philips Electronics Hong Kong Ltd. Abbott Laboratories Ltd. Baxter Healthcare Ltd Baxter Healthcare Ltd Varian Medical Systems Pacific Inc. N/A Boston Scientific (HK) Ltd Johnson & Johnson Medical Hong Kong Johnson & Johnson Medical Hong Kong N/A Siemens Ltd. Siemens Ltd. Bayer Healthcare Ltd. (Hong Kong) Abbott Laboratories Ltd. Abbott Laboratories Ltd. N/A N/A Agent Contact Telephone No 2806 4201 2960 7128 2485 7510 2783 1838 2724 2836 2384 0688 N/A 2876 7525 2806 4201 2807 8517 2807 8517 2724 2836 N/A 2960 7128 2738 2818 2738 2818 N/A 2810 7533 2810 7533 2814 4829 2806 4201 2806 4201 N/A N/A
SA070701 Abbott m2000sp Instrument and m1000 Instrument SA070702 Boston Scientific Polaris DXTM Sterrable Diagnostic Catheters SA070703 Roche Cortisol Reagent SA070704 GE Healthcare Diamond Mannographic X-Ray System SA070705 Varian Medical LINAC Scapel Treatment Planning System SA070706 Toshiba Aplio 80 and Aplio 50 Digital Ultrasound System SA070707 Oasis Disposable Bimanuals Irrigation and Aspiration Set SA070708 Philips Masimo SPO2 modules SA070709 Abbott ClearStar enteral feeding pump SA070710 Baxter CS3000 Apheresis Kits SA070711 Baxter Sample First Sampling System SA070712 Varian Clinacs with Type 3 accessories SA070713 Integra Neurosciences Elektrotm ET630 and ET621 Boston Scientific VASOVIEWR UniportR Plus EVH System w/ SA070714 Bisector VasoView 7xB Bisector SA070715 Ortho-Clinical Diagnostics Vitros Chemistry Products 5, 1 FS Chemistry System - Software
Ortho-Clinical Diagnostics Reagent Red Blood Cells Ficin Panel SA070716 System resolve Panel C SA070717 Teleflex Medical Non Absorbable Stainless Steel Suture SA070718 Siemens Medical Simview 3000 and Simview NT SA070719 Siemens Medical Linear Accelerators SA070720 Bayer Healthcare Ascencia Contour Blood Glucose Meter Abbott Axsym System - Quinidine Assay and X Systems Quinidine SA070721 Assay SA070722 Abbott Architect System - Analyzer - Class 2 SA070723 Elekta Precise Plan SA070724 Gyrus CyberWand Ultrasonic Lithotriptor
Medical Device Control Office
99
Department of Health The Government of HKSAR
SA070725 Chiltern Wispa Attachment Handle SA070726 Airox Legendair Ventilator SA070727 AMO VISX WaveScan WaveFront Systems SA070728 Pride Mobility Power Chairs Jazzy 610, 1107, 1650 and Quantum 610, 1107
Health Canada Health Canada MHRA MHRA MHRA MHRA FDA FDA FDA FDA FDA FDA FDA FDA FDA MHRA Boston Scientific(HK) Ltd MHRA MHRA BD MHRA Boston Scientific(HK) Ltd FDA FDA FDA FDA FDA
34860 35588 2007/006/028/061/010 2006/008/017/301/002 2007/003/002/401/004 2007/004/024/291/010 Z-0848-2007 to Z-0852-2007, Z-0928-2007 Z-0991-2007 Z-1002-2007 to Z-1005-2007 Z-0929-2007 to Z-0930-2007 Z-0966-2007 Z-0853-2007 Z-0987-2007 Z-0738-2007 Z-0975-2007 2007/007/009/061/005
Type I Type I FSCA FSCA FSCA FSCA Class II Class II Class II Class II Class II Class II Class II Class II Class II FSCA Firm Initiated Field Action
2007/07/10 2007/07/10 2007/07/10 2007/07/10 2007/07/11 2007/07/11 2007/07/12 2007/07/12 2007/07/12 2007/07/12 2007/07/12 2007/07/12 2007/07/12 2007/07/12 2007/07/12 2007/07/13 2007/07/13 2007/07/17 2007/07/17 2007/07/17 2007/07/18 2007/07/18 2007/07/19 2007/07/19 2007/07/19 2007/07/19 2007/07/19
N/A Forever Health Medical Instrument Ltd AMO Asia Limited N/A N/A N/A GE Medical Systems Hong Kong Ltd. Smiths Medical (S.E. Asia) Ltd. Terumo China (H.K.) Ltd. Terumo China (H.K.) Ltd. N/A N/A Philips Electronics Hong Kong Ltd. Kodak (Hong Kong) Ltd N/A N/A Boston Scientific (HK) Ltd N/A Siemens Ltd. BD N/A Boston Scientific (HK) Ltd Terumo China (H.K.) Ltd. Abbott Laboratories Ltd. Abbott Laboratories Ltd. N/A GE Medical Systems Hong Kong Ltd.
N/A 2770 9922 2480 3330 N/A N/A N/A 2783 1838
SA070729 AIDAPT Coniston Swivel Bathers SA070730 AIDAPT Solo Bed Rail GE OEC 9900 Elite, OEC 9800, OEC 8800, OEC 6800, OEC 2800 SA070731 mobile AND oec Miniview 6800 mobile Fluoroscopic x-ray system SA070732 Smiths Medical Pneupac VR1 Standard and VR1 Responder SA070733 Terumo Perfusion System 8000 Roller Pump, Model 8000 and Perfusion System 9000 Roller Pump Model 9000
2866 0811 2866 0811 N/A N/A 2876 7525
SA070734 Terumo Advanced Perfusion System 1 Model 801763 and 801764 SA070735 Invacare Storm TDX Power Wheelchair SA070736 Diagnostica Stago STA Liatest VWF: Ag SA070737 Philips Medical HDIIXE Diagnostic Ultrasound System SA070738 Kodak Direct View DR7500 System SA070739 Radiometer Medical SafeClinitubes SA070740 Instersurgical Solus Flexible Wire-Reinforced Airway SA070741 Boston Scientific 6 French Guider Catheter Arizant Ranger Standard Flow Blood/Fluid Warming Disposable SA070742 Sets SA070743 Siemens CENTRA Active BTE Hearing Instrument SA070744 BD Trypticase Soy Agar dehydrated culture media SA070745 Molnlycke Procedure Tray - Extraction of Wisdom Teeth SA070746 Boston Scientific Mach 1 Guide Catheter SA070747 Terumo TenderFlow Pediatric Arterial Cannulae SA070748 Abbott Patrol Enteral Pump Set SA070749 Abbott AxSYM Troponin-I ADV Reagent Pack SA070750 Ossur Total Knee Model Number 2100 SA070751 GE Healthcare OEC 9900 ESP-15 Elite and OEC 9800 ESP-15 CArm Fluoroscopic X-Ray System
N/A N/A 2960 7128 N/A 2810 7533 2575 8668 N/A 2960 7128 2866 0811 2806 4201 2806 4021 N/A 2783 1838
2007/006/029/601/004 2007/004/018/601/810
FSCA FSCA Firm Initiated Field Action
2007/007/005/051/003
FSCA Firm Initiated Field Action
Z-0874-2007 to Z-0885-2007 Z-0888-2007 Z-1023-2007 to Z-1040-2007 Z-1076-2007 Z-0989-2007 to Z-0990-2007
Class II Class II Class II Class II Class II
Medical Device Control Office
100
Department of Health The Government of HKSAR
SA070752
GE Healthcare Innova 2100 IQ and Innova 3100/3100IQ Fluoroscopic Imaging System
FDA FDA FDA Boston Scientific(HK) Ltd FDA
Z-1043-2007 to Z-1044-2007 Z-1075-2007 Z-1008-2007 N/A N/A
Class II Class II Class II Firm Initiated Field Action Press Release
2007/07/19 2007/07/19 2007/07/19 2007/07/20 2007/07/23 2007/07/24
GE Medical Systems Hong Kong Ltd. N/A N/A Boston Scientific (HK) Ltd Baxter Healthcare Ltd N/A Roche Diagnostics (Hong Kong) Limited Roche Diagnostics (Hong Kong) Limited Philips Electronics Hong Kong Ltd. Agfa Hong Kong Limited N/A Agfa Hong Kong Limited N/A Varian Medical Systems Pacific Inc. Roche Diagnostics (Hong Kong) Limited N/A N/A N/A Maquet Hong Kong Limited N/A N/A N/A Science International Corp Medtronic International, Ltd.
2783 1838 N/A N/A 2960 7128 2807 8555 N/A 2485 7510 2485 7510 2876 7525 2555 9421 N/A 2555 9421 N/A 2724 2836 2485 7510 N/A N/A N/A 2393 9511 N/A N/A N/A 2543 7442 2919 1362
SA070753 Cardinal Health AirLife nCPAP System Driver SA070754 Anspach Single Use, Sterile Bone Cutting Burrs SA070755 Boston Scientific AccuStick II with 0.38" Stainless Steel J Tip and .18" Nitinol Guidewire
SA070756 Baxter Colleague Triple Channel Volumetric Infusion Pumps SA070757 Teleflex Infant Nasal CPAP Cannulae/Systems SA070758 Roche Elecsys Digoxin (Product No. 1182079322) SA070759 Roche PSM QC and Validation Modules SA070760 Philips Heartstart XL Monitor/Defibrillator AGFA OT3000 Orthopaedic Workstation, MA3000 Mammographic SA070761 Workstation, Impax DS3000 SA070762 Cryolife Bioglue Rigid Applicator Tips SA070763 Agfa Heartlab Cardiovascular SA070764 Instrumentation Laboratory ACL TOP Coagulation Analyzer SA070765 Varian RadioCamera System SA070766 Roche Amplilink SA070767 Elekta Precise Destop Release 4.2/5.0 SA070768 Teleflex Medical Capio PGA Suture and Polyester Non-Absorbable Suture
Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada MHRA MHRA MHRA MHRA MHRA MHRA
35510 35915 36081 36232 35406 36244 36144 35986 35912 35828 36080 35473 2007/011/021/401/007 2007/007/016/291/007 2007/006/004/601/001 2007/007/006/061/008 2007/007/019/291/007 2007/002/001/401/009
Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II FSCA FSCA FSCA FSCA FSCA FSCA
2007/07/25 2007/07/25 2007/07/25 2007/07/25 2007/07/25 2007/07/25 2007/07/25 2007/07/25 2007/07/25 2007/07/25 2007/07/25 2007/07/25 2007/07/25 2007/07/25 2007/07/27 2007/07/27 2007/07/27 2007/07/27
Walter Lorenz Dual Rail Distractor, Flex QC Shaft Extension, SA070769 Pediatric Distractor, QC Patient Driver, QC Removal Tool, QC Shaft Extension, QC Solid Shaft Removal Tool SA070770 Maquet KION/KION-I Anasthesia Workstation SA070771 Universal Hospital Supplies Ltd Sterile Suction Connecting Tubing SA070772 nSpire Gas Delivery hoses SA070773 Stapeline circular stapler and hemorrhoidal stapler SA070774 HemoCue Glucose 201 RT System SA070775 Medtronic N'Vision InterStim-B Software, N'Vision Clinician Programmer, InterStim iCon Patient Programmer, InterStim Implantatble Neurostimuator, InterStim II Implantable Neurostimulator Baxter COLLEAGUE, COLLEAGUE CX, and FLO-GARD volumetric infusion pumps
SA070776
FDA
Class I
2007/07/27
Baxter Healthcare Ltd
2807 8555
Medical Device Control Office
101
Department of Health The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - June 2007
Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. No. Description of Product Source of Information MHRA MHRA MHRA BD Kimberly Clark Health Care MHRA MHRA MHRA FDA MHRA MHRA Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada MHRA MHRA MHRA Reference No. by Source MDA/2007/043 2007/005/024/061/012 2007/002/019/401/010 N/A N/A 2007/005/031/061/014 2007/004/011/051/001 2007/005/031/051/010 Z-0833-2007 to Z-0835-2007 2007/006/004/051/016 2007/006/006/061/002 35431 35223 34829 34820 34533 35132 2007/005/009/061/008 2007/005/031/051/005 MDA/2007/049 Alert Type by Source MDA FSCA FSCA Firm Initiated Field Action Firm Initiated Field Action FSCA FSCA FSCA Class II FSCA FSCA Type II Type II Type II Type II Type II Type II FSCA FSCA MDA 2007/06/12 2007/06/12 2007/06/12 2007/06/08 2007/06/11 2007/06/12 2007/06/12 2007/06/12 2007/06/12 2007/06/12 2007/06/12 SA070617 Bio-Rad Gelose MRSA Select REF63747, LOT7C1025 SA070618 Invivo Precess (3160 Series) MRI Compatible Patient Monitoring System Bio-Rad Pacific Ltd. N/A N/A BD 2789 3300 N/A N/A 2575 8668 2007/06/04 2007/06/04 2007/06/04 2007/06/05 2007/06/05 2007/06/06 2007/06/07 N/A Medtronic International, Ltd. Zenith Medical Co. Ltd Siemens Ltd. Fujifilm Hong Kong Limited N/A N/A Specialists' Dental Supplies Limited N/A 2919 1362 2720 2727 2810 7533 2317 0848 N/A N/A N/A Date of Issue (YYYY/MM/DD) 2007/06/01 2007/06/04 Baxter Healthcare Ltd Olympus Hong Kong Ltd BD Goodman Medical Supplies Ltd Roche Diagnostics (Hong Kong) Limited Smiths Medical (S.E. Asia) Ltd. Maquet Hong Kong Limited 2807 8556 2376 1805 2575-8668 2332 4455 2485 7510 2317 0988 2393 9511 Local Agent N/A Agent Contact Telephone No N/A
SA070601 Invacare Flamingo mobile patient hoists SA070602 SA070603 SA070604 SA070605 Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis System Olympus CRP Latex OSR6x99 and Ferritin OSR6x50/OSR6x138 Reagents BD BBL Trypticase Soy Agar w/5% Sheep Blood (TSA II) // MacConkey II Agar I Plate Kimberly Clark Health Care Microcuff Pediatric Oral/Nasal Magill endotracheal tube
SA070606 Roche COBAS Taqman HCV and HIV-1 Test SA070607 Smiths Medical Level 1 H-1200 Fast Flow Fluid Warmer User and H-31B Air Detector/Clamp User
SA070608 MAQUET Mobile O.R. table 1131.12XO, BETASTAR SA070609 Kensey Nash TriActiv FX Embolic Protection System, FX Spare Shieldwire Inflators, ProGuard Spare Shieldwire Inflators
SA070610 Medtronic Strata NSC Lumboperitoneal Shunt Kit SA070611 Clearview HCG Test Kits (Product Code 500158, Kit Lot no. HG0050)
SA070612 Siemens AG Sienet Magicstore SA070613 Fujifilm FCR Velocity U and DR Velocity UFP SA070614 Electric Mobility Rascal Power Chair and Turnabout Power Chair SA070615 Sendx Medical (Radiometer Capenhagen ) ABL80 Flex Analyzer SA070616 Biohorizons Implant Systems Complete OP & OS Surgical Kit
SA070619 WALLACH T-00337 Anorectal Tip SA070620 BD Microtainer Safety Flow Lancets
Medical Device Control Office
102
Department of Health The Government of HKSAR
SA070621 Boston Scientific SwissLithoclast Ultra Sound Handpiece Kit SA070622 Boston Scientific Impulse Angiographic Catheter SA070623 ev3 Amplatz Goose Neck Snare Kit SA070624 Wright Medical Profemur R, Revision Hip System SA070625 Surge Medical Solutions 15 Fr. Retrograde Cardioplegia Cannula SA070626 Roche VANC2 Online TDM Vancomycin SA070627 Varian Medical FramelessArray Software version 1.0 SA070628 Siemens Medical c.cam Gamma Camera, Model 9VIR1200 SA070629 Hawaii Medical NeatNick Sweeping Action Hell Lancet SA070630 Sunrise Medical Groove Power Wheelchairs SA070631 Schiller Easyport Defibrillators SA070632 B Braun Intrapur Neonat Lipid I.V. Filter SA070633 Smith & Nephew PERI-LOC 2.5mm Self Tapping Locking Cortex Screw
Boston Scientific(HK) Ltd Boston Scientific(HK) Ltd MHRA FDA FDA FDA FDA FDA FDA MHRA MHRA MHRA MHRA Boston Scientific(HK) Ltd FDA FDA FDA FDA FDA MHRA MHRA Bausch & Lomb (Hong Kong) Ltd. MHRA Health Canada Health Canada
N/A N/A 2007/006/006/061/023 Z-0867-2007 to Z-0868-2007 Z-0892-2007 to Z-0904-2007 Z-0919-2007 to Z-0920-2007 Z-0905-2007 Z-0906-2007 Z-0926-2007 to Z-0927-2007 2007/004/017/601/805 2007/006/005/051/020 2007/006/012/061/008 2007/005/018/601/919 N/A Z-0922-2007 Z-0959-2007 Z-0960-2007 to Z-0965-2007 Z-0935-2007 Z-0936-2007 2007/005/025/061/005 2007/006/013/061/001 N/A 2007/003/029/601/731 35442 35427
Firm Initiated Field Action Firm Initiated Field Action FSCA Class II Class II Class II Class II Class II Class II FSCA FSCA FSCA FSCA Firm Initiated Field Action Class II Class II Class II Class II Class II FSCA FSCA Firm Initiated Field Action FSCA Type II Type I
2007/06/12 2007/06/12 2007/06/13 2007/06/14 2007/06/14 2007/06/14 2007/06/14 2007/06/14 2007/06/14 2007/06/14 2007/06/15 2007/06/15 2007/06/20 2007/06/20 2007/06/21 2007/06/21 2007/06/21 2007/06/21 2007/06/21 2007/06/21 2007/06/21 2007/06/21 2007/06/22 2007/06/25 2007/06/25
Boston Scientific (HK) Ltd Boston Scientific (HK) Ltd Conmed Ltd Starry Medical Technology Ltd N/A Roche Diagnostics (Hong Kong) Limited Varian Medical Systems Pacific Inc. Siemens Ltd. N/A N/A N/A N/A Smith & Nephew Healthcare Ltd. Boston Scientific (HK) Ltd N/A N/A Suntime Technology Ltd N/A N/A N/A N/A Bausch & Lomb (Hong Kong) Ltd. Smiths Medical (S.E. Asia) Ltd. N/A Forever Health Medical Instrument Ltd
2960 7128 2960 7128 2854 4413 2381 0279 N/A 2485 7510 2724 2836 2810 7533 N/A N/A N/A N/A
2645 8703 2960 7128 N/A N/A 2758 8075 N/A N/A N/A N/A 2213 3178 2317 0988 N/A 2770 9922
SA070634 Boston Scientific Transend EX Guidewire SA070635 Biomet 3i EP Healing Abutment SA070636 Biomet 3i disposable twist drills SA070637 Synovis Peri-Strips Dry Staple Line Reinforcement SA070638 Porous Media HUMIDIFLOW Respiratory Gas Humidifier SA070639 Zoll Lifecor Electrode Belt SA070640 Bio-Diagnostics GBM Quantitative ELISA Kit SA070641 Thoratec TLC-II Portable VAD Driver SA070642 Bausch & Lomb Zyoptix Epi Separator and Zyoptix XP Epi Head SA070643 Smiths Medical Pneupac VR1 Ventilatory Resucitator SA070644 Sunrise Quickie SA070645 Airox Legendair Ventilator Single/Double Bran
Medical Device Control Office
103
Department of Health The Government of HKSAR
SA070646 Walter Lorenz Bone File SA070647 Beckman Coulter Flow Count Fluorospheres Beckman Coulter Cytomics FC 500 Flow Cytometer (CXP Version SA070648 2.1 and 2.2) SA070649 BD Multivisc 2.5% Viscoadaptive solution SA070650 Inpeco Accelerator Aps System SA070651 Oxoid Metronidazole 10ug disc SA070652 Apex Hoy-advance-e SA070653 Edwards Lifesciences Vigilance II Monitor Horiba ABX Pentra Myoglobin CP Reagent, ABX Pentra Ferritin CP SA070654 Reagent SA070655 Fresenius Medical Care AV Set FMC (FA404E/FV404E) SA070656 Mediplus Coventry Valve Triple IV Peripheral Connector Set SA070657 Abbott ARCHITECT i2000 Processing Module (List# 08C89-01, 3M74-01, 1G06-01 & 3L77-01)
Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada MHRA MHRA MHRA MHRA FDA FDA FDA MHRA Boston Scientific(HK) Ltd MHRA MHRA Cyberonics
35636 35682 35691 34172 35448 35291 34534 2007/006/013/061/012 2007/006/020/061/001 2007/005/008/601/880 2006/012/007/601/455 Z-0950-2007 to Z-0953-2007 Z-0967-2007 Z-0956-2007 MDA/2007/056 N/A 2007/006/026/291/010 2007/006/026/291/013 N/A
Type II Type II Type II Type II Type II Type II Type II FSCA FSCA FSCA FSCA Class II Class II Class II MDA Firm Initiated Field Action FSCA FSCA Firm Initiated Field Action
2007/06/25 2007/06/25 2007/06/25 2007/06/25 2007/06/25 2007/06/25 2007/06/25 2007/06/25 2007/07/26 2007/06/27 2007/06/27 2007/06/28 2007/06/28 2007/06/28 2007/06/28 2007/06/28 2007/06/29 2007/06/29 2007/06/29
N/A Beckman Coulter Hong Kong Ltd. Beckman Coulter Hong Kong Ltd. BD N/A N/A N/A N/A N/A Fresenius Medical Care Asia Pacific Ltd. N/A Abbott Laboratories Ltd. Swedish Trading Co., Ltd Roche Diagnostics (Hong Kong) Limited N/A Boston Scientific (HK) Ltd Medtronic International, Ltd. N/A GM Medical (Hong Kong) Ltd
N/A 2240 6260 2240 6260 2575 8668 N/A N/A N/A N/A N/A N/A N/A 2806 4201 N/A 2485 7510 N/A 2960 7128 2919 1362 N/A 2521 9799
SA070658 Steris QFC1728 and QFC1729 Quick Connects SA070659 Roche MagNA Pure LC Total Nucleic Acid Isolation Kit SA070660 Invacare Scanbed 750 (SB750) SA070661 Boston Scientific Capio Sutures SA070662 Medtronic Biphasic LIFEPAK 500 AEDs SA070663 Oasis Medical Premier Edge Disposable Knives SA070664 Cyberonics VNS Therapy Leads (Model 300, 302, 303)
Medical Device Control Office
104
Department of Health The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - May 2007
Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. No. Description of Product Source of Information MHRA FDA MHRA Boston Scientific (HK) Ltd FDA MHRA MHRA MHRA MHRA FDA FDA FDA FDA FDA FDA MHRA MHRA MHRA MHRA Medtronic International, Ltd. MHRA Health Canada Reference No. by Source 2007/004/025/291/009 Z-0759-2007 2007/004/020/291/007 N/A N/A 2007/004/027/291/017 2007/003/030/601/744 2007/005/002/061/009 2006/009/004/291/005 Z-0773-2007 to Z-0776-2007 Z-0771-2007 Z-0783-2007 Z-0778-2007 Z-0772-2007 Z-0779-2007 2006/011/016/291/003 2007/003/029/291/013 MDA/2007/035 MDA/2007/034 N/A 2006/010/012/301/003 34992 Alert Type by Source FSCA Class II FSCA Firm Initiated Field Action N/A FSCA FSCA FSCA FSCA Class II Class II Class II Class II Class II Class II FSCA FSCA Medical Device Alert Medical Device Alert Firm Initiated Field Action FSCA Type I 2007/05/11 2007/05/11 2007/05/11 2007/05/11 2007/05/14 Date of Issue (YYYY/MM/DD) 2007/05/02 2007/05/03 2007/05/03 2007/05/03 2007/05/04 2007/05/07 2007/05/07 2007/05/09 2007/05/09 2007/05/10 2007/05/10 2007/05/10 2007/05/10 2007/05/10 2007/05/10 2007/05/10 2007/05/10 N/A N/A Olympus Hong Kong Ltd Medtronic International, Ltd. N/A GM Medical Pacific Ltd N/A N/A 2376 1805 2919 1362 N/A 2783 1838 Local Agent N/A N/A N/A Boston Scientific (HK) Ltd Johnson & Johnson Medical Hong Kong Beckman Coulter Hong Kong Ltd. Smith & Nephew Healthcare Ltd. Baxter Healthcare Ltd N/A Biomerieux (Hong Kong) Sanko Medical Systems (H.K.) Ltd. B. Braun Medical (Hong Kong) Ltd. Vastec medical Ltd N/A N/A Tyco Healthcare (HKSAR) Limited Agent Contact Telephone No N/A N/A N/A 2960 7128 2738 2818 2240 6260
SA070501 ResMed S8 CPAP Devices SA070502 Medi Prosthetic Knee Joint SA070503 Endoart EasyBand Boston Scientific NexStentR Carotid Stent and Monorail Delivery SA070504 System SA070505 SA070506 SA070507 Ortho- Clinical Diagnostics VITROS troponin I reagent packs (Cat. No.: 194 9882) Beckman Coulter COULTER LH750 Analyzer, COULTER LH780, COULTER LH500 Series System, COULTER GEN.S Smith & Nephew Reflection All Poly Acetabular Cup (Product Code 71353255 06DT97293)
2645 8703 28078556 N/A 2356 7033 2384 0688 2277 6125 2897 1912 N/A N/A 3157 7244
SA070508 Baxter UV Flash Compact Device SA070509 Hill-Rom AvantGuard Electtic Bed BioMerieux BacT/ALERT Classic System Software, Blood Culturing SA070510 System Toshiba Nemio XG, Ultrasound system SSA-590A with version 1.5 software B.Braun HyperFormer Pump Dispensing Set (Catalog No V9900SA070512 02) SA070511 SA070513 Instrumentation Laboratory GEM Premier 4000 Laboratory Analyzer SA070514 Graham-Field Lumex Walkabout Lite Four-Wheel Rollator American Diagnostica Inc ACTICLOT Dpt Reference 824 in vitro SA070515 diagnostic SA070516 SA070517 Tyco Healthcare SealGuard TracheoSoft and SealGuard TracheoSoft PERC Edwards Lifesciences CO-Set + Closed Injectate Delivery System for Cold Injectate (Model 93600)
SA070518 AFOS All endoscope storage facilities (ESF) SA070519 Olympus Flexible endoscopes SA070520 Medtronic MiniMed insulin infusion pumps SA070521 JCM Supportive seating system SA070522 Thoratec - Paracorporeal ventricular assist device
Medical Device Control Office
105
Department of Health The Government of HKSAR
SA070523 Datex-Ohmeda TEC 6 Plus Desflurane Vaporizer SA070524 GE Healthcare Revolution XR/D SA070525 GE Medical System CIC Pro Central Station SA070526 Conmed PET Eliminator Balloon Dilator SA070527 AMG Medpro Lubricating Gel SA070528 Stryker 3.5mm 90-S Serfas Energy Suction Probe SA070529 Boston Scientific Maverick 2 Monorail Balloon Catheter Boston Scientific System Drape (IVUS motor drive sterile plastic SA070530 cover) SA070531 Medical Wire and Equipment Customers Microrings SA070532 Arjo Maxi Move Patient Lift with Scale SA070533 Ethicon Gynecare PROLIFT Total Pelvic Repair System SA070534 CIBASoft Visitint Soft Contact Lenses SA070535 Medtronic LIFEPAK 20 Defibrillator/Monitor SA070536 Vygon V-GREEN Narrow Bore Ext Line with Clamp SA070537 BD FACSCanto and FACSCanto II Software SA070538 Olympus Clinical Chemistry Analyser Software version V5.3A SA070539 Olympus Triglyceride Reagent DIAGMED ENTERAL Covered Duodenal Stent (Codes NDC-18-90SA070540 180 & NDC-18-110-180) SA070541 Conor Medsystems CoStar drug-eluting coronary stents Homecraft Rolyan Bathmaster 2000, Bathmaster Classic, SA070542 Bathmaster Xtra and Bathmaster Reclina (bath lift hand controls) SA070543 Nightingale Pro Axis and Pro Axis Plus SA070544 MEDEX DPS Kids Kit (Pediatric) Secure System SA070545 BREAS PV403 PEEP Viasys all paediatric ventilator breathing systems containing water SA070546 trap SA070547 Abbott FLEXIFLO DURA-PEG Kit SA070548 Cranex Tome panoramic x-ray unit
Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Boston Scientific(HK) Ltd Boston Scientific(HK) Ltd MHRA FDA FDA FDA MHRA MHRA MHRA MHRA MHRA MHRA Johnson & Johnson MHRA MHRA MHRA MHRA MHRA MHRA FDA
33552 34525 34840 34868 34958 34918 N/A N/A 2007/005/003/061/014 Z-0796-2007 to Z-0799-2007 Z-0795-2007 Z-0793-2007 2007/005/002/061/006 2007/005/011/291/002 2007/005/010/291/006 2007/005/010/061/013 2007/005/010/061/009 2007/004/025/291/018 N/A MDA/2007/039 MDA/2007/038 2007/005/016/291/014 2007/005/014/061/009 MDA/2007/037 2007/005/014/061/019 Z-0816-2007
Type II Type II Type II Type II Type II Type II Firm Initiated Field Action Firm Initiated Field Action FSCA Class II Class II Class II FSCA FSCA FSCA FSCA FSCA FSCA N/A Medical Device Alert Medical Device Alert FSCA FSCA Medical Device Alert FSCA Class II
2007/05/14 2007/05/14 2007/05/14 2007/05/14 2007/05/14 2007/05/14 2007/05/15 2007/05/15 2007/05/15 2007/05/17 2007/05/17 2007/05/17 2007/05/18 2007/05/18 2007/05/18 2007/05/18 2007/05/18 2007/05/18 2007/05/18 2007/05/22 2007/05/22 2007/05/22 2007/05/22 2007/05/22 2007/05/23 2007/05/25
GE Medical Systems Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. N/A N/A Stryker China Ltd Boston Scientific (HK) Ltd Boston Scientific (HK) Ltd N/A Arjo Far East Ltd (Hong Kong) Johnson & Johnson Medical Hong Kong Ciba Vision (Hong Kong) Ltd. Medtronic International, Ltd. N/A BD Olympus Hong Kong Ltd Olympus Hong Kong Ltd N/A Biotronik Hong Kong N/A N/A Smiths Medical (S.E. Asia) Ltd. N/A Viasys Healthcare Hong Kong Ltd Abbott Laboratories Ltd. Umedco
2783 1838 2783 1838 2783 1838 N/A N/A 2518 6988 2960 7128 2960 7128 N/A 2508 9553 2738 2818 2814 2121 2919 1362 N/A 2575 8668 2376 1805 2376 1805 N/A 2877 6787 N/A N/A 2317 0988 N/A 2893 0873 2806 4201 2765 8222
Medical Device Control Office
106
Department of Health The Government of HKSAR
SA070549
GE Americas Signa 3.0T EXCITE Whole Body Magnetic Resonance System
FDA FDA FDA FDA MHRA MHRA MHRA Abbott Laboratories Ltd. FDA Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada
Z-0815-2007 Z-0814-2007 Z-0812-2007 Z-0810-2007 2007/004/010/301/003 MDA/2007/040 2007/002/001/301/001 N/A N/A 34875 34511 34276 34874 34652 35215 35094 35032
Class II Class II Class II Class II FSCA Medical Device Alert FSCA Firm Initiated Field Action CDC Type I Type I Type II Type II Type II Type II Type II Type II
2007/05/25 2007/05/25 2007/05/25 2007/05/25 2007/05/25 2007/05/25 2007/05/25 2007/05/25 2007/05/28 2007/05/28 2007/05/28 2007/05/28 2007/05/28 2007/05/28 2007/05/28
GE Medical Systems Hong Kong Ltd. Biomerieux (Hong Kong) N/A Roche Diagnostics (Hong Kong) Limited N/A Draeger Medical Hong Kong Ltd. GNB Technologies (China) Ltd Abbott Laboratories Ltd. AMO Asia Limited Roche Diagnostics (Hong Kong) Limited N/A N/A B. Braun Medical (Hong Kong) Ltd. N/A Philips Electronics Hong Kong Ltd.
2783 1838 2356 7033 N/A 2485 7510 N/A 2877 3077 N/A 2806 4201 2480 3330 2485 7510 N/A N/A 2277 6125 N/A 2876 7525 2876 7525 N/A
SA070550 BioMerieux BacT/VIEW Software, all versions. SA070551 Diagnostic Stago STA Compact and STA Compact CT SA070552 Roche PTH (Parathyroid Hormone Test system ) SA070553 Sunrise Medical GROOVE 10KPH & 13 KPH Models Wheelchairs SA070554 Draeger Medical Primus anaesthetic workstation SA070555 EXIDE Technologies Mentzer 24V 6A Konstant Charger SA070556 Abbott ARCHITECT STAT Troponin-I test products SA070557 AMO COMPLETE MoisturePLUS Multi-Purpose Solution SA070558 Roche COBAS Integra System Valproic Acid SA070559 T.H.E. Medical Reacher Bar with Small Carabiner SA070560 Randox Laboratories Assayed Bovine Serum SA070561 B.Braun Ultrasite Horizon Pump IV Set SA070562 Dentsply Protper Obturators Philips Medical (1) Achieve 1.5T MRI System (2) Gyroscan SA070563 Magnetic System ACS-NT (3) Gyroscan Magnetic System T10-NT (4) Intera 3.0T MRI System (5)Intera 1.5 Master MR SA070564 Philips HD11 Ultrasound System Conmed Linvatec Medical Devices Packaged within certain Peel SA070565 Pouch Sterile Packages Beckman (1) Synchro LX20Pro (2) Synchron LX20 System SA070566 Analyzer (3) Synchron LXI725 (4) Unical DXC 600 (5) Unical DXC 6001 Analyzer (6) Unical DXC80. SA070567 BIODIS VerifyNow P2Y12 SA070568 Medtronic Advantage Heart Valves A7760, A7760SA, M7760 SA070569 BD Infusion Therapy System (Angiocath Catheter) Inverness Medical BinaxNOW (a) Influenza A&B 10 Test Kit (b) SA070570 Influenza A&B 22 Test kit (c) RSV 10 Test kit (d) Nasopharyngeal Accessory pak (e) A&B Kit 10 Test kit (Japan) SA070571 GE Medical Definium AMX 700 Digital mobile x-ray system SA070572 Abbott Precision Link Software (version 2.1 - 2.6) SA070573 CP Medical Surgical Suture SA070574 Corin Taper-Fit (12/14 Eurocone) Hip Stem
2007/05/28 2007/05/28 2007/05/28
Philips Electronics Hong Kong Ltd. N/A
Health Canada MHRA Medtronic International, Ltd. BD FDA FDA FDA FDA MHRA
35003 2007/003/026/291/004 N/A N/A Z-0822-2007 to Z-0826-2007 Z-0821-2007 Z-0709-2007 Z-0807-2007 2007/005/022/061/006
Type II FSCA Firm Initiated Field Action Firm Initiated Field Action Class II Class II Class II Class II FSCA 2007/05/31 2007/05/31 2007/05/31 2007/05/31 2007/05/29 2007/05/29 2007/05/29 2007/05/31
Beckman Coulter Hong Kong Ltd. N/A Medtronic International, Ltd. BD N/A GE Medical Systems Hong Kong Ltd. Abbott Laboratories Ltd. N/A N/A
2240 6260 N/A 2919 1362 2575 8668 N/A 2783 1838 2806 4201 N/A N/A
Medical Device Control Office
107
Department of Health The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - April 2007
Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. No. SA070401 Description of Product Siemens Medical Solutions IMMULITE One TNF-Alpha Lot 147 (LKNF 147) Source of Information MHRA MHRA MHRA MHRA MHRA Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Reference No. by Source 2007/003/028/601/729 2007/003/029/181/004 2007/002/006/081/001 2007/003/016/291/002 2007/003/022/601/706 32004 33345 345,133,451,434,517 34484 33329 34519 34536 34277 34448 34510 34214 Alert Type by Source FSCA FSCA FSCA FSCA FSCA Type II Type II Type II Type II Type II Type II Type II Type II Type II Type I Type II Date of Issue (YYYY/MM/DD) 2007/04/02 2007/04/03 2007/04/03 2007/04/04 2007/04/04 2007/04/10 2007/04/10 2007/04/10 2007/04/10 2007/04/10 2007/04/10 2007/04/10 2007/04/10 2007/04/10 2007/04/10 2007/04/10 Local Agent Siemens Ltd. GE Medical Systems Hong Kong Ltd. Smith & Nephew Healthcare Ltd. Baxter Healthcare Ltd. N/A GE Medical Systems Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. DePuy Inc (J&J) Smiths Medical (S.E. Asia) Ltd. Smiths Medical (S.E. Asia) Ltd. Siemens Ltd. Conmed Limited N/A Agent Contact Telephone No 2870 7533 2783 1838 2645 8703 2807 8556 N/A 2783 1838 2783 1838 2783 1838 2783 1838 2783 1838 2738 2894 2317 0988 2317 0988 2810 7533 2854 4413 N/A
SA070402 GE Healthcare OEC 9900 SA070403 Smith & Nephew - Birmingham Hip Resurfacing Acetabular Cups SA070404 Baxter Haemodialysis Instruments Addenda SA070405 Arcomedical Infusion Ltd - 3101-PVJ (FSB502) Needlefree solution set (Batch C8227)
SA070406 GE Healthcare Smart Box SA070407 GE Healthcare Lightspeed VCT and Lightspeed VCT Select GE Healthcare - OEC Uroview 2800, OEC Miniview 6800, OEC Flexiview 8800 GE Healthcare OEC Radiographic/Fluoroscopic Systems, Model (1) SA070409 Mini6600 (2) Uroview 2800 (3) Miniview 6800 (4) Flexiview 8800 (5) 9800 SA070410 GE Healthcare - Instatrak 3500 System SA070408 SA070411 Depuy Asr Acetabular Cup System SA070412 Smiths Medical - Fluid Warming System SA070413 Smiths Medical - Medfusion 3500 Syring Infusion Pump SA070414 Siemens Medical - Lithoskop SA070415 Conmed Padpro Adult Radiotranslucent Pad SA070416 Trudell Medical Marketing Limited - ABG kit
SA070417 Stentor (Philips Medical Systems) - Isite Pacs SA070418 Cryocath Flexcath Steerable Sheath SA070419 Dentalez Inc - End Cup SA070420 Physio-Control LIFEPAK 20 Defibrillator/Monitor
Health Canada Health Canada Health Canada Medronic International Ltd
34305 34518 34543 N/A
Type II Type II Type II Firm Initiated Field Action
2007/04/10 2007/04/10 2007/04/10 2007/04/10
Philips Electronics Hong Kong Ltd. N/A N/A Medtronic International, Ltd.
2876 7525 N/A N/A 2919 1362
Medical Device Control Office
108
Department of Health The Government of HKSAR
SA070421 Philips Medical - Brilliance Computed Tomography System SA070422 Gambro Lundia AB - Prismaflex Cont. Rental Replacement System SA070423 SA070424 Ethicon Endo-Surgery PROXIMATE PPH hemorrhoidal circular stapler Boston Scientific CONTAK RENEWAL 3 & 4 (CRT-D), VITALITY and VITALITY 2 (ICD)
Health Canada Health Canada Johnson & Johnson Medical Hong Kong Boston Scientific(HK) Ltd FDA FDA FDA FDA FDA FDA FDA FDA FDA BD MHRA FDA FDA FDA FDA FDA FDA FDA FDA FDA Boston Scientific(HK) Ltd Boston Scientific(HK) Ltd
34499 33615, 33616 N/A N/A Z-0673-2007 Z-0670-2007 Z-0686-2007 Z-0685-2007 Z-0675-2007 Z-0652-2007 Z-0647-2007 to Z-0651-2007 Z-0655-2007 to Z-0659-2007 Z-0665-2007 N/A 2007/003/028/081/005 Z-0660-2007 Z-0722-2007 Z-0719-2007 Z-0706-2007 Z-0714-2007 Z-0711-2007 to Z-0713-2007 Z-0705-2007 Z-0701-2007 Z-0720-2007 to Z-0721-2007 N/A N/A
Type II Type II N/A Firm Initiated Field Action Class II Class II Class II Class II Class II Class II Class II Class II Class II Firm Initiated Field Action FSCA Class II Class II Class II Class II Class II Class II Class II Class II Class II Firm Initiated Field Action Firm Initiated Field Action
2007/04/10 2007/04/10 2007/04/10 2007/04/11 2007/04/11 2007/04/11 2007/04/11 2007/04/11 2007/04/11 2007/04/11 2007/04/11 2007/04/11 2007/04/11 2007/04/11 2007/04/11 2007/04/11 2007/04/12 2007/04/12 2007/04/12 2007/04/12 2007/04/12 2007/04/12 2007/04/12 2007/04/12 2007/04/16 2007/04/16
Philips Electronics Hong Kong Ltd. Gambro China Ltd. Johnson & Johnson Medical Hong Kong Boston Scientific (HK) Ltd N/A N/A N/A N/A Zimmer PTE Ltd. (Hong Kong branch) Siemens Ltd. Zimmer PTE Ltd. (Hong Kong branch)
2876 7525 2576 2688 2738 2818 2690 7218 N/A N/A N/A N/A 2992 0968 2810 7533 2992 0968
SA070425 Remington Medical Prostate Biopsy needle SA070426 Intuitive brand Da Vinci S Surgical System SA070427 Aspyra Inc CyberMed Version 2.1 Pharmacy Software SA070428 NDO Surgical Plicator EPS Plication System Zimmer Trabecular Metal Reserse Shoulder System SA070429 Instrumentation Conical Reamer SA070430 Siemens syngo Dynamics 5.0 Workplace SA070431 Zimmer NexGen Complete Knee Solution Minimally Invasive Solutions MIS Technology Femoral Finishing Guid SA070432 Terumo Perfusion System 8000 Base, Model 8000 SA070433 Cook ATB Advance PTA Dilation Catheter, REF G26887 SA070434 BD 366358 LANSCET SFL GREEN Smiths Medical Level 1 H-1200 H31-B Fast flow fluid warmer users and Level 1 H31-B Air Detector/ Clamp User Intuitive Surgical 8mm EndoWrist Bipolar Maryland Instrument Part SA070436 Number: 400172-04 SA070435 SA070437 Abbott Clinical Chemistry Phosphorus in vitro diagnostic (List no 7D71-30 and 7D71-20)
Terumo China (H.K.) Ltd. 2866 0811 (1) Cook Asia (Hong Kong) Ltd.; (2) (1) 2781 0232; (2) A.R. Burkhill & Sons (Hong Kong) Ltd. 2541 1041 BD Smiths Medical (S.E. Asia) Ltd. N/A Abbott Laboratories Ltd. BD Abbott Laboratories Ltd. N/A N/A N/A N/A N/A Boston Scientific (HK) Ltd Boston Scientific (HK) Ltd 2575 8668 2317 0988 N/A 2806 4201 2575 8668 2806 4201 N/A N/A N/A N/A N/A 2960 7128 2960 7128
SA070438 BD 30ml Syringe Luer-Lok tip Sterile (Reorder number 309650) Abott CELL-DYN 3200 Dilutent / Sheath Reagent (List number SA070439 03H79-01) SA070440 Integra Biotechnical ProWord Shoulder Postoperative Dressing and Cold Therapy System (Model number AR-1625)
Cenorin ThermaSure Medical Device Drying Cabient series 130, SA070441 300 AND 1000 SA070442 SA070443 Radiometer America ABL800 FLEX Series analyzer with FLEXQ module-equipped with software version 5.2 to 5.27 Scanlan International Mobin-Uddin Vein Holder (Catalog# 1001761)
SA070444 Urologix Microwave Delivery System 2.5-3.5 AND 3.0 -5.0 SA070445 Boston Scientific Percutaneous Track Kit with Amplaz Dilator and Sheath Kit
SA0704476 Boston Scientific ObtryxR Transoburator Mid-Urethral Sling System
Medical Device Control Office
109
Department of Health The Government of HKSAR
SA0704476 Boston Scientific RigiflexT II- Single Use Achalasia Ballon Dilators SA070448 HemoCue Glucose Systems SA070449 Abbott TDx/TDxFLx Methotrexate Reagent (List no 07A12-60) SA070450 LifeScan One Touch Ultra blood glucose test strips BIOMET 3i Conical 17 Degree Angeled Abutment 4.1mm (D) x 2mm (H) (AC4217 Lot No 639098F-5) Dade Bethring Syva Emit 2000 Phenobarbital Assay, 4D019UL, lot SA070452 W6 SA070453 All Shelhigh medical devices SA070451 Ortho- Clinical Diagnostics VITROS Immunodiagnostics Products SA070454 HBsAg Reagent Pack (Cat# 6801322) SA070455 Roche CoaguChek Brand PT Test Strips SA070456 Roche COBAS Integra DIG, Digoxin Reagent (Cat# 20737836322) SA070457 Roche AmpliChip CYP450 Test-US IVD-M/N:4591402190 & CYP 450 Test, CE-IVD, M/N4381866190 AMS DURA-II Distal Tips and Universal Tips (Product no 72009340 and 72009361)
Boston Scientific(HK) Ltd MHRA MHRA LifeScan United Kingdom and Ireland MHRA MHRA FDA FDA FDA FDA FDA FDA FDA FDA FDA MHRA MHRA MHRA MHRA Health Canada Health Canada Health Canada Health Canada MHRA MHRA Boston Scientific(HK) Ltd Varian Medical Systems Pacific Inc. MHRA FDA FDA FDA FDA
N/A 2007/033/019/291/006 2007/004/002/601/745 N/A 2007/004/011/291/009 2007/002/008/601/580
Firm Initiated Field Action FSCA FSCA N/A FSCA FSCA
2007/04/16 2007/04/16 2007/04/16 2007/04/17 2007/04/18 2007/04/18 2007/04/18
Boston Scientific (HK) Ltd Science International Corp Abbott Laboratories Ltd. Johnson & Johnson Medical Hong Kong N/A N/A N/A Healthcare Diagnositcs Roche Diagnostics (Hong Kong) Limited Roche Diagnostics (Hong Kong) Limited Roche Diagnostics (Hong Kong) Limited Bio-Rad Pacific Ltd. N/A N/A Coloplast (Hong Kong) Ltd N/A N/A N/A CONMED LTD GE Medical Systems Hong Kong Ltd. Alcon Hong Kong Ltd Medtronic International, Ltd. Abbott Laboratories Ltd. N/A Boston Scientific (HK) Ltd Varian Medical Systems Pacific Inc. Abbott Laboratories Ltd. N/A N/A N/A Siemens Ltd.
2960 7128 2543 7442 2806 4201 2738 2818 N/A N/A N/A N/A 2485 7510 2485 7510 2485 7510 2789 3300 N/A N/A 3628 7488 N/A N/A N/A 2854 4413 2783 1838 2568 0636 2919 1362 2806 4201 N/A 2960 7128 2724 2836 2806 4201 N/A N/A N/A 2810 7533
Z-0747-2007 Z-0737-2007 Z-0736-2007 Z-0734-2007 to Z-0735-2007 Z-0733-2007 Z-702-2007 to Z-703-2007 Z-0727-2007 Z-0710-2007 2007/004/003/601/746 2007/004/010/131/012 2007/004/010/131/006 2007/004/013/051/003 34613 33213 34303 34068 2007/004/012/601/784 2007/003/016/081/007 N/A N/A 2007/004/017/601/800 Z-0767-2007 Z-0761-2007 Z-0752-2007 to Z-0754-2007 Z-0749-2007 to Z-0751-2007
Class II Class II Class II Class II Class II Class II Class II Class II FSCA FSCA FSCA FSCA Type II Type II Type II Type II FSCA FSCA Firm Initiated Field Action Firm Initiated Field Action FSCA Class II Class II Class II Class II
2007/04/19 2007/04/19 2007/04/19 2007/04/19 2007/04/19 2007/04/19 2007/04/19 2007/04/19 2007/04/20 2007/04/20 2007/04/20 2007/04/20 2007/04/23 2007/04/23 2007/04/23 2007/04/23 2007/04/23 2007/04/23 2007/04/23 2007/04/23 2007/04/24 2007/04/27 2007/04/27 2007/04/27 2007/04/27
SA070458 Bio-Rad tox/See Drug Screen Test SA070459
SA070460 Joerns Healthcare Sunrise Medical-Hoyer Advance Patient Lifts SA070461 Coloplast Sea-Clens Wound Cleanser (#11701-159-36, #1063) Dade Bethring Microgenics MAS Controls Cardiolmmune XL SA070462 Control (CAI-XL1. CAI-XL2, CAI-XL3, CAI-XL4) Mckinley Medical MicroSet NDEHP with 1.2 flter and SR segment SA070463 (Product code 120-112XSFV) AngioDynamics Starburst 25cm, Starburst XL 25cm and Starburst SA070464 SemiFlex 25cm SA070465 ev3 SilverSpeed .010" Guidewire (Ref:103-0601-200) SA070466 Teleflex Medical Infant Nasal CPAP System SA070467 GE Healthcare Infinia Gamma Camera SA070468 Alcon LADAR6000TM Excimer Laser SA070469 Medtronic U-Clip -Removal Tool Abbott ARCHITECT i2000 and i2000 SR Systems (list no. 8C89-01 SA070470 and 3M74-01) and Folate Reagents (List no. 7K60-20, 7K60-25, Unomedical Drain-Fix 680M and 685M, Central Gard 667M and SA070471 668M , Epi-Fix 670M SA070472 Boston Scientific SypGlassT Light Source SA070473 SA070474 SA070475 SA070476 SA070477 Varian OBI with cone beam computed tomography (Versions 1.2 and 1.3) AxSYM Total - Hcg Reagent (List no. 7A59-21, 7A59-22, 1A0622) and Speciment Diluent (List no. 9C21-50) Miltex Stainless Steel Disposable Scalpel #22 Part No 4-422 Bio-Logic-Ceegraph/Sleepscan Netlink Traveler Model 580T2ASM2 RITA Starburst XL, Starburst, Starburst MRI SemiFlex
SA070478 Siemens Mobilett XP (Model number 1818454, 1818447, 1818363)
Medical Device Control Office
110
Department of Health The Government of HKSAR
SA070479
Sunrise Medical DeVibiss PD1000A Pulse Dose Oxygen Conserving Cylinder and 535D-X CF Continuous Flow Cylinder
FDA MHRA Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada SFDA
Z-0731-2007 to Z-0732-2007 2007/004/016/121/001 34562 34726 34838 34787 34318 34725 34587 34794 34859 34684 N/A
Class II FSCA Type I Type II Type II Type II Type II Type II Type II Type II Type II Type II N/A
2007/04/27 2007/04/27 2007/04/30 2007/04/30 2007/04/30 2007/04/30 2007/04/30 2007/04/30 2007/04/30 2007/04/30 2007/04/30 2007/04/30 2007/04/30
N/A Bio-Rad Pacific Ltd. Gambro China Ltd. Gambro China Ltd. Philips Electronics Hong Kong Ltd. Baxter Healthcare Ltd Sanko Medical Systems (H.K.) Ltd. Siemens Ltd. Maquet Hong Kong Limited Smiths Medical (S.E. Asia) Ltd. N/A N/A N/A
N/A 2789 3300 2576 2688 2576 2688 2876 7525 2807 8556 2384 0688 2810 7533 2393 9511 2317 0988 N/A N/A N/A
SA070480 BIO-RAD EVOLIS SYSTEMS SA070481 Gambro Lundia AB - Prismaflex Cont. Rental Replacement System SA070482 Gambro Cartridge Blood Tubing 003409410 SA070483 Phillips Medical Voxel Q Field Upgrade to ACQSIM Baxter Healthcare Colleague 3 Volumetric Infusion Pump, SA070484 Colleague Guardian 3 CXE Color Pump, Colleague Volumetric SA070485 Toshiba Aplio XV Ultrasound System Siemens Linear Accelerators, Digital Linear Accelerator and Oncor SA070486 Impression IMRT SA070487 Maquet HL30 Perfusion System SA070488 Smiths Medical CADD Administration Sets and CADD Prizm Administration Sets
SA070489 Dade Behring BEP2000 ADV System Release Kit 1.23.3 SA070490 Zerusa Guardian Hemostasis Valve FH100 SA070491 "" Extracorporeal circulating set
Medical Device Control Office
111
Department of Health The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - March 2007
Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. No. Description of Product Source of Information FDA FDA FDA FDA FDA MHRA BD MHRA Health Canada Health Canada Health Canada Health Canada MHRA MHRA Health Canada Bausch & Lomb (Hong Kong) Ltd. Medtronic International, Ltd. FDA FDA FDA FDA Reference No. by Source Z-0428-2007 Z-0501-2007 Z-0548-2007 to Z-0549-2007 Z-0554-2007 Z-0424-2007 to Z-0426-2007 2007/001/025/081/004 N/A 2006/09/006/401/013 34055 34196 34150 33456 2006/011/027/291/008 2007/002/014/081/006 N/A N/A N/A Z-0521-2007 Z-0582-2007 Z-0542-2007 Z-0522-2007 Alert Type by Source Class II Class II Class II Class II Class II Field Safety Corrective Action Firm Initiated Field Action Field Safety Corrective Action Type II Type II Type I Type II Field Safety Corrective Action Field Safety Corrective Action Alert to Hospital Firm Initiated Field Action Firm Initiated Field Action Class II Class II Class II Class II Date of Issue (YYYY/MM/DD) 2007/03/01 2007/03/01 2007/03/01 2007/03/01 2007/03/01 2007/03/01 2007/03/01 2007/03/02 2007/03/05 2007/03/05 2007/03/05 2007/03/05 2007/03/05 2007/03/06 2007/03/06 2007/03/06 2007/03/07 2007/03/08 2007/03/08 2007/03/08 2007/03/08 Local Agent N/A Abbott Laboratories Ltd. Siemens Ltd. N/A Arjo Far East Ltd (Hong Kong) N/A BD N/A Agfa Hong Kong Limited United Tecnica Limited N/A N/A N/A Medtronic International, Ltd. N/A Bausch & Lomb (Hong Kong) Ltd. Medronic International Ltd Stryker China Ltd BD N/A N/A Agent Contact Telephone No N/A 2806 4201 2870 7533 N/A 2508 9553 N/A 2575 8668 N/A 2555 9421 N/A N/A N/A N/A 2919 1362 N/A 2213 3176 2919 1362 2518 6988 2575 8668 N/A N/A
SA070301 Taut Intraducer Peritoneal Catheter Abbott - Imx Sirolimns Reagent Pack (Lots# 053389, 053457, SA070302 063650, 063973, 064459, 064772, 064750, 065076) SA070303 Siemens Medical Solutions- Symbia S Series SPECT & SPECT-CT SA070304 Steris Corporation - Cmax Surgical Table Model No 2182625 SA070305 Arjo - Sara Active Sling, patient Lift SA070306 Edwards Lifescience - Aquarius Haemofiltration Machine SA070307 BD - Sensi- Disc Ticarcillin (Cat# 231619; Lot# 6167435) SA070308 Kjaerulff Lift Stand Aid (art no: 400640434) SA070309 AGFA - Impax 6.X DS3000, 5.1 and 5.2MA3000 SA070310 Olympus - PK7200 Microplate System (Software) SA070311 Waverleyglen Systems Ltd - Portable Reacher 24" and 36" SA070312 Hospira - Enteral Plumset with Integral Container SA070313 Huntleigh Healthcare Contoura 880 beds SA070314 Medtronic Ltd - GATEKEEPER Reflux Repair System Model 3770GK
SA070315 Pine Medical Rotating Waist Restraint SA070316 Bausch & Lomb ReNu MultiPlus contact lens care solutions SA070317 SA070318 SA070319 SA070320 SA070321 Physio-Control LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators Stryker Tom Tessier Osseous Microtome: Plug for Bone Mill Systems (Parts 01-15400; 01-15401 & 01-15407) BD Integra 1ml Syringe with Retracting Guide Needle 1 ml 29g 1/2' (0.33 x 13mm) Re-Order No. 305282 U-100 insulin (Lot# 6073436) Hospira - LifeShield Latex-Free Primary I.V. Pump Set (List 1216301, lot 39-126-5H) Exactech Optetrak All Poly Tibial PS Component, Knee prothesis catalog # 204-11-13, serial numbers 0900529 - 0900532
Clark Biocompatible Hemoperfusion Cartridge, Sorbent: SA070322 Heparinized polymer over activated carbon, 50ml, 100ml, 175ml & 250ml (Lot # 564 - 577) SA070323 LifeSync ECG System- Disposable Leadwear Ls-222, Ls-223 (Code C6310, C6324 and C6297)
FDA FDA
Z-0550-2007 to Z-0553-2007 Z-0546-2007
Class II Class II
2007/03/08 2007/03/08
N/A N/A
N/A N/A
Medical Device Control Office
112
Department of Health The Government of HKSAR
SA070324
Preservation Uni-Compartmental Knee fixed-bearing Tibial Tray Components (size 1 - 5 )
MHRA MHRA MHRA MHRA Boston Scientific (HK) Ltd MHRA MHRA MHRA MHRA MHRA MHRA Hamilton Medical FDA FDA FDA FDA FDA
2006/011/022/081/001 2007/002/001/081/014 2006/011/023/081/011 2006/012/007/081/004 N/A 2006/012/001/291/002 2007/003/001/181/002 2007/003/008/081/001 2006/011/001/081/009 2007/003/006/081/015 MDA/2007/021 N/A Z-0578-2007 to Z-0579-2007 Z-0597-2007 Z-0577-2007 Z-0545-2007 Z-0560-2007 to Z-0564-2007
SA070325 ULTIMA TPS femoral stem and ULTIMA Metal-on Metal articulation SA070326 ConMed Frazier and Poole Suction Instruments SA070327 KaVo. Dental Ltd. - QUATTROcare Spray Cans SA070328 Umimplanted PRECISION Implantable Pulse Generators (IPGs) SA070329 Timesco Optima XL Stubby Laryngoscope Handles SA070330 Vygon Lectro Cath Plus 200 cm ext. Line (batch: 0623618A) SA070331 Vygon Lectro Cath Plus150 cm ext. Line (batch: 0624291A) SA070332 VBM Medizintechnik GmbH - 13g Jet Ventilation Catheter Ref 3002-013-1 and 30-02-913-1
Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Firm Initiated Field Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Medical Device Alert Firm Initiated Field Action Class II Class II Class II Class II Class II
2007/03/08 2007/03/08 2007/03/08 2007/03/08 2007/03/09 2007/03/09 2007/03/09 2007/03/12 2007/03/13 2007/03/14 2007/03/14 2007/03/14 2007/03/15 2007/03/15 2007/03/15 2007/03/15 2007/03/15
DePuy Inc (J&J) DePuy Inc (J&J) N/A N/A Boston Scientific (HK) Ltd N/A N/A N/A N/A Beckman Coulter Hong Kong Ltd. N/A N/A Siemens Ltd. N/A N/A Siemens Ltd. Alcon Hong Kong Ltd
2738 2894 2738 2894 N/A N/A 2960 7128 N/A N/A N/A N/A 2240 6260 N/A N/A 2870 7533 N/A N/A 2870 7533 2568 0636
SA070333 Beckman Coulter FP1000 Cell Preparation System Timesco Callisto Macintosh size 3 (adult) single-use laryngiscope SA070334 blade (part # DS.3940.150.20/21) (Affected lots: GE, GF, GG, GH, GI, GJ, GK, GL, HA) SA070335 Hamilton Medical Galileo Classic and Gold ventilators Siemens Medical Solutions AXIOM Artis MP, Angiographic x-ray SA070336 system (model number 5904466& 7555365) Kensey Nash Corp. - ThromCat Thrombectomy Catheter System 7F2.5-7.0MM 150CM (Lot#54877, 55318, 55218, 54821) EKOS EndoWave Infusion System and EKOS Lysus Infusion SA070338 System (All models with Serial no. greater than and equal to 0610XXXX-XXX) Siemens Medical Solutions Sample Management System Software SA070339 for in vitro diagnostic testing Product # 030102-03 SA070337 SA070340 Alcon Custom-Pak (Part# 10975-02; 2638-17; 4917-54; 6515-51; 11148-02)
Wright Medical Technology Gladiator Bipolar Hip Prothesis (REF: SA070341 GLBP-2241; GLBP-3650; GLBP-3651L GLBP-3652; GLBP-3653; GLBP-3654; GLBP-3655) SA070342 Abiocor AB5000 Console Circulatory Support System (Catalog no. 0015-000) Arcomedical Ltd - 3101-PN3 (FSB890) Solution Set, No Y site 3, SA070343 length tubing (batches C8237)
FDA
Z-0567-2007 to Z-0573-2007 Z-0574-2007 2007/003/007/601/661 N/A MDA/2007/023
Class II Class II Field Safety Corrective Action Firm Initiated Field Action Medical Device Alert
2007/03/15 2007/03/15 2007/03/15 2007/03/15 2007/03/16 2007/03/16
Starry Medical Technology Ltd N/A N/A Boston Scientific (HK) Ltd Boston Scientific (HK) Ltd Smith & Nephew Healthcare Ltd.
2381 0279 N/A N/A 2960 7128 2960 7128
FDA MHRA Boston Scientific (HK) Ltd MHRA MHRA
SA070344 Boston Scientific Carotid Wallstent endoprosthesis Boston Scientific Ltd: Vitality and Assure implantable cardioverter SA070345 defibrillator (ICD) families and Contak Renewal cardiac resynchronisation therapy defibrillator (CRT-D) Families SA070346 Smith & Nephew RF DENERVATION PROBE (ITEM CODE 7210271; DESCRIPTOR 10 CM, LOT# 602561)
2007/003/012/081/010
Field Safety Corrective Action
2645 8703
Medical Device Control Office
113
Department of Health The Government of HKSAR
SA070347 B. Braun Medical Ltd - MANDRIN/STYLET INTROCAN SA070348 SA070349 SA070350 SA070351 SA070352 SA070353 SA070354 SA070355 SA070356 SA070357 SA070358 SA070359 SA070360 SA070361 Abbott - AxSYM Toxo LgG (List no 9K08-20; Lot no 42249HN00, 42249HN01, 43528HN00, 43528HN01) Gyrus ACMI Tripolar Ultra Cutting Foreceps (Ref no. TRU5-32, 006689-901, 006689-903) Remel MacConkey Agar w/Sorbitol, growth medium, catalog R01556 (Lot#506069) StayFix Fixation Device (REF 680ME, REF 685ME, REF670M) Cook Triple Lumen Central Venous Catheter Tray with Cook Spectrum Glide Antimicrobial Catheter with EZ--Pass Hydrophilic Coating (Recorder no. C-UTLMY-701J-RSC-ABRM-HC-FST-A) iSight PACS version 3.5 Abbott -CELL-DYN 4000 Diluent/Sheath Reagent (List#01H73-01) Manual Drive Unit for Sarns (Terumo) Centrifugal Perfusion System (Catalog # 164268) Baxter Healthcare Corp - Clearlink Paclitaxel IV Admin Set and Interlink Paclitaxel IV Admin Set Haemodialysis Machine: Integra manufactured by Gambro DePuy ASR Taper Sleeve Adaptor 9/10 (-3) and DePuy ASR Taper Sleeve Adaptor (Code no 999800313 and 999800300) Arcomedical Infusion Ltd - 3110-J (FSB499) Burette Set (Batch H24563) Biomerieux BacT/ALERT FN Culture Bottle (Product no 259793, lot no 1015145) Maquet Cardiopulmonary AG - Product Code H7101 (Lot 218333, 221734, 223245)
MHRA MHRA FDA FDA FDA FDA FDA FDA FDA Health Canada MHRA MHRA MHRA MHRA MHRA MHRA FDA BD Boston Scientific(HK) Ltd Varian Medical Systems Pacific Inc. MHRA MHRA MHRA MHRA BD MHRA MHRA Boston Scientific (HK) Ltd
2007/003/013/081/005 2007/003/012/601/683 Z-0613-2007 to Z-0615-2007 Z-0621-2007 Z-0629-2007 Z-0637-2007 Z-0616-2007 Z-0639-2007 Z-0617-2007 34385 MDA/2007/027 2007/003/016/081/002 2007/003/015/601/689 2007/003/001/601/640 2007/002/022/291/001 2006/003/014/291/019 Z-0594-2007 N/A N/A N/A 2006/009/019/181/013 2007/001/017/291/001 2006/010/013/291/005 2007/001/016/081/010 N/A 2007/003/021/081/002 2007/003/020/601/694 N/A
Field Safety Corrective Action Field Safety Corrective Action Class II Class II Class II Class II Class II Class II Class II Class II Medical Device Alert Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Class II Firm Initiated Field Action Firm Initiated Field Action Firm Initiated Field Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Firm Initiated Field Action Field Safety Corrective Action Field Safety Corrective Action Firm Initiated Field Action
2007/03/20 2007/03/20 2007/03/21 2007/03/21 2007/03/21 2007/03/21 2007/03/21 2007/03/21 2007/03/21 2007/03/21 2007/03/21 2007/03/21 2007/03/21 2007/03/21 2007/03/21 2007/03/21 2007/03/21 2007/03/21 2007/03/22 2007/03/22 2007/03/26 2007/03/26 2007/03/26 2007/03/26 2007/03/27 2007/03/28 2007/03/28 2007/03/29
N/A Abbott Laboratories Ltd. N/A N/A N/A
N/A 2806 4201 N/A N/A N/A
(1) Cook Asia (Hong Kong) Ltd.; (2) (1) 2781 0232; (2) A.R. Burkhill & Sons (Hong Kong) Ltd. 2541 1041 Philips Electronics Hong Kong Ltd. Abbott Laboratories Ltd. Terumo China (H.K.) Ltd. Baxter Healthcare Ltd Gambro China Ltd. DePuy Inc (J&J) N/A Biomerieux (Hong Kong) Maquet Hong Kong Limited N/A N/A BD Boston Scientific (HK) Ltd Varian Medical Systems Pacific Inc. N/A Smith & Nephew Healthcare Ltd. GE Medical Systems Hong Kong Ltd. N/A BD Tyco Healthcare (HKSAR) Limited N/A Boston Scientific (HK) Ltd 2876 7525 2806 4201 2866 0811 2807 8556 2576 2688 2738 2894 N/A 2356 7033 2393 9511 N/A N/A 2575 8668 2960 7128 2724 2836 N/A 2645 8703 2783 1838 N/A 2575 8668 3157 7244 N/A 2960 7128
SA070362 Karma Mobility - Martin (KM-8520 series) SA070363 Clearview Simplify D- Dimer( Kit lot no. PX018A, Batch no 682-024) BD human IL-15 recombinant protein (Mat. No. 554630) and SA070364 recombinant soluble dimeric human HLA-A2:Ig (Mat. No. 551263) SA070365 Boston Scientific Expo Selective Angiographic Catheter SA070366 Varian FastPlan treatment planning system for stereotactic radiosurgery (versions 5.1 and below)
SA070367 Medicare Technology 716 Wheelchair Lap Belt Smith & Nephew InterTan Subtrochanteric Lag Screw Driver SA070368 (Product Code: 71674068) SA070369 GE Healthcare OEC 9800 Zeiss Reusable Sensor 2PS20 or EPS01 used with Pentasys SA070370 Phacoemulsificator BD Vacutainer Safety-Lock Blood Collection Set with Pre-Attached SA070371 Holders SA070372 Puritan Bennett 840 Ventilator System Arcomedical Ltd - 3101-PN3 (FSB890) Solution Set, No Y site 3, SA070373 length tubing (batches C8218) Boston Scientific Polarcath Peripheral Dilatation System Inflation SA070374 Unit
Medical Device Control Office
114
Department of Health The Government of HKSAR
SA070375 Viasys VELA Ventilator SA070376 BioMerieux BacT/ALERT FA Culture Bottles BioMerieux BacT/VIEW C.30 a Software update (P/N 514515-1) SA070377 diagnostic data management system SA070378 Gebauer - Salivart Oral Moisturizer SA070379 Immucor Gamma Capture-R Select plates SA070380 CPS Direct SL slittable outer guide catheter SA070381 Arcomedical Ltd - 3101PNOY (FSB542) (Batch number C7944) SA070382 HoMedics Thera-P Heating Pads
FDA FDA FDA FDA MHRA MHRA MHRA FDA
Z-0638-2007 Z-0643-2007 Z-0644-2007 Z-0497-2007
Class II Class II Class II
2007/03/29 2007/03/29 2007/03/29 2007/03/29 2007/03/29 2007/03/29 2007/03/30 2007/03/30
Viasys Healthcare Hong Kong Ltd Biomerieux (Hong Kong) Biomerieux (Hong Kong) N/A N/A N/A N/A N/A
2893 0873 2356 7033 2356 7033 N/A N/A N/A N/A N/A
Class II Field Safety Corrective 2007/001/002/291/001 Action Field Safety Corrective 2007/003/021/081/003 Action Field Safety Corrective 2006/009/029/401/001 Action Z-0622-2007 to Z-0626-2007 Class I
Medical Device Control Office
115
Department of Health The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - February 2007
Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. No. Description of Product Cyberonics VNS Therapy System, Model 250-'HAND HELD' programming software v6.1, v6.1.7, v7.0, v7.1.3 & 2500SA070201 'Handhelds' preprogrammed with software v6.0, v6.1, v6.1.7, v7.0, v7 1 3 Maquet - Jostra Heater Cooler Unit HCU30, System version 1.02SA070202 Low voltage machin, Article no.: 0704629 (serial no. 101006 101024) Diagnostic Chemicals Ltd. - Salicylate - SL, in vitro diagnostic, Cat. No 511-20 (Lot#29892) Source of Information FDA Reference No. by Source Z-0341-2007 to Z0342-2007 Alert Type by Source Class II Date of Issue (YYYY/MM/DD) 2007/02/01 Local Agent N/A Agent Contact Telephone No. N/A 2393 9511
FDA FDA FDA FDA FDA FDA
Z-0350-2007 Z-0361-2007 Z-0362-2007 Z-0363-2007 Z-0364-2007 Z-0365-2007
Class II Class II Class II Class II Class II Class II
2007/02/01 2007/02/01 2007/02/01 2007/02/01 2007/02/01 2007/02/01
Maquet Hong Kong Limited N/A N/A Otto Bock Hong Kong Abbott Laboratories Ltd. N/A
SA070203
N/A N/A 2598 9772 2806 4201 N/A
Suros Surgical ATEC Breast Biopsy System handpiece for use with SA070204 ATEC Breast Biopsy and Excision System, disposable, sterile, Part no. 0912-20 (Lot: 611018) SA070205 Electronic Otto Bock Compact leg prosthesis System, 3C95/3C85 Abbott - i-STAT PT/INR Cartridge prothrombin time rest in vitro SA070206 diagnostic (product list#04J50-01 & 04J50-02; catalog# 420200; Ref.: 04J50-01 24) SA070207 Terang Nusa Sterile Neolon 2G Latex-Free Powder-Free Neoprene Surgical Gloves (Item no. MDS207060)
Philips Integris Allura System angiographic- Allura 9 F/C, Allura SA070208 Mono X-Ray System, Allura FD 10 FX, Allura FD20 x-ray, FD 10/10 x-ray system and FD 20/10 x-ray system SA070209 GE Centricity PACS RA 1000 Workstation (Version 2.1.X.X. and 3.0.X.X.)
FDA FDA FDA FDA
Z-0366-2007 to Z-0371-2007 Z-0373-2007 Z-0376-2007 Z-0377-2007 N/A
Class II Class II Class II Class II Firm Initiated Field Action Field Safety Corrective Action Medical Device Alert Medical Device Alert Field Safety Corrective Action Type II Type II Type II Type II
2007/02/01 2007/02/01 2007/02/01 2007/02/01 2007/02/02 2007/02/05 2007/02/06 2007/02/07 2007/02/07 2007/02/07 2007/02/07 2007/02/07 2007/02/07
Philips Electronics Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. Bio-Rad Pacific Ltd.
2876 7525 2783 1838 2789 3300
SA070210 Bio-Rad D-10 Dual Program Calibrator Diluent SA070211 SA070212 SA070213 SA070214 SA070215 Cook Flexor DL Dual Lumen Ureteral Access Sheath with AQ Coating, sterile REF FUS-095013-DL
(1) Cook Asia (Hong Kong) Ltd. (2) (1) 2781 0232; (2) A.R. Burkhill & Sons (Hong Kong) Ltd. 2541 1041 Boston Scientific 2960 7128
SypGlassT Lightcable, SypGlassT Camera, SpyGlass T Ocular and Boston Scientific (HK) SpyGlassT Probe Ltd Heartsine Technologies Ltd - Defibrillators, Non implantable Samaritan AED Models SAM-001, SAM-002 and SAM-003 BOC Ltd - AZ size aluminium medical nitrous oxide cylinders fitted with a key operated pin index valve for use in MRI units MHRA MHRA MHRA MHRA Health Canada Health Canada Health Canada Health Canada
2006/011/006/291/015 MDA/2007/011 MDA/2007/013 2007/001/031/121/003 33352 32880 33542 33638
N/A BOC Gases, Hong Kong Oxygen & Acetylene Co Ltd (HKO) Medtronic International, Ltd. GE Medical Systems Hong Kong Ltd. Varian Medical Systems Pacific Inc. Sanko Medical System (HK) Ltd N/A Schmidt BioMed Tech (HK) Ltd
N/A 2372 2288 2919 1362 2783 1838 2724 2836 2384 0688 N/A 2620 8310
Lucas external cardiac compressor, manufactured by Jolife AB and distributed by Medtronic Ltd GE Healthcare - Computed tomography - LightSpeed VCT SA070216 Discovery VCT - LightSpeed Pro32 - LightSpeed Pro 16 LightSpeed RT16/ LightSpeed Xtra SA070217 Varian Medical - CT/MR Ring & Tandem Applicator Set SA070218 Toshiba - Aquilion m/s (Model or Catalog # TSX-101A/7) SA070219 Walter Lorenz- 2" QC Solid Shaft Extention Spacelabs Medical - Ultraview SL Command Module SA070220 (Model/Catalog#91496)
Medical Device Control Office
116
Department of Health The Government of HKSAR
SA070221 GE Healthcare - Innova 2100 IQ SA070222 Fisher and Paykel Healthcare - Infant Evaqua Breathing Circuits SA070223 Tyco Healthcare- CT9000 ADV with Console Biomerieux - Vironostika HIV-1 Microelisa System SA070224 (Model/Catalog#259605; Lot/Serial#160354) SA070225 Misys Healthcare System Version 6.1 and 6.2 VISX Incorporated - Wavescan Wavefront System (Model/Catalog SA070226 HS-1) Dentalez Inc. Stardental Division - Solara Replacement Turbine SA070227 (Model/Catalog#263739, Lot#170510) SA070228 Siemens AG - Magneton Trio (Model: 7387074) SA070229 SA070230 SA070231 SA070232 Toshiba - Digital Fluorography System (Model or Catalog # DFP8000D) Terumo Advance Perfusion System 1 Integrated Centrifugal System Control Unit (Catalog#801046) Bard Peripheral Vascular Inc - G2 Filter System Jugular/Subclavian Delivery kit (Catalog# RF-320J & RF-220J) Davol Salute Fixation System 38cm and 18cm Resusable Shaft with Handle (Ref#113036/9113036 and 0113037/9113037)
Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada FDA FDA FDA FDA FDA
33717 33803 33834 33570 32993 33201 33350 33837 33121 Z-0381-2007 Z-0393-2007 to Z-0394-2007 Z-0374-2007 to Z-0375-2007 Z-0397-2007 N/A
Type II Type II Type II Type I Type II Type II Type II Type II Type II Class II Class II Class II Class II Press Release Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Medical Device Alert Medical Device Alert Field Safety Corrective Action Class II Class II Class II
2007/02/07 2007/02/07 2007/02/07 2007/02/07 2007/02/07 2007/02/07 2007/02/07 2007/02/07 2007/02/07 2007/02/08 2007/02/08 2007/02/08 2007/02/08 2007/02/08
GE Medical Systems Hong Kong Ltd. Tokibo Co. (Hong Kong) Ltd Tyco Healthcare (HKSAR) Limited Biomerieux (Hong Kong) N/A VISX Incorporated (HK) N/A Siemens Ltd. Sanko Medical System (HK) Ltd Terumo China (H.K.) Ltd. N/A N/A N/A N/A
2783 1838 2418 9698 3157 7244 2356 7033 N/A N/A N/A 2870 7533 2384 0688 2866 0811 N/A N/A N/A N/A
SA070233 Rhytec, Inc - Portrait PSR3 System Custom Ultrasonics Inc - Stop manufacturing and distributing SA070234 System 83 Plus Water/Disinfector and System Plus 83 Mini-Flex Washer/Disinfector SA070235 SA070236 SA070237 SA070238 SA070239 SA070240 Baxter Healthcare - Amicus Apheresis Kits F4R2337 (Lot#A06129053)
MHRA
2007/002/005/291/011 Firm Initiated Field Action 2007/002/006/291/007 2007/002/005/081/014 2007/001/015/081/013 MDA/2007/015 MDA/2007/016 2007/002/001/081/008 Z-0415-2007 to Z-0416-2007 Z-0399-2007 to Z-0400-2007 Z-0418-2007 to Z-0420-2007
2007/02/08 2007/02/09 2007/02/12 2007/02/12 2007/02/12 2007/02/13 2007/02/13 2007/02/14 2007/02/15 2007/02/15 2007/02/15
Baxter Healthcare Ltd Boston Scientific (HK) Ltd Medtronic International Ltd Abbott Laboratories Ltd. Bayer Healthcare Ltd (Hong Kong) Smiths Medical (S.E. Asia) Ltd. Direct Health Ltd Medtronic International Ltd Abbott Laboratories Ltd. Stryker China Ltd Beckman Coulter Hong Kong Ltd
2807 8556 2960 7128 2919 1362 2806 4201 2814 4829 2317 0988 2528 1109 2919 1362 2806 4201 2518 6988 2240 6260
Boston Scientific - Urgent Medical Device Recall - Immediate Action Boston Scientific (HK) Required: Matrix 2 Ltd Medtronic - Spinal Implants - Colorado 2 Anterior Plates # 8639500 & #8619500 Abbott - StarClose Vascular Closure System (Catalogue# 14677; Lot # 43034-6H to 47139-6H) Bayer - Benzodiazepine Reagent Lot 56510483 used with ADVIA 1200, 1650, 1800 and 2400 Chemistry System Smiths Medical Level 1 normothermic IV Fluid administration set (Catalogue # DI-60HL) (NHS Supply Chain code FFF265) MHRA MHRA MHRA MHRA MHRA MHRA FDA FDA FDA
SA070241 Invacare C800 Series ceiling track SA070242 Medtronic - Vitatron T and C pacemakers Abbott - ARCHITECT i2000 Processing Module (List#08C89-01 & SA070243 3M74-01; Temp Controller Board Par#78560-109&7856-109) Stryker - Triathlon X3 CR Tibial Bearing Insert for Knee prosthesis SA070244 size # 2-11MM & 7-11MM (Ref# 5530-G-211 2011-09 & 5330-G711 2011-09) Cytomics FC500 and FC500 MPL with CXP Software version 2.0 & SA070245 2.1
Medical Device Control Office
117
Department of Health The Government of HKSAR
SA070246
Perry-Kolberg Tiatanium Motility/Support System (Model 100045) (Lot# M-50021)
FDA MHRA MHRA MHRA MHRA FDA FDA Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada
Z-0396-2007 MDA/2007/017 MDA/2007/018 2007/002/008/601/579 2007/002/005/081/012 Z-0414-2007 Z-0398-2007 33376 33986 33633 33908 33815 33905 33634 33902 33870
Class II Medical Device Alert Medical Device Alert Field Safety Corrective Action Field Safety Corrective Action Class II Class II Type II Type II Type II Type II Type II Type II Type II Type II Type II
2007/02/15 2007/02/15 2007/02/15 2007/02/15 2007/02/15 2007/02/15 2007/02/15 2007/02/21 2007/02/21 2007/02/21 2007/02/21 2007/02/21 2007/02/21 2007/02/21 2007/02/21 2007/02/21
N/A Welch Allyn Draeger Medical Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. N/A N/A N/A Tokibo Co. (Hong Kong) Ltd. N/A Smith Medical (S.E. Asia) Ltd. Adaltis Healthcare (HK) Ltd Philips Electronics Hong Kong Ltd. N/A N/A N/A N/A
N/A N/A 2877 3077 2783 1838 N/A N/A N/A 2418 9698 N/A 23170988 3123 8000 2876 7525 N/A N/A N/A N/A
SA070247 Welch Allyn PIC50 External Defibrillator/ Monitor SA070248 Draeger Infinity monitor with Infinity docking station(IDS) SA070249 GE Healthcare - Ventilator - Engstom Ventilator SA070250 Thoratec Corporation - thoratec VAD Dual Drive Console SA070251 SA070252 Ascent Healthcare Solutions - AutoSuture Bladed Trocar (Model # 179094) Belcher Pharmaceuticals Inc - Mucotrol Conc. Oral Gel Wafer contained in HDPE Bottle
SA070253 Fisher and Paykel Healthcare - Cosycot Infant Warmer SA070254 Wilson-Cook Medical, Inc. - Quantum Biliary Dilation Balloon SA070255 Medex Inc. - Pressure Transducer Cartridge SA070256 Adaltis Inc. - Detect-HCV V.3 (Model/Catalog# HCA-702B; Lot/Serial# 6770192, 6770192F)
SA070257 Philips Medical System - Brilliance CT Big Bore System, Main Unit Resonant Medical Inc. - Restitu U/S Guide & Restitu U/S-SIM SA070258 (Model# 9100-00015-2 & 9100-00015-1) SA070259 Linvatec - E9000 Bur Products and Ultrapower Bur Products SA070260 Skytron - Infinity Series Surgical Lights Cardinal Health - Custom Sterile Cardiovascular Packs SA070261 (Model/Catalog#SCV30OHXXX, SCV30PCXXX) (Lot/Serial#769528, 781014, 778976, 787188) SA070262 GE Healthcare - Precision RX/I Fluoroscopic X-Ray System (Model/Catalog#S1303JJ/JK/JL/JM)
Health Canada Health Canada Health Canada MHRA MHRA
32633 32382 33595 2007/002/014/401/013 2007/002/015/081/004
Type II Type II Type II Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action
2007/02/21 2007/02/21 2007/02/21 2007/02/21 2007/02/21
GE Medical Systems Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. Johnson & Johnson Medical Hong Kong N/A Cemma Enterprise Co Ltd
2783 1838 2783 1838 2738 6162 N/A 2412 2310
GE Healthcare - Precision 500D (Model/Catalog#S0915KE, SA070263 S0915KF) Ortho- Clinical Diagnostics - Fetalscreen Test for D(RHO) Positive SA070264 Fetal Red Blood Cells (Model/Catalog#780540) (Recall#33595) Williams Medical Suppliers Plc - Comfisound (Code: D52208, SA070265 D52209, 69.2100) American medical System- AMS700 Penile Prosthesis (Part no: SA070266 72402987; Lot 475485004) Smith&Nephew - Peri-Loc Lateral- Proximal Locking Plate, Right SA070267 (Product codes: 71800508 & 71800513) (Lots# 06CM17723 & 06CN15086) Candela - Vbeam/Aesthetica, Platiunum and Perfecta model laser SA070268 systems SA070269 Cardinal Health - Alaris Div -Syringe pumps (Signature Edition)
MHRA
2007/001/016/081/012
2007/02/21
Smith & Nephew Healthcare Ltd. 2645 8730
MHRA MHRA
2007/001/029/081/010 2006/008/029/081/009
2007/02/21 2007/02/21
N/A N/A
N/A N/A
Medical Device Control Office
118
Department of Health The Government of HKSAR
Conmed DetachaTip endoscopic Multiple use grasper and SA070270 disposable hand held graspers and dissectors (Ratcheted and nonratcheted) SA070271 Durex Canada - Confirm Clearly Smart Pregnancy Test SA070272 SonoSite Inc (UK Rep) - LAP/12-5MHz Laparoscopic Transducer SA070273 Makro Medical - MAKROMED URINE TEST STRIPS - all models SA070274 SA070275 SA070276 Clearview Simplify D- Dimer( Product code 505285; Kit Lot numbers: PT030A & PT031A) Abbott - ARCHITECT FREE T3 Reagent (List # 7K63-20, 7K63-25, 7K63-30) Intavent Orthofix Ltd - Flexible size 2.5 Laryngeal Masks (REF 7125R and 7125DR)
MHRA Health Canada MHRA MHRA MHRA MHRA MHRA MHRA
MDA/2007/019 34026 2007/002/020/291/011 2007/001/023/081/007 2007/002/020/291/014 2007/002/019/601/608 2007/002/013/081/009 2007/002/019/121/006
Medical Device Alert Type II Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action
2007/02/21 2007/02/21 2007/02/21 2007/02/22 2007/02/26 2007/02/26 2007/02/27 2007/02/27
N/A SSL Healthcare Asia Ltd N/A N/A N/A Abbott Laboratories Ltd. N/A N/A
N/A 2528 6778 N/A N/A N/A 2806 4201 N/A N/A
Bausch & Lomb - TSV 25 Gauge High-Speed Cutter (Catalog no SA070277 CX5825) & TSV 25 Gauge High-Speed Posterior Vitectomy Pack (Catalog nos CX4925 & CX4925A)
Medical Device Control Office
119
Department of Health The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - January 2007
Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. No. SA070101 SA070102 SA070103 SA070104 Description of Product Terumo Advanced Perfusion System 1, Model 801763; Model 801764 Endologix Infrarenal Bifurcated Powerlink System with Visifiex Delivery System (endovascular graft). Model No, 25-16-155BL Solara Replacement Turbine, Autochuck End Cap, for dental handpiece, part no, 064900 Terumo Advanced Perfusion System 1, Model 801763; Model 801764 Source of Information FDA FDA FDA FDA Reference No. by Source Z-0306-2007 & Z-307-2007 Z-0309-2007 & Z-310-2007 Z-0313-2007 Z-0314-2007 & Z-0315-2007 Alert Type by Source Class II Class II Class II Class II Date of Issue (YYYY/MM/DD) 2007/01/03 2007/01/03 2007/01/03 2007/01/03 Local Agent Terumo China (H.K.) Ltd. N/A N/A Agent Contact Telephone No. 2866 0811 N/A N/A
Terumo China (H.K.) Ltd.
2866 0811
Posterior Acetabular Retractor-Left with Light Cord Bracket, Model #BIO-1-1050-A, Posterior Acetabular Retrator-Right with Light Cord SA070105 Bracket, Model #BIO-1-1050-A, packaged 1 retractor (left or right retractor) per plastic bag SA070106 Sorin Group Venous Femoral Catheter Wire Reinforced Siemens Medical Solutions Mammomat 1000 and Mammomat SA070107 3000/Nova SA070108 GE Healthcare Technologies (Prev Datex Ohmeda) Aisys SA070109 Siemens AG Magicsas/Sienet IWM Smiths Medical ASD Inc. Bivona Laryngectomy Tube, Long (Lot SA070110 1263830) SA070111 LifeScan One Touch Ultra/Basic/Profile Blood Glucose Test Strips SA070112 SA070113 SA070114 SA070115 Bard Composix Kugel Large Sized Patches Terumo Advanced Perfusion System 1, Model 801041; Model Philips Medical Systems HeatStart FR2+ Defibrillator, Terumo Advanced Perfusion System 1 Edwards LifeSciences-Swan-Ganz, Thermodilution Venous Infusion SA070116 Port(VIP) Catheter with AMC Throboshield (An Antimicrobial Heparin Coating), Ref: 831HF75, Model 831FH75 SA070117 Smiths Medical ASD Inc. Bivona Laryngectomy Tube, ID 8.5mm, O.D. 11mm Length 88mm, TTS 11.8mm
FDA
Z-0316-2007
Class II Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Type II Type II Class I Class I Class II Class II Class II Class II Class II
2007/01/03
N/A
N/A
MHRA MHRA MHRA Health Canada Health Canada FDA FDA FDA FDA FDA FDA FDA
2006/012/012/081/008 2007/001/003/081/001 2006/010/023/601/367 33372 33320 Z-0266-2007 Z-0292-2007 & Z-0293-2007 Z-0308-2007 Z-0322-2007 & Z-0337-2007 Z-0338-2007 Z-0339-2007
2007/01/04 2007/01/04 2007/01/04 2007/01/08 2007/01/08 2007/01/10 2007/01/10 2007/01/10 2007/01/10 2007/01/10 2007/01/10 2007/01/10
N/A Siemens Ltd. GE Medical Systems Hong Kong Ltd. Siemens Ltd. Smiths Medical (S.E. Asia) Ltd. Johnson & Johnson Medical Hong Kong Terumo China (H.K.) Ltd. Philips Electronics Hong Kong Ltd. Terumo China (H.K.) Ltd. N/A Smiths Medical (S.E. Asia) Ltd.
N/A 2870 7533 2783 1838 2870 7533 2317 0988 2738 6080 2866 0811 2876 7525 2866 0811 N/A 2317 0988
Smith & Nephew Trufit CB Plug Size Codes: Red, 7mm (Part #605SA070118 001-03, Blue, 9mm (Part #605-001-05); TruFit BGS Plug Size Code Red, 7mm (Part #600-001-03), Blue 9mm (Part#600-001-05) Puritan Bennett KngithStar 330 Bi-Level Ventilator, Catalogue No. SA070119 Y-KS330-NA. Y-KS330-SD, DSY-KS330-NA, DSY-K5330-SD, DLYKS330-NA & DLY-KS330-SD SA070120 SA070121 Bayer Advia 70 Hematology Analyzer, Drew Excell 22 Hematology Analyzer Abbott Laboratories, Inc. Phenobarbital-Reagent-Clinical Chemistry, List no. 1E08-20
FDA
Z-0440-2007 to Z-0443-2007
Class II
2007/01/10
Smith & Nephew Healthcare Ltd. 2645 8703
FDA
Z-044-2007
Class II
2007/01/10
Tyco Healthcare (HKSAR) Limited
3157 7244
FDA FDA
Z-0448-2007 & Z-0449-2007 Z-0454-2007
Class II Class II
2007/01/10 2007/01/10
Bayer Healthcare Ltd. (Hong Kong) Abbott Laboratories Ltd.
2814 4829 2806 4201
Medical Device Control Office
120
Department of Health The Government of HKSAR
SA070122 SA070123
Integra LifeSciences BOLD/INI-CLIP 2.2mm Drill Bit with AO Attachment. Model/Catalog No. 159004ND Shenzhen Bestman Instrument Media Injectors (X-ray) contrast medium syringe
FDA MHRA MHRA
Z-0466-2007 2006/011/022/401/015 2006/010/002/601/324
Class II Field Safety Corrective Action Field Safety Corrective Action
2007/01/10 2007/01/10 2007/01/10
N/A N/A N/A
N/A N/A N/A
SA070124 Corybros Ltd - CB3600 Select lots of O2Optix (lotrafilcon B) Soft Contact Lenses. The lots affected in this recall are all lots numbers starting with 6644001 to 6721262 with expiration dates starting from 2011/09 to 2011/11, SA070125 and lot numbers 6626127, 6636101, 6637017, 6637019, 6637103, 6640120, 6640124, 6642109, 6642119, and 6643080, all with expiration dating of 2011/08. SA070126 Stryker - Howmedica Hip Fracture Stem System SA070127 SPS Blue Line Tube Clamp Adapters, Product number BL120M Viasys V.P.I. Bird Gold pediatric ventilator, catalog no. 15653 and SA070128 15654 Arjo - BHM Reacher for Portable Ceiling Lifts (Model: Part SA070129 #700.08310-24' and Part #700.08320-36') Ossur - Re-Flex VSP and Low Profile Re-Flex VSP external SA070130 prosthetic foot modules (Model no.: RFXS0002, RFXS0003, RFLS0006 and RFL50007 SA070131 Stryker - Simplex P with Tobramycin Anitibiotic PMMA Bone SA070132 Varian Medical Systems GammaMed 12i and 12t radionuclide applicator systems
Health Canada
33715
Type II
2007/01/16
CIBA Vision (Hong Kong) Ltd.
2814 2121
FDA FDA FDA FDA FDA FDA FDA FDA Medtronic International, Ltd. Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada
Z-0472-2007 to Z-0476-2007 Z-0445-2007 Z-0480-2007 to Z-0481-2007 Z-0482-2007 Z-0486-2007 Z-0467-2007 Z-0486-2007 to Z-0487-2007 Z-0483-2007 to Z-0484-2007
Class II Class II Class II Class II Class II Class II Class II Class II
2007/01/17 2007/01/17 2007/01/17 2007/01/17 2007/01/17 2007/01/17 2007/01/17 2007/01/17
STRYKER CHINA LTD N/A Viasys Healthcare Hong Kong Ltd Arjo Far East Ltd (Hong Kong) Socofar Ltd STRYKER CHINA LTD N/A Baxter Healthcare Ltd
2518 6988 N/A
2508 9553 2861 3261 2518 6988 N/A 2807 8517
Baxter Colleague Single and Triple Channel Volumetric Infusion SA070133 Pumps (Product codes: 2M8151, 2M8151R, 2M8161, 2M8161R, 2M8153, 2M8153R, 2M8163, 2M8163R) Medtronic - Voluntary Field Corrective Action of Reliant Stent Graft SA070134 Balloon Catheter and Talent Coiltrac AAA Stent Graft Delivery System with Balloon. SA070135 Toshiba - Xario Main Unit (Model # SSA-660A) Toshiba - Digital Fluorography System (Model or Catalog # DFPSA070136 8000D) SA070137 Toshiba - Aquilion m/s (Model or Catalog # TSX-101A/DC and TSX-101A/8)
N/A 32878 and 33122 33123 32870 33118 32452 32607 33501 32189 33251 33587 33400
N/A Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II
2007/01/22 2007/01/22 2007/01/22 2007/01/22 2007/01/22 2007/01/22 2007/01/22 2007/01/22 2007/01/22 2007/01/22 2007/01/22 2007/01/22
Medtronic International, Ltd. Sanko Medical System (HK) Ltd Sanko Medical System (HK) Ltd Sanko Medical System (HK) Ltd Sanko Medical System (HK) Ltd Nordep Healthtech Nordep Healthtech Philips Electronics Hong Kong Ltd. Johnson & Johnson Medical Hong
JOINHANDS TECH LTD
2919 1362 2384 0688 2384 0688 2384 0688 2384 0688 2881 7871 2881 7871 2876 7525 2738 2818 2635 3455 2877 3077 N/A
SA070138 Toshiba - X-Rays High Voltage Generator Inverness Medical Professional Diagnostics - Clearview HCG SA070139 Combo (Model or Catalog # 6026KCV) SA070140 SA070141 Inverness Medical Professional Diagnostics - Clearview HCG Combo (Model or Catalog # 6026KCV) Philips Medical System- Allura XPER FD10 and Allura XPER FD20/10 System, Main Unit
SA070142 Cordis Prowler Infusion Catheter SA070143 Baylis Medical Company, Inc. - Baylis RF Cannula Draeger Medical - Medical Air Compressor (Model or SA070144 Catalog#8413419) SA070145 Alsius Corp. - Cool Line Catheter Model CL-2295AE
Draeger Medical Hong Kong Ltd. N/A
Medical Device Control Office
121
Department of Health The Government of HKSAR
SA070146
Roche Diagnostics GMBH - Tina-Quant Gen 2 Albumin (ALBT2) R2 and Immunoglobulin G (IGGT) Assay
Health Canada Health Canada Health Canada Health Canada MHRA Health Canada MHRA MHRA MHRA FDA FDA FDA FDA
32922 33046 33058 33211 2006/012/021/601/481 33497 MDA/2007/007 2006/004/027/121/008 2007/001/008/081/007 Z-0351-2007 to Z-0353-2007 Z-0354-2007 to Z-0355-2007 Z-0455-2007 Z-0319-2007 to Z-0321-2007
Type II Type II Type I Type I Field Safety Corrective Action Type II Medical Device Alert Field Safety Corrective Action Field Safety Corrective Action Class II Class II Class II Class II
2007/01/22 2007/01/22 2007/01/22 2007/01/22 2007/01/22 2007/01/22 2007/01/25 2007/01/25 2007/01/25 2007/01/25 2007/01/25 2007/01/25 2007/01/25
Roche Diagnostics (Hong Kong) Limited GE Medical Systems Hong Kong Ltd. N/A N/A GE Medical Systems Hong Kong Ltd. N/A BOC Gases, Hong Kong Oxygen & Acetylene Co Ltd (HKO) Beckman Coulter Hong Kong Ltd. Varian Medical Systems Pacific Inc. Bayer Healthcare Ltd. (Hong Kong) Abbott Laboratories Ltd. N/A N/A
2485 7510 2783 1838 N/A N/A 2783 1838 N/A 2372 2288 2240 6260 2724 2836 2814 4829 2806 4841 N/A N/A
SA070147 GE Healthcare - Advantx LCN, Advantx LCLP and Innova 4100 I-Flow Corp. - ON-Q Painbuster, 100ml x 2ml/hr (Model or SA070148 Catalog#PM012 )(Lot or Serial # 662449, 662742) SA070149 Airox Legendair Ventilator (Lot or Serial# All Airox Legendair Ventilator LE030007, EXPECT LE020007, LE021009)
SA070150 GE Healthcare -Apex Pro/ApexPro CH Telemetry System Interventional Technologies Europe Ltd. - 1 cm Peripheral Cutting SA070151 Balloon SA070152 SA070153 BOC Ltd - AZ size aluminium medical oxygen cylinders fitted with a key operated pin index valve for use in MRI units Beckman Coulter - Access Immunoassay System CEA (Part no 33200) (Lot no.: ALL)
SA070154 Varian Medical - On Board Imager CBCT Bayer Healthcare ADVIA 1650, 1200 and 2400 Chemistry Systems, SA070155 Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests SA070156 Abbott Spine TraXis Fixed Trail and TraXis Fixed Rasp SA070157 Embeem Inc - HiZel, Trayless-sterile hydrogel wound dressing Rymed Technologies, Inc. - RYM-5000 & RYM-5001 InVision-Plus SA070158 Neutral Displacement and RYM-5000 InVision-Plus NEUTRAL I.V. Connector Continental Medical Labs, Inc. -Fibrin Analysis Catheter Testing SA070159 System includes the component BD Vacutainer Luer-Lok Access Device (Catalog#364902) SA070160 Boston Scientific - HTA System SA070161 Draeger Medical - Neonatal radiant warmer: Draeger Resuscitaire model RW82VHA-1C with variable height adjustment
FDA Boston Scientific (HK) Ltd MHRA
Z-0357-2007 N/A MDA/2007/2008
Class II Firm Initiated Field Action Medical Device Alert Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action
2007/01/25 2007/01/26 2007/01/30
N/A Boston Scientific (HK) Ltd N/A
N/A 2960 7128 N/A
Unomedical Ltd - Cord Clamps: Cutter-umbilical cord clamp clipper SA070162 (lot#102042/118351/121457/134481/136591/142538/146675/15116 8/155746) SA070163 SA070164 Hemo Cue Ltd - HemoCue Glucose 201 and HemoCue Glucose 201RT instruments Siemens Diagnostics - IMMULITE 2000/2005 Chartable Report Used with SMS
MHRA
2006/007/027/401/003
2007/01/30
N/A
N/A
MHRA MHRA
2007/001/015/081/014 2007/001/023/601/530
2007/01/30 2007/01/31
Science International Corp Siemens Ltd.
2543 7442 2870 7533
Medical Device Control Office
122
Department of Health The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - December 2006
Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. No. Description of Product Source of Information Reference No. by Source Alert Type by Source Date of Issue (YYYY/MM/DD) BD Pharmingen No Azide/Low Endotoxin Mouse Anti-Human CD16 SA061201 Becton Dickinson Asia Ltd. Firm Initiated Field Action 2006/12/04 Monoclonal Antibody, Clone 3G8, Cat. No. 555403, lot # 43033 BD Pharmingen PE-Conjugated Mouse Anti-Human Fetal Hemoglobin SA061202 Becton Dickinson Asia Ltd. Firm Initiated Field Action 2006/12/04 Monoclonal Antibody, Clone 2D12, Cat. No. 551797, lot # 38377 SA061203 SA061204 SA061205 SA061206 SA061207 SA061208 SA061209 SA061210 SA061211 SA061212 SA061213 SA061214 SA061215 SA061216 SA061217 SA061218 SA061219 SA061220 SA061221 SA061222 SA061223 SA061224 SA061225 SA061226 SA061227 SA061228 SA061229 SA061230 SA061231 SA061232 SA061233 SA061234 SA061235 SA061236 SA061237 SA061238 SA061239 SA061240 Baxter Health Flo-Gard 6200, 6201, 6300 & 6301 Depuy Int. (J&J) Preservation Uni-Compartmental Knee size 3 Fixed bearing Tibial Tray Boston Scientific iLab Ultrasound Imaging System, Installed Models iLab120INS and iLab240INS Lone Star Medical Products 1100 Series Aluminum Retractor Rings, Models #1104, 1107 and 1110 Nihon Kohden Electric Stimulator, Model number: MS-210BK, Any serial numbers up to 02160 Computerized Medical Systems AccuSeed DS Digital Stepper, an accessory to a prostate radiation treatment planning system, Model Inverness Medical Professional Diagnostics NOW Legionella Urinary Antigen Test. 22 test kit, Product Code: 852-00, Lot Number: 024448 Data Innovations Roche Modular Drive (rchmdlri) and Roche Cobas driver (rchcob6i) analytical laboratory data interface, various software Dentsply Friadent XiVE S plus Screw Implant D3.0/L11, D3.0/L13 and D3.0/L15 dental implants Cory Brothers Ltd. MPC SCT/50/6 Suctioni Tubing Abbott Molecular Inc. RealTime CT/NG assay and RealTime CT assay List Number 2G28 and 1L31 TomoTherapy Incorporated HI-ART System H-0000, H-0000-0001 Kavo Dental Quattrocare spray can Bard Ltd. Peripheral Saxx-Stent and Saxx Premounted Peripheral Stent Implantation System Innovatek Medical Quickstick HCG Pregnancy Test Kit, Model or Catalog # 4220-4K, Lot or Serial # 5-09076 Toshiba Medical Systems Aquilion CT Scanner, Model or Catalog # Philips Brilliance CT Big Bore System, Lot or Serial # 7062 and 7017 MHRA MHRA Boston Scientific H. K. Ltd. FDA FDA FDA FDA FDA FDA MHRA MHRA MHRA MHRA MHRA Health Canada Health Canada Health Canada 2006/011/030/291/010 2006/011/022/081/001 FSCA FSCA Firm Initiated Field Action Z-0212-2007 to Z-0214-2007 Class II Z-0218-2007 Z-0221-2007 Z-0222-2007 Z-0223-2007 & Z-0224-2007 Class II Class II Class II Class II 2006/12/04 2006/12/04 2006/12/06 2006/12/06 2006/12/06 2006/12/06 2006/12/06 2006/12/06 2006/12/06 2006/12/06 2006/12/06 2006/12/06 2006/12/08 2006/12/08 2006/12/11 2006/12/11 2006/12/11 2006/12/11 2006/12/11 2006/12/11 2006/12/11 2006/12/11 2006/12/11 2006/12/11 2006/12/11 2006/12/11 2006/12/11 2006/12/13 2006/12/13 2006/12/13 2006/12/13 2006/12/13 2006/12/13 2006/12/13 2006/12/14 2006/12/15 2006/12/15 2006/12/18 Sanko Medical Systems (H.K.) Ltd. Bio-Rad Pacific Ltd. Medtronic International, Ltd. Abbott Laboratories Ltd. 2384 0688 2789 3300 2919 1362 2806 4841 The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed all affected users. The local agent informed all affected users. The local agent informed that no affected units had been distributed in Hong Kong. Johnson & Johnson Medical Hong Kong 2738 6080 The local agent informed that no affected units had been distributed in Hong Kong. Sanko Medical Systems (H.K.) Philips Electronics Hong Kong Ltd. Medisource Supply (Asia) Co. Ltd. Philips Electronics Hong Kong Philips Electronics Hong Kong Ltd. 2384 0688 2821 5480 2145 4442 2876 7525 2821 5480 The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. Abbott Laboratories Ltd. Interdental Ltd. 2806 4841 2541 1096 The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed all affected users. Data Innovations Asia 2398 3182 Local Agent Becton Dickinson Asia Ltd. Becton Dickinson Asia Ltd. Baxter Healthcare Ltd. Johnson & Johnson Medical Hong Kong Boston Scientific H. K. Ltd. Agent Contact Telephone No. 2575 8668 2575 8668 2807 8556 2738 2818 2960 7117 The local agent informed that no affected units had been distributed in Hong Kong. Remarks The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed all affected users. The local agent informed all affected users.
Z-0230-2007 to Z-0232-2007 Class II MDA/2006/067 2006/011/030/601/437 2006/011/015/291/006 2006/012/007/081/004 2006/012/005/601/444 Recall # 32712 Recall # 31601 Recall # 32814 Recall # 32787 Recall # 32826 Recall # 32827 Recall # 32662 Recall # 32817 Recall # 32928 Recall # 30550 Recall # 32953 Action FSCA FSCA FSCA FSCA Type II Type II Type II Type II Type II Type II Type II Firm Initiated/Type III Type II Type II Type II Firm Initiated Field Action 2006/012/007/601/454 Z-0228-2007 Z-0244-2007 Z-0247-2007 Z-0248-2007 / Z-0249-2007 2006/011/023/081/004 2006/012/013/291/005 2006/012/012/601/458 FSCA Class II Class II Class II Class II Firm Initiated Field Action FSCA FSCA FSCA Firm Initiated Field Action Firm Initiated Field Action MDA/2006/071 Action
Conmed Soft Tip Frazier, Frazier Surgical Suction Instrument and Poole Health Canada Suction Instrument Health Canada Philips Ultrasound IE33 Diagnostic Ultrasound Transducer, Identifier Philips Medical Systems Gemini GXL 6/10/16 Slice Pet/CT System, lot Health Canada or serial # 882410 Health Canada Medi-Inn Swabette, model or catalog # MIS300 and MIS401 LifeScan OneTouch Ultrasmart Blood Glucose Meter, model or catalog LifeScan Ltd. # 020-720 and 020-721 with serial numbers starting with TC, TD, TF or Health Canada Unomedical A/S Cord Clamp Clipper, Serial # M3186023572, Lot # Toshiba Medical Systems Digital Fluorography System, Model or Health Canada Catalog # DFP-8000D and DFP-8000D/FPD Bio-Rad Laboratories Diagnostics D-10 Haemoglobin Testing System Health Canada Dual Program, model or catalog # 220-0201 Medtronic Precision Plus Transurethral Needle Ablation (TUNA) therapy Medtronic International, Ltd. system, model 7900 MHRA Abbott Diagnostics Architect LH Reagent FDA Accumetrics Inc. Verify Now P2Y12 Assay Device Kit, Part No. 85054 FDA Teleflex Medical Neoprene Pecan Shaped Breathing Bag Dade Behring Brand MicroScan Prompt Inoculation System-D; Catalog FDA #B1026-10D FDA Arjo Inc. Sling Rope/Connector Asembly Kits Boston Scientific 1cm peripheral cutting balloon microsurgical dilatation Boston Scientific H. K. Ltd. devices MHRA Fisher and Paykel Healthcare Ltd (NZ) Acclaim HC401 Nasal Mask Fisher and Paykel Healthcare Ltd (NZ) All Single Use Heated Breathing MHRA Circuits Arcomed Administration Set-3101-LPPJ MHRA Boston Scientific H. K. Ltd. Boston Scientific Hemashield vascular grafts and fabrics Boston Scientific Katzen infusion wires William Cook Europe Flexor Check-Flo Micropuncture Radial Artery Access Introducer Sets with AQ Hydrophilic Coating Boston Scientific H. K. Ltd. MHRA
Dade Behring Hong Kong Ltd Arjo Far East Limited Boston Scientific H. K. Ltd. Tokibo Co. (Hong Kong) Ltd. Tokibo Co. (Hong Kong) Ltd. Boston Scientific H. K. Ltd. Boston Scientific H. K. Ltd.
2803 0118 2508 9553 2960 7117 2418 9698 2418 9698 2960 7117 2960 7117
The local agent informed all affected users. The local agent informed that no affected units had been distributed in Hong Kong.
Medical Device Control Office
123
Department of Health The Government of the HKSAR
SA061241 SA061242 SA061243 SA061244 SA061245 SA061246 SA061247 SA061248 SA061249 SA061250 SA061251 SA061252 SA061253 SA061254 SA061255 SA061256 SA061257 SA061258 SA061259 SA061260 SA061261 SA061262 SA061263 SA061264 SA061265 SA061266 SA061267 SA061268 SA061269 SA061270 SA061271 SA061272 SA061273 SA061274 SA061275 SA061276 SA061277 SA061278 SA061279 SA061280 SA061281
Lombard Medical - Bifurcated Endovascular Graft Aorfix II Inditherm Heating Mattress Boston Scientific Mach 1 guide catheters Medtronic Rocker Reducer instruments Biosense Webster Europe Preface Guiding Sheath Guidant Ltd. Acrobat Vacuum Stabilizer System Femcare-Nikomed Ltd. Femcare Camera Sleeve Medtronic LIFEPAK 20 Defibrillator/Monitors Smiths Medical International CADD-Legacy PLUS and CADD-Legacy 2 Ambulatory Infusion Pumps -21-6400 & 21-6500 LifeScan One Touch Ultra/Basic/Profile Blood Glucose Test Strips AMO Tecnis Acrylic Model ZA9003 Intraocular Lenses Terumo Cardiovascular Systems Terumo Perfusion System BD Vacutainer Luer-Lok Access Device Holder with Pre-Attached Multiple Sample Adapter Sterile AMO PhacoFlex II Model SI40NB Intraocular Lenses Medline Industries Medline Premium Wet Shin Prep Tray Gambro Lundia AB (Monitor Division) CWP100 Biodiagnostics Ltd. Crithidia Luciliae Slides - Catalogue no. L058 / L108 Roche Diagnostics Cobas Taqman CT test, Amplicor Chlamydia Trachomatis Detection Kit, Amplicor Chlamydia Invacare Spectra Plus Powered Wheelchair Boston Scientific Wallstent endoscopic biliary endoprosthesis with Unistep Plus delivery system B Braun Aesculap Metha Modular short Stem Prosthesis BD Mini Blade LifeScan One Touch Ultra/Basic/Profile Blood Glucose Test Strips LifeScan One Touch Ultra/Basic/Profile Blood Glucose Test Strips Medrad Invasive Blood Pressure Interface Cables (Part #3006314, 3008772 & 3010478) Guidant Contak REnewal 3 RF, 3 RF HE, 4 RF & 4 RF HE cardiac resynchronization therapy defibrillator Arrow Implantable Vascular Access System - Infusion Ports with Silicone Rubber Catheter Maillinckrodt OptiVantage DH Power Injection System Draeger Medical Infinity Docking Station (IDS) Delta and Kappa Patient Monitors. Model Nos. 4715319, 5206110 and 7489375 Datex Ohmeda Compact Absorber, Disposable REF 427002100, white to violet and REF 427002000 Terumo Advanced Perfusion System 1 Electonic Oxygen Blender/Analyzerl Catalog No. 801188 Maquet Critical Care AB HL30 Perfusion System Maquet Critical Care AB Jostra Heater-Cooler Unit 30 System Elekta Desktop Pro 6.0/6.1 Bio-Rad Laboratories Diagnostics Group Liquichek Cardiac Markers Control LT, Model 645, 645X, 646, 647, 648, 649, 649X Guidant ACS Rotating Hemostatic Valve GE OEC Medical System, DBA GE Healthcare OEC 9900 Siemens Medical Solutions Linear Accelerators Siemens AG Lithoskop Bausch & Lomb 20 Gauge High Speed Electric Vitrectomy Cutters SuperDimension Bronchus System
MHRA MHRA Boston Scientific H. K. Ltd. Medtronic International, Ltd. MHRA MHRA MHRA Medtronic International, Ltd. MHRA FDA FDA FDA FDA FDA FDA MHRA MHRA MHRA MHRA Boston Scientific H. K. Ltd. MHRA Becton Dickinson Asia Ltd. FDA FDA FDA FDA FDA FDA FDA FDA FDA Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada MHRA MHRA
2006/012/014/081/002 2006/011/024/401/010
FSCA FSCA Firm Initiated Field Action Firm Initiated Field Action
2006/12/15 2006/12/18 2006/12/19 2006/12/19 2006/12/18 2006/12/18 2006/12/19 2006/12/20 2006/12/20 2006/12/20 2006/12/20 2006/12/20 2006/12/20 2006/12/20 2006/12/20 2006/12/20 2006/12/21 2006/12/21 2006/12/21 2006/12/22 2006/12/21 2006/12/28 2006/12/27 2006/12/27 2006/12/27 2006/12/27 2006/12/27 2006/12/27 2006/12/27 2006/12/27 2006/12/27 2006/12/27 2006/12/27 2006/12/27 2006/12/27 2006/12/27 2006/12/27 2006/12/27 2006/12/27 2006/12/28 2006/12/28 Draeger Medical Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. Terumo China (H.K.) Ltd. Maquet Hong Kong Limited Maquet Hong Kong Limited Bio-Rad Pacific Ltd. Guidant Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. Siemens Ltd. Siemens Ltd. Bausch & Lomb (Hong Kong) 2877 3077 2783 1838 2866 0811 2393 9511 2393 9511 2272 8922 2593 2235 2783 1838 2870 7533 2870 7533 2213 3179 The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed all affected users. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. Roche Diagnostics (Hong Kong) Limited Direct Health Ltd. Boston Scientific H. K. Ltd. B. Braun Medical (Hong Kong) Becton Dickinson Asia Ltd. Johnson & Johnson Medical Hong Kong Johnson & Johnson Medical Hong Kong Ultronics Enterprise Ltd. Boston Scientific H. K. Ltd. 2485 7555 2528 1109 2960 7117 2277 6125 2575 8668 2738 2818 2738 2818 2764 5208 2960 7117 The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed all affected users. The local agent informed all affected users. The local agent informed all affected users. The local agent informed all affected users. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. Gambro China Ltd. 2576 2688 The local agent informed that no affected units had been distributed in Hong Kong. Guidant Hong Kong Ltd. Medtronic International, Ltd. Smiths Medical (S.E. Asia) Ltd. Johnson & Johnson Medical Hong Kong AMO Asia Ltd. Terumo China (H.K.) Ltd. Becton Dickinson Asia Ltd. AMO Asia Ltd. 2593 2235 2919 1362 2317 0988 2738 2818 2401 5861 2866 0811 2575 8668 2401 5861 The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed all affected users. The local agent informed all affected users. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed all affected users. Boston Scientific H. K. Ltd. Medtronic International, Ltd. 2960 7117 2919 1362 The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong.
2006/011/023/291/013 2006/012/007/081/002 2006/012/018/291/025 2006/002/015/291/004 Z-0206-2007 / Z-0207-2007 Z-0148-2007 Z-0253-2007 Z-0267-2007 Z-0268-2007 2006/008/017/081/001 2006/012/004/601/443 2006/011/024/081/004 2004/011/004/151/010
FSCA FSCA FSCA Firm Initiated Field Action FSCA Class I Class II Class II Class II Class II FSCA FSCA FSCA FSCA Firm Initiated Field Action
Z-0233-2007 to Z-0242-2007 Class II
2006/011/023/081/010 Z-0261-2007 & Z-0262-2007 Z-0263-2007 Z-0258-2007 & Z0259-2007 Z-0269-2007
FSCA Class I Class I Class II Class II
Z-0270-2007 to Z-0287-2007 Class II Z-0288-2007 Z-0302-2007 Z-0291-2007 Z-0294-2007 Recall # 33015 Recall # 33014 Recall # 32786 Recall # 33044 Recall # 33048 Recall # 33053 Recall # 33065 Recall # 33214 2006/012/015/081/007 2006/012/008/081/012 Class II Class II Class II Class II Type II Type II Type II Type II Type II Type III Type III Type III FSCA FSCA
Medical Device Control Office
124
Department of Health The Government of the HKSAR
Monthly Summary of Medical Device Safety Alerts - November 2006
Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. Description of Product Source of Reference No. by Source Alert Type by Source Date of Issue Local Agent Agent Contact (YYYY/MM/DD) No. Information Telephone No. Kendall Monoject Syringe with Hypodermic Needle, 3cc syringe SA060332 with 27 ga A-Bevel Needle (3cc-27x1-1/4 A) Product # FDA Z-0051-2007 Class II Recall 2006/11/01 Tyco Healthcare (HKSAR) Limited 2574 3251 888153744 GE ApexPro FH Telemetry System, Software versions v3.8 and GE Medical Systems Hong Kong SA060333 FDA Z-0054-2007 Class II Recall 2006/11/01 2783 1838 Ltd. earlier Depuy PFC Oval Dome Patella, Part Number 960100, Lot: Johnson & Johnson Medical Hong SA060334 FDA Z-0057-2007 Class II Recall 2006/11/01 2738 6080 2203528 Kong Cardinal Health Cardiovascular Split Drape II, various models SA060335 FDA Class II Recall 2006/11/01 N/A N/A Z-0058-2007 to Z-0062-2007 and lot numbers Siemens Medical Solutions Sienet Cosmos V15C, model SA060336 number 10018969, Serial numbers 1001, 1010, 1011, 1028, FDA Z-0069-2007 Class II Recall 2006/11/01 Siemens Ltd. 2870 7533 and 1029Medical Solutions Syngo Imaging, Sienet Sky and Siemens SA060337 Sienet Magic View 300 picture archiving and communications FDA Z-0070-2007 to Z-0072-2007 Class II Recall 2006/11/01 Siemens Ltd. 2870 7533 systems (1) Cook Asia (Hong Kong) Ltd.; (2) (1) 2781 0232; (2) 2541 Cook Zilver 635 Biliary Stent, Catalog # ZIB6-80-4.0-40, lot FDA Z-0080-2007 Class II Recall 2006/11/01 A.R. Burkhill & Sons (Hong Kong) SA060338 1041 1722922 Ltd. Radiometer America Radiance Data Management System, SA060339 Software Version 2.60, modification for the ABL800 Flex Blood FDA Z-0115-2007 Class II Recall 2006/11/01 N/A N/A Gas Analyzer, Catalog Numbers: 914-418 and 914-426 Field Safety Corrective SA060340 Siemens MODULARIS Uro endourology tables MHRA 2006/010/010/291/005 2006/11/01 Siemens Ltd. 2870 7533 Action SA060341 Ferno Falcon Six stretcher trolleys Boston Scientific Mach 1 Peripheral Guide Catheter, lot # SA060342 575765 SA060343 Welch Allyn Propaq LT patient monitors SA060344 Abbott CELL-DYN 22 calibrators and controls SA060345 Ansell Micro-Touch Nitrile examination gloves SA060346 Hardy Media HardyCHROM 0157, Catalogue Number G305, Lot numbers 06192 and 06235 MHRA Boston Scientific H. K. Ltd. MHRA MHRA MHRA FDA FDA Respironics, Inc. MHRA MHRA FDA Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada 2005/008/001/401/006 N/A 2006/011/001/081/001 2006/011/003/601/388 2006/010/031/081/002 Z-0078-2007 Z-0116-2007 N/A 2006/011/001/081/010 2006/009/004/081/008 N/A 32674 32639 32598 32528 32627 32593 32498 32451 Field Safety Corrective Action Urgent Medical Device Recall Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Class II Recall Class II Recall Urgent Medical Device Recall Field Safety Corrective Action Field Safety Corrective Action Firm Press Release Type II Recall Type II Recall Type II Recall Type II Recall Type II Recall Type II Recall Type II Recall Type II Recall 2006/11/01 2006/11/03 2006/11/06 2006/11/08 2006/11/08 2006/11/08 2006/11/08 2006/11/09 2006/11/09 2006/11/09 2006/11/09 2006/11/13 2006/11/13 2006/11/13 2006/11/13 2006/11/13 2006/11/13 2006/11/13 2006/11/13 N/A Boston Scientific H. K. Ltd. N/A Abbott Laboratories Ltd. N/A N/A N/A Celki Medical Company Becton Dickinson Asia Ltd. N/A N/A Sanko Medical Systems (H.K.) Ltd. Sanko Medical Systems (H.K.) Ltd. Arjo Far East Limited Agfa Hong Kong Ltd. N/A N/A Elekta Ltd. Draeger Medical Hong Kong Ltd. N/A 2960 7117 N/A 2806 4201 N/A N/A N/A 2268 9229 2575 8668 N/A N/A 2384 0688 2384 0688 2508 9553 2555 9421 N/A N/A 2892 4320 2877 3077 The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed all affected users. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. With affected units in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. Remarks
The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong.
The local agent informed that no affected units had been distributed in Hong Kong.
The local agents informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong.
SA060347 Venoscope Neonatal Transilluminator, Model NT01 Respironics REMstar Heated humidifier, model nos. 1007861, SA060327 R1007861, JP1007861 and 1005732, Serial no: H045582 to H239662 (inclusive) SA060348 BD MultiVisc viscoadaptive solutions (catalog number 581745) SA060349 Getinge steam sterilizers, various models Endologix Visiflex bifurcated Delivery Catheters, 155mm, used SA060350 for the Powerlink System (models 25-16-155BL and 28-16155BL) SA060351 Toshiba Medical Systems Aquilion and Aquilion CFX Edition SA060352 Toshiba Medical Systems Aquillion 16-Slice System SA060353 Arjo Minstrel Lift with Scale AGFA CR NX Modality Workstation, model or catalog # ES885, versions NX 1.0.2402 and NX 1.0.2405 Implant Innovations ITHA52 Certain EP Healing Abutment, Lot SA060355 or Serial # 560988 Calley & Currier Laminated Wooden Crutches, various models SA060328 and catalog numbers Elekta Instruments AB Leksell Gamma Knife C Version 1.2/4C, SA060356 Lot or Serial # 4310 and 4336 SA060354 SA060357 Draeger Medical Narkomed 6000 Series Anesthesia Machine
Medical Device Control Office
125
Department of Health The Government of HKSAR
SA060358 Toshiba Medical Systems Opart MRI System SA060359 SA060360 SA060361 SA060362 SA060329 SA060363 SA060364 Immucor Panocell-16, 16 x 3ml, model or catalog # 0002332, lot or serial # 35411 Smith & Nephew Profix Hall 3/4 Fanned Sawblade, model or catalog # 71512903 Beckman Coulter EPOCS SL Flow Cytometers with EXPO 32 ADC Software Smiths Medical Level 1 D-60HK and DI-60HL Normothermic I.V. Fluid Administration Sets Ciba Vision CSI Daily Wear, CSI Flexible Wear and CSI Toric soft (hydrophilic) contact lenses Enpath Medical pacemaker lead adapter and Angel Medical Systems Lead Adaptor system Hydrocision SpineJet XL MIS 20 and SpineJet XL MIS 30 degree Handpieces, Catalog Numbers 58662 and 58663
Health Canada Health Canada Health Canada MHRA MHRA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA
32523 32531 32280 2006/011/010/291/002 2006/011/009/081/009 Z-0018-2007 to Z-0020-2007 Z-0120-2007 & Z-0121-2007 Z-0123-2007 & Z-0124-2007 Z-0130-2007 to Z-0144-2007 Z-0151-2007 Z-0152-2007 Z-0153-2007 Z-0154-2007 & Z-0155-2007 Z-0156-2007 Z-0159-2007 Z-0160-2007
Type II Recall Type II Recall Type II Recall Field Safety Corrective Action Field Safety Corrective Action Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall
2006/11/13 2006/11/13 2006/11/13 2006/11/13 2006/11/14 2006/11/15 2006/11/15 2006/11/15 2006/11/15 2006/11/15 2006/11/15 2006/11/15 2006/11/15 2006/11/15 2006/11/15 2006/11/15
Sanko Medical Systems (H.K.) Ltd. Uninet Technology Ltd. Smith & Nephew Healthcare Ltd. Beckman Coulter Hong Kong Ltd. Smiths Medical (S.E. Asia) Ltd. Ciba Vision Hong Kong Ltd. N/A N/A Johnson & Johnson Medical Hong Kong HealthCare Diagnostics Ltd. N/A N/A N/A N/A Maquet Hong Kong Limited
2384 0688 2838 8423 2645 8703 2240 6260 2317 0988 2814 2121 N/A N/A 2738 6080 2563 5193 N/A N/A N/A N/A 2393 9511
The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong.
The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed all affected users. The local agent informed all affected users. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong.
SA060365 DePuy Spine Bremer Halo System, various models Ortho-Clinical Diagnostics VITROS Chemistry Products GLU SA060366 DT Slides GEN 56, REF (Catalog #) 153 2316, 25 slides per box Hitachi Medical Systems Echelon Magnetic Resonance Imaging SA060367 System, Serial Number: V001 Precision Medical Easy Mate Portable Liquid Oxygen System SA060368 (container), PM22010 Series, Model number 2201, serial numbers P002892 through P005116 Access Point Medical Heavy Duty Rollators (rolling walker), SA060369 Product Codes: RL12010HD and RL12011 Lumiport DermaStyle Chroma 2-blue and red light device SA060370 indicated to be used in treating skin blemishes, portable home therapy SA060371 Maquet Jostra HL-20 Heart Lung Machine - guiding pins Cook Endoscopy Fusion OMNI ERCP Catheter, Lot number W2243511 USA Instruments 1.5T HD Head Neck Spine Array (Model 2416329, for GE 1.5T Excite MR System) and 3.0T HD Head SA060373 Neck Spine Array (Model 2415545, for GE 3.0T Excite MR System) SA060330 BD Insulin Pen Needles, 31G 5mm, Catalog No. 320129 SA060372 Beckman Coulter Access Immunoassay Systems Thyroglobulin SA060374 Antibody SA060375 Draeger Medical Infant Warmer - RW82VHA-1C SA060376 Novagen Ltd 2mm Angled Suction Tip SA060377 Molnlycke Health Card Camera Drape - ProcedurePak Trays SA060378 Medtronic SynchroMed® and IsoMed® Implantable Pain Infusion Pumps, various models
The local agent informed that no affected units had been distributed in Hong Kong.
(1) Cook Asia (Hong Kong) Ltd.; (2) (1) 2781 0232; (2) 2541 The local agent informed that no affected units had been A.R. Burkhill & Sons (Hong Kong) 1041 distributed in Hong Kong. Ltd. N/A Becton Dickinson Asia Ltd. Beckman Coulter Hong Kong Ltd. Draeger Medical Hong Kong Ltd. Onwon Trading Limited N/A Medtronic International, Ltd. N/A N/A N/A N/A Tyco Healthcare (HKSAR) Limited Boston Scientific H. K. Ltd. N/A 2575 8668 2240 6260 2877 3077 2757 7569 N/A 2919 1362 N/A N/A N/A N/A 2574 3251 2960 7117 The local agent informed all affected users. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed all affected users. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent confirmed having no record of importing the affected devices into Hong Kong.
FDA Becton Dickinson and Company (Japan) MHRA MHRA MHRA MHRA Medtronic International, Ltd. MHRA MHRA MHRA MHRA
Z-0163-2007 & Z-0164-2007 N/A 2006/011/014/291/014 2005/005/025/401/001 2006/011/010/401/006 2006/011/013/081/007 N/A 2004/012/001/061/029 2006/011/013/291/002 2006/010/013/601/34 2006/008/031/291/002 2006/011/014/081/008 N/A
Class II Recall Voluntary Recall Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Important Patient Safety Management Information Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Medical Device Customer Notification
2006/11/15 2006/11/15 2006/11/15 2006/11/15 2006/11/15 2006/11/16 2006/11/17 2006/11/17 2006/11/20 2006/11/20 2006/11/20 2006/11/20 2006/11/21
SA060379 Ferno Restraining straps/harness-Pedi-Mate 678 SA060380 Owen Mumford Unistik 3 Neonatal & Laboratory/Confort/Normal Full Spectrum Lighting T/a S.A.D. Lightbox Company Machine SA060381 Therapy-LPD24 SA060382 Bard Access Systems HemoGlide Catheter Kits
Tyco Healthcare OptiVantage DH Contrast Media Injection SA060383 MHRA System Boston Scientific System Drape (IVUS motor drive sterile plastic Boston Scientific H. K. SA060384 cover), lot numbers M846990, M835770 and M844470 Ltd.
Medical Device Control Office
126
Department of Health The Government of HKSAR
Boston Scientific Jagwire High Performance Guidewire (lot # Boston Scientific H. K. SA060385 8887513) and Jagwire High Performance Extendable Guidewire Ltd. (lot # 8887514) Specific Lots of AMO Lens Plus OcuPure Saline, COMPLETE SA060331 Multi-Purpose Solutions, and COMPLETE MoisturePLUS MultiPurpose Solutions (Starter Kits) SA060386 SA060387 Roche Diagnostics Acc-chek Multclix, Softclix, Softclix Plus and CoaguChek Softclix single-patient self-testing lancing systems Philips Allura X-per FD10/10 and FD20/10 X-ray and fluoroscopy systems AMO Asia Limited
N/A
Urgent Medical Device Recall
2006/11/21
Boston Scientific H. K. Ltd.
2960 7117
The local agent informed that no affected units had been distributed in Hong Kong.
N/A
Voluntary Recall Field Safety Corrective Action Class II Recall
2006/11/22
AMO Asia Limited Roche Diagnostics (Hong Kong) Limited Philips Electronics Hong Kong Ltd.
2401 5811 and 2401 5812 2485 7555 2821 5480
Click on the Press Release by AMO Asia for details: Press Release AMO's The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong.
MHRA FDA
2006/009/012/291/010 Z-0165-2007 & Z-0166-2007
2006/11/21 2006/11/22
Data Innovations Instrument Manager Version 8:00, 8.01, 8.02, SA060388 8.03 or 8.04 with Specimen Management and using Results/Edit/ReleaseScreen (R/E/R) Baxter Meridian hemodialysis instruments, product codes SA060389 5M5576 and 5M5576R Bemis 5 Qt. Wallmount Sharps Container, Model 150, Regular SA060390 Size Olsen Medical MIDAS TOUCH Electrosurgical/102 mm (4 inch) SA060391 Blade Electrodes, Disposable, Sterile Single Use Device, Part #30-0012 and Model #30-0002 Philips Medical Systems M3001A Multi Measurement Server (MMS) and M1020B Pulse Oximetry Module Philips FAST Sp02 SA060392 and Pulse Oximetry Nellcor OxiMax Compatible used with the IntelliVue or M3/M4 patient monitor M1002 Sorenson Medical ambIT Ambulatory Infusion Pump Cassettes, SA060393 REF numbers 220139, 220140, 220266 and 220267, all serial numbers Eatonform Doc-U-Dose Prescription Management System, Item SA060394 8-PKIT, Carton numbers: 16 through 39 Zimmer Spine ST360 Distal Thread Reduction Guide Pins, Lot SA060395 numbers: P031530, P031650, P040389, P040111, P051160, P051161 Trionix Research Laboratory BIAD Classic 24 (24 inch SA060396 collimator), Serial numbers B-102 through B-184 Ekos Lysus Transport Stand (infusion stand), part number SA060397 4896-003 Balt Extrusion Flow Dependent Micro-Catheter, models MAGIC SA060398 1.2FM, MAGIC MP and MAGIC STD Tornier Latitude Elbow Prosthesis Radial Head, models or SA060399 catalog # DKY056, DKY057, DKY058 and DKY059 SA060400 Rocket Medical Fetal Blood Sampling Kit SA060401 Bard Ltd. Stone Basket - 042310, 042313, 042316, 043310, 043313, 043316 Elekta Instruments AB Leksell Gamma Knife, model or catalog SA060402 # 912800 SA060403 Rocialle InHealth Sterile Procedure Pack - Basic Pack SA060404 SA060405 SA060406 SA060407 SA060408 SA060409 Abbott AxSYM Matrix Cells, Product List No: 8A73-02, Lot # 37618Q100 Plus Orthopedics UC-PLUS Solution Unicondylar Knee Systems Exactech Optetrak B-series cemented finned tibial tray, size 2f/2t, catalog # 220-04-02, serial numbers 0886395 - 0886424 Iris Sample Processing StatSpin Express 3 Centrifuge with RTX8 Rotor Model: M502, Serial numbers: B1562 to B1738 Dako Colorado Eridan Automated Slide Stainer and Support Cart, REF E300 and E300SC1 Datex-Ohmeda Tec 6 Plus Desflurane Vaporizer, various serial numbers
FDA FDA FDA FDA
Z-0167-2007 Z-0169-2007 Z-0170-2007 Z-0182-2007
Class II Recall Class II Recall Class II Recall Class II Recall
2006/11/22 2006/11/22 2006/11/22 2006/11/22
Data Innovations Asia Baxter Healthcare Ltd. N/A N/A
2398 3182 2807 8556 N/A N/A The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong.
FDA
Z-0183-2007 & Z-0184-2007
Class II Recall
2006/11/22
Philips Electronics Hong Kong Ltd.
2876 7525
FDA FDA FDA FDA FDA Health Canada Health Canada MHRA MHRA Health Canada MHRA FDA FDA FDA FDA FDA FDA FDA
Z-0185-2007 to Z-0188-2007 Z-0189-2007 Z-0190-2007 Z-0193-2007 Z-0195-2007 30937 32628 2006/007/005/601/166 2006/011/024/601/421 32733 2006/011/009/291/005 Z-0117-2007 Z-0191-2007 & Z-0192-2007 Z-0196-2007 Z-0198-2007 Z-0199-2007 Z-0201-2007 Z-0202-2007 to Z-0205-2007
Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Type II Recall Type II Recall Field Safety Corrective Action Field Safety Corrective Action Type II Recall Field Safety Corrective Action Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall
2006/11/22 2006/11/22 2006/11/22 2006/11/22 2006/11/22 2006/11/27 2006/11/27 2006/11/27 2006/11/27 2006/11/27 2006/11/28 2006/11/29 2006/11/29 2006/11/29 2006/11/29 2006/11/29 2006/11/29 2006/11/29
N/A N/A Zimmer PTE Ltd. (Hong Kong branch) N/A N/A N/A N/A N/A N/A Elekta Ltd. N/A Abbott Laboratories Ltd. N/A N/A N/A N/A Hong Kong Oxygen & Acetylene Co. Ltd. N/A
N/A N/A 2992 0968 N/A N/A N/A N/A N/A N/A 2892 4320 N/A 2806 4201 N/A N/A N/A N/A 2666 1942 N/A
The manufacturer informed that no affected units had been distributed in Hong Kong.
The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong.
The manufacturer informed that no affected units had been distributed in Hong Kong.
The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong.
The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong.
SA060410 Access Point Medical Canes, various models
The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong.
Medical Device Control Office
127
Department of Health The Government of HKSAR
SA060411 SA060412 SA060413
SA060414 SA060415
Medtronic Vascular Pioneer Catheter (Crosspoint TransAccess Catheter), Model TA-XP-001, all codes Zimmer NexGen Complete Knee Solution Legacy Knee Tibial Component, Catalog no. 05-5998-038-02, Lot 60472442 Zimmer Trabecular metal shoulder instrumentation proximal provisional humeral stem, Catalog no. 00-4309-018-10, Lots: 60457716 and 60492624 Konica Minolta PrintLink III Model - ID/IV, product code no. 0770, 0771 Medical Imaging Communication Device Model IV product code 5000230 Model ID, product code 5000330 Vygon Paediatric 96Hr IV Filter 0.22M + extension line 0807.205
FDA FDA FDA
Z-0208-2007 Z-0209-2007 Z-0210-2007
Class II Recall Class II Recall Class II Recall
2006/11/29 2006/11/29 2006/11/29
Medtronic International, Ltd. Zimmer PTE Ltd. (Hong Kong branch) Zimmer PTE Ltd. (Hong Kong branch) Konica Minolta Business Solutions (HK) Ltd. N/A Smiths Medical (S.E. Asia) Ltd. N/A Bayer Healthcare Ltd. (Hong Kong)
2919 1362 2992 0968 2992 0968
The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. 1 affected unit in Hong Kong.
FDA MHRA MHRA MHRA MHRA
Z-0220-2007 2006/011/017/401/001 2006/011/022/291/010 2006/011/003/261/001 2006/011/027/601/428
Class II Recall Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action
2006/11/29 2006/11/29 2006/11/29 2006/11/29 2006/11/29
2565 8181 N/A 2317 0988 N/A 2814 4829
SA060416 Smiths Medical International Monitor Patient-BCI Autocorr 3404 SA060417 Pegasus Ltd. Altas and Paragon Bed Frames SA060418 Bayer HealthCare ADVIA Centaur CP Immunoassay System
Medical Device Control Office
128
Department of Health The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - October 2006
Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. Description of Product Source of Reference No. by Source Alert Type by Source Date of Issue Local Agent (YYYY/MM/DD) No. Information Computerized Medical Systems Software Releases 2.1.0 SA060247 Health Canada 32273 Type II Recall 2006/10/02 N/A 4.3.0, all lot numbers Hill-Rom Patient Pendants, model or catalog # P3207A01 & SA060248 Health Canada 32294 Type II Recall 2006/10/02 Solar Medical Ltd. P3207A02 Radiometer Medical APS CAL 2 Solution, model or catalog # SA060249 Health Canada 32100 Type II Recall 2006/10/02 N/A S1730, lot or serial number QR-02 Baxter Healthcare Colleague 3 Volumetric Infusion Pump, SA060250 models 2M8153, 2M8153R, 2M8163, 2M8163R, DNM8153 & Health Canada 32333 Type II Recall 2006/10/02 Baxter Healthcare Ltd. DNM8153R Ondine Biopharma Periowave Disinfection System Footswitch, Health Canada 32178 Type II Recall 2006/10/02 N/A SA060251 model or catalog # PW1002 and PW1100, lot or serial number PW-D06-00001 to PW-D06-00400 Applied Medical Technology Endovive Enteral Feeding Device, Boston Scientific H. K. Medical Device Market SA060252 N/A 2006/10/03 Boston Scientific H. K. Ltd. specific lots Ltd. Withdrawal Huntleigh birthing beds, Models 35000 and 170000; Hoskins SA060253 MHRA MDA/2006/057 Action 2006/10/03 N/A Birthcare, Models L10 and L05 Baxter Healthcare, Administration Set-Continu Flo Solution Sets Field Safety Corrective SA060254 MHRA 2006/009/020/291/016 2006/10/03 Baxter Healthcare Ltd. with Check Valve Action Field Safety Corrective SA060255 B. Braun Arterial / Venous Blood Line, 7210697 MHRA 2006/009/026/291/011 2006/10/03 B. Braun Medical (Hong Kong) Ltd. Action Terumo Khuri Myocardial PH Monitoring System, Catalog SA060256 FDA Z-1517-06 Class II Recall 2006/10/04 Terumo China (H.K.) Ltd. number 7205 Kerr RempBond Clear Syringes (base and catalyst kit), a temporary dental cement, Part Number 28637 BD 1mL Safety Glide Allergy and Tuberculin Syringes. Reorder SA060258 Number 305945 and 305950 Ogenix EpiFLO SD Clinical Users Guide (CUG), Part #01-100SA060259 1000000 International Medsurg Connection Allegiance Esmark SA060260 Bandages, catalog numbers 24593-043A, 24593-044A, 24593063A and 24593-064A SA060257 SA060261 INO Therapeutics INOvent System O Ring Failures SA060262 Codan Great Britain Pump volumetric Argus 708 SA060263 SA060264 SA060265 SA060266 SA060267 Abbott Laboratories AsSYM Myoglobin Reagent Kit List Number 7K48-20 Varian 4D Integrated Treatment Console treatment control station for radiation therapy linear accelerators GE Healthcare Technologies (Prev Datex Ohmeda) Monitor Patient - N-AC BD Pharmingen No Azide/Low Endotoxin Mouse Anti-Human HLA-DR, DP, DQ Monoclonal Antibody, Clone TU39, Cat. No. 555556 Prorhtym Cardiac ablation system - 25mm & 30mm HIFU ablation catherter FDA FDA FDA FDA MHRA MHRA MHRA Varian Medical Systems Pacific Inc. MHRA Becton Dickinson Asia Ltd. MHRA MHRA MHRA FDA FDA FDA FDA FDA Z-1524-06 Z-1525-06 Z-1526-06 Z-1527-06 to Z-1530-06 2006/004/003/401/004 2006/007/012/291/010 2006/009/029/601/319 2006-022 2006/009/027/601/315 N/A 2006/007/013/081/002 2006/010/002/901/325 2006/008/015/401/002 Z-0704-06 Z-1301-06 to Z-1303-06 Z-1514-06 Z-1485-06 Z-1543-06 to Z-1549-06 Class II Recall Class II Recall Class II Recall Class II Recall Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Urgent Medical Device Correction Field Safety Corrective Action Customer Notification Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall 2006/10/04 2006/10/04 2006/10/04 2006/10/04 2006/10/04 2006/10/04 2006/10/04 2006/10/06 2006/10/06 2006/10/09 2006/10/10 2006/10/11 2006/10/11 2006/10/11 2006/10/11 2006/10/11 2006/10/11 2006/10/11 N/A Becton Dickinson Asia Ltd. N/A N/A Hong Kong Oxygen & Acetylene Co. Ltd. N/A Abbott Laboratories Ltd. Varian Medical Systems Pacific Inc. GE Medical Systems Hong Kong Ltd. Becton Dickinson Asia Ltd. N/A Abbott Laboratories Ltd. N/A GE Medical Systems Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. Smith & Nephew Healthcare Ltd. GE Medical Systems Hong Kong Ltd. Evergreen Health Care Ltd. Agent Contact Telephone No. N/A 2425 0926 N/A 2807 8556 N/A 2960 7117 N/A 2807 8556 2277 6125 2866 0811 N/A 2575 8668 N/A N/A 2666 1942 N/A 2806 4841 2724 2836 2783 1838 2575 8668 N/A 2806 4841 N/A 2783 1838 2783 1838 2645 8703 2783 1838 2893 0694 The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed all the affected users. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. Remarks 1 affected unit was distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong.
SA060268 Abbott Laboratories CELL-DYN 22 Calibrators-99120-01 SA060269 Cory Bros Ltd, Tubing suction - Ref: CST/50/6 GE OEC Medical Systems MiniView 6800 Digital Mobile C-arm fluoroscopic x-ray system GE OEC Medical Systems 9900 Elite Digital Mobile C-arm XSA060271 ray system, 9800 Fluoro C-arm X-ray system and RUS Tool Version Software Smith & Nephew Hip Positioning System with various System SA060272 Components SA060270 SA060273 GE Precision RX/I System, all units Pointe Scientific Alcohol reagent sets and control standards, SA060274 various models
Medical Device Control Office
129
Department of Health The Government of HKSAR
GE OEC Medical Systems 4 inch Anterior Cervical Post, Part SA060275 Number: 1006385 or 1006385-NAV, an accessory used with the InstaTrak 3500 plus and 9800 C-Arm Navigation systems Thoratec brand TLC-11 Portable Ventricular Assist Device SA060276 (VAD) Driver Stryker Navigation Systems with Dell laptop computer model SA060277 D800 Smith & Nephew Journey Nonporous Fin-Stem Tibial Punch, SA060278 Genesis II Nonporous Fin-Stem Tibial Punch and Genesis II Oversized Nonporous Fin-Stem Tibial Punch SA060279 Actamed Ltd Ranger High Flow Blood/Fluid Warming Sets SA060166 Jenx Ltd. Seating support systems for children SA060280 BD Procount Kit, Part No. 340498, Lot No. 51184 and 57281
FDA FDA FDA FDA MHRA MHRA
Z-0001-07 Z-0004-07 Z-0005-07 to Z-0008-07 Z-0009-07 to Z-0011-07 2006/004/027/601/094 MDA/2006/059 N/A
Class II Recall Class II Recall Class II Recall Class II Recall Field Safety Corrective Action Immediate Action Product Field Action Notification Important Information
2006/10/11 2006/10/11 2006/10/11 2006/10/11 2006/10/12 2006/10/12 2006/10/13
GE Medical Systems Hong Kong Ltd. N/A Stryker Hong Kong Smith & Nephew Healthcare Ltd. N/A N/A Becton Dickinson Asia Ltd.
2783 1838 N/A 2518 6915 2645 8703 N/A N/A 2575 8668
The local agent informed that no affected units had been distributed in Hong Kong.
The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong.
SA060237
SA060236 SA060281 SA060282 SA060283
Becton Dickinson Asia Ltd. St. Jude APS III Model 3500/3510 and Merlin PCS Model 3650 programmers used with certain St. Jude Identity pacemakers St. Jude Medical, Inc. (Identity SR Model 5172, Identity DR Model 5370 and Identity XL DR Model 5376) LifeScan OneTouch Basic/Profile (lot # 272894A, 2619932, 2606340) and OneTouch Ultra (lot # 2691191) Blood Glucose FDA Test Strips AGA Medical Corporation Delivery System Amplatzer TorqVue MHRA Delivery and Exchange Systems BD Procount Progenitor Cell Enumeration, Part No. 340498, Lot Health Canada No. 45602 Walter Lorenz Surgical Lactosorb Suspension Screw, model or Health Canada catalog # 915-2335, lot or serial # 753200 Health Canada
The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent has already informed all the concerned hospitals and doctors.
N/A
2006/10/13
St. Jude Medical (Hong Kong) Ltd.
2996 7650
P06-167 2006/010/003/081/006 32353 32288 32120 32374 32375 32310 N/A N/A N/A N/A 2006/010/013/601/347 Z-0015-2007 Z-0027-2007 Z-0029-2007 Z-0030-2007 Z-0031-2007 Z-0035-2007 N/A
FDA News Field Safety Corrective Action Type II Recall Type II Recall Type II Recall Type II Recall Type II Recall Type II Recall Urgent Medical Device Recall Urgent Medical Device Recall Urgent Medical Device Recall Important Notification Field Safety Corrective Action Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Press Release
2006/10/13 2006/10/16 2006/10/16 2006/10/16 2006/10/16 2006/10/16 2006/10/16 2006/10/16 2006/10/17 2006/10/17 2006/10/17 2006/10/17 2006/10/17 2006/10/18 2006/10/18 2006/10/18 2006/10/18 2006/10/18 2006/10/18 2006/10/19
Johnson & Johnson Medical Hong Kong Beijing Since Medical Scientific Co. Ltd. Becton Dickinson Asia Ltd. N/A Gambro China Ltd. BioMerieux China Limited Beijing Ji Yuan Electronic Co. N/A Boston Scientific H. K. Ltd. Boston Scientific H. K. Ltd. Boston Scientific H. K. Ltd. Boston Scientific H. K. Ltd. Elekta Ltd. N/A 3M Hong Kong Ltd. N/A N/A Agfa Hong Kong Ltd. Haemonetics (Hong Kong) Limited Roche Diagnostics (Hong Kong) Limited
2735 8262 9262 1527 2575 8668 N/A 2576 2688 2356 7033 (86)10-6202-3856 N/A 2960 7117 2960 7117 2960 7117 2960 7117 2891 2208 N/A 2806 6314 N/A N/A 2555 9421 2868 9218 2485 7555
Updated on 2006/10/23. Please see SA060241 for details.
The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. 1 affected unit was distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. 3 affected units were distributed in Hong Kong.
SA060284 Teraklin AG Mars Treatment Kit SA060285 SA060286 SA060287 SA060288 SA060289 SA060290 SA060291
Biomerieux Slidex Pneumo-Kit, model or catalog # 58821, lot or Health Canada serial # 50417 Michigan Instruments Thumper Mechanical CPR Device, model Health Canada or catalog # 1007 Randox Laboratories Fructosamine Control Level 1, lot or serial Health Canada # 239FR Boston Scientific Interlock Detachable Coils For Occlusion, lot Boston Scientific H. K. number 6628239 Ltd. Boston Scientific Renegade 18 Microcatheter, lot number Boston Scientific H. K. 7513978 Ltd. Boston Scientific Stainless Steel Greenfield Vena Cava Filter, Boston Scientific H. K. lot number 7826572 Ltd. Advanced Bionics Linear Family Leads (product numbers SCAdvanced Bionics 2108, SC-2138, SC-2148 series) MHRA FDA FDA FDA FDA FDA FDA FDA
The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong.
SA060292 Elekta Ltd. Precise Desktop R4.2 and DesktopPro R5.0 Thoratec brand Sealed Arterial Cannula for use with the Thoratec Ventricular Assist Device System 3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 SA060294 Sterilization Systems, Lot numbers 2006-12 AA through 200806 AB Medical Systems MRP-7000 and AIRIS Magnetic Hitachi SA060295 Resonance Imaging Systems, Software Versions: V7.0A to V7 0J Arrow Double-Lumen Balloon Wedge Pressure Catheter, for SA060296 sampling blood for oxygen levels and measuring pressures in the right heart SA060293 SA060297 AGFA CR DX-S Image Intensified Fluoroscopic X-ray system Haemonetics SmartSuction Harmony Powered Suction Device, SA060298 Model number: HAR-E-115-US SA060299 Roche Diagnostics CoaguChek PT test strips
The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong.
Medical Device Control Office
130
Department of Health The Government of HKSAR
SA060239 Sunrise Medical Jay J2, Wheelchair back SA060240 Medtronic SynchroMed EL Programmable Infusion Pumps, Models 8627-10, 8627-18, 8627L-10, 8627L-18
MHRA FDA Medtronic International, Ltd. MHRA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA FDA MHRA MHRA MHRA Respironics, Inc. Health Canada Health Canada
MDA/2006/060 Z-0022-0007 N/A 2006/007/027/291/001 P06-174 Z-0026-2007 Z-0034-2007 Z-0036-2007 & Z-00372007 Z-0039-2007 & Z-00402007 Z-0041-2007 Z-0042-2007 Z-0043-2007 Z-0044-2007 Z-0045-2007 Z-0048-2007 Z-0049-2007 Z-0050-2007 Z-0052-2007 & Z-00532007 Z-0055-2007 2006/010/004/401/021 2006/070/019/601/356 2006/010/020/081/015 N/A 32430 32469
Action Class I Recall Voluntary Field Corrective Action Field Safety Corrective Action FDA News Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Urgent Medical Device Recall Type I Recall Type II Recall
2006/10/19 2006/10/20 2006/10/20 2006/10/23 2006/10/23 2006/10/25 2006/10/25 2006/10/25 2006/10/25 2006/10/25 2006/10/25 2006/10/25 2006/10/25 2006/10/25 2006/10/25 2006/10/25 2006/10/25 2006/10/25 2006/10/25 2006/10/25 2006/10/25 2006/10/25 2006/10/25 2006/10/30 2006/10/30
N/A Medtronic International, Ltd. Medtronic International, Ltd. Olympus Hong Kong Ltd Johnson & Johnson Medical Hong Kong N/A Becton Dickinson Asia Ltd. N/A N/A GE Medical Systems Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. Johnson & Johnson Medical Hong Kong N/A N/A Draeger Medical Hong Kong Ltd. N/A Medtronic International, Ltd. Beijing Since Medical Scientific Co. Ltd. GE Medical Systems Hong Kong Ltd. N/A N/A Siemens Ltd. Celki Medical Company N/A N/A
N/A 2919 1362 2919 1362 2376 1805 2735 8262 N/A 2575 8668 N/A N/A 2783 1838 2783 1838 2738 6080 N/A N/A 2877 3077 N/A 2919 1362 9262 1527 2783 1838 N/A N/A 2870 7533 2268 9229 N/A N/A
SA060300 Lenox-Maclaren Bone Fragmenter, Catalog # 9150111, all lots SA060301 SA060241 SA060302 SA060303 SA060304 SA060242 SA060305 SA060306 SA060307 SA060308 SA060309 SA060310 SA060311 SA060312 SA060313 SA060314 Olympus Life and Material Science Europa GmbH - CRP Latex C-Reactive Protein (OSR6199) LifeScan, Inc, One Touch Basic/Profile and One Touch Ultra Blood Glucose Test Strips GF Health Products ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed BD Vacutainer Push Button Blood Collection Set with Preattached Holder, Catalog numbers 367352 and 368656 Medline Industries Strider Maxi 3 and Maxi 4 Scooters, red and blue models, all serial numbers Eagle Parts and Products Models 624EZ and 624Mini Power Wheel Chairs with internally threaded wheel mount motors, Serial numbers 624EZ0010 through 624EZ0513 GE OEC 9900 Elite Fluoroscopy System with Integrated Navigation, Catalog Numbers 887208 and 887210 GE OEC 9900 Elite Fluoroscopy System, Catalog No. 887208 and 887210 Bioplate Resorbable Bone Fixation Tack, Catalog Number 890120, Item Number SG#-45, Lot number S2964090 Excelsior Medical 0.9% Sodium Chloride Flush Syringe, 2.5 mL. Product Code: E0100 under Hospira's label, Syrex, Lot: 22-0109D Eatonform Doc-U-Dose Prescription Management System, Item #8-PKIT, lots 312733, 312734, 313767 and 313768 Draeger Fabius GS Anesthesia Machine, Catalog number 8604699 Del Medical DynaRad Phantom Portable X-Ray System, Phantom model (PH-150-CM & PH-150-G) Medtronic Sofamor Danek Implant Hollow Reamer, 14 mm, REF 8951405, Lot Numbers CN04J012 and CN 06A003 AGA Medical AMPLATZER PFO Occluder, Order No. 9-PFO018 and 9-PFO-025 GE ApexPro CH Telemetry System, Software version 3.8 and earlier
Supersedes the MDA/2006/056 (Ref: SA060163). The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong.
Update to SA060236. For enquiry, please contact the local agent. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. According to FDA, distribution of affected units was limited to the United States only. Pending the manufacturer's confirmation. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong.
SA060315 Omega truCATH catheters (TCH-10) SA060316 Southern Scientific Autotilt ultrasound couches SA060317 SA060327 SA060243 SA060244 Siemens MAGNETOM Trio and MAGNETOM Trio a Tim magnetic resonance imaging systems Respironics REMstar Heated humidifier, model nos. 1007861, R1007861, JP1007861 and 1005732, Serial no: H045582 to H239662 (inclusive) BHM Medical Kwiktrak Fix Gate, Model or Catalog # 700.11500 and 700.11505 Sunrise Medical Canada 5in Wheels Kits and Guardian Walkers Teleflex Medical Sher-i-Bronch Endobronchial Tube 37Fr, Sheridan Preformed Cuffed Nasal Endo., Sheridan Preformed Cuffed Oral Endo.5mm, Sheridan Preformed Uncuffed Oral Endo. and Sheridan Tracheal Tube Exchanger AMD-Ritmed Abdominal Pads, Model or Catalog # A-7059, Lot or Serial # 2095 GE Centricity Triwin Laboratory Information System Microbiology Module, Version 7.4 Smith & Nephew Legion Offset Coupler Trials, Model or Catalog # 71434301, 71434302, 71434304 and 71434306
The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong.
The local agent informed that no affected units had been distributed in Hong Kong. With affected units in Hong Kong.
The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong.
SA060318
Health Canada
32449
Type II Recall
2006/10/30
N/A
N/A
SA060319 SA060320 SA060321
Health Canada Health Canada Health Canada
32484 32311 32286
Type II Recall Type II Recall Type II Recall
2006/10/30 2006/10/30 2006/10/30
N/A GE Medical Systems Hong Kong Ltd. Smith & Nephew Healthcare Ltd.
N/A 2783 1838 2645 8703
Medical Device Control Office
131
Department of Health The Government of HKSAR
SA060322 SA060245
Micrus Endovascular Guidewire Insertion Device, Lot or Serial # F22741, F22743 and F22744 LifeScan OneTouch SureStep Test Strips, Lot or serial # 2631383
Health Canada Health Canada MHRA MHRA MHRA MHRA
32512 32428 2006/010/025/081/009 2005/001/010/401/003 2006/010/024/181/005 2006/010/026/111/002
Type II Recall Type II Recall Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action
2006/10/30 2006/10/30 2006/10/31 2006/10/31 2006/10/31 2006/10/31
N/A Johnson & Johnson Medical Hong Kong N/A N/A N/A Beckman Coulter Hong Kong Ltd. N/A
N/A 2735 8262 N/A N/A N/A 2240 6260 N/A N/A N/A 2161 0888
ConMed Detacha Tip Multi-Use Laparoscopic Instruments and SA060323 Disposable Hand Held Graspers and Dissectors SA060324 Galls Dyna Med patient transfer sheets SA060325 Biomet modular femoral heads SA060326 SA060246a SA060246b SA060246c SA060246d Beckman Coulter FC 500 MPL flow cytometry systems with MXP software versions 2.0 & 2.1 /06030015360 /20051027500 /2005/09/18360 Alcon Opti-Free Express Contact Lens Care Solution ( ), lot number #63188F and manufacturing date
The manufacturer informed that no affected units had been distributed in Hong Kong. Extension of the recall case # SA060238. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong.
The manufacturer informed that no affected units had been distributed in Hong Kong.
Beijing Health Inspection Website
N/A N/A Public Annoucement 2006/10/31 N/A Alcon Hong Kong Ltd.
The State Food and Drug Administration (SFDA) of the PRC informed that, among the four brands, only the Alcon brand is sold in Hong Kong. Alcon Hong Kong Ltd. informed that the affected lot of its product was not distributed in Hong Kong.
Medical Device Control Office
132
Department of Health The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - September 2006
Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. Description of Product Source of Reference No. by Source Alert Type by Source Date of Issue Local Agent (YYYY/MM/DD) No. Information Varian Medical Systems Pacific Gantry Direct Drive systems in Varian High Energy Clinac linear Varian Medical Urgent Medical Device SA060167 N/A 2006/09/01 Inc. accelerators Systems Pacific Inc. Correction Field Safety Corrective Zimmer PTE Ltd. (Hong Kong SA060168 Zimmer-M/DN, Trilogy, HGP II and Herbert Bone Screws MHRA 2006/007/013/081/005 2006/09/01 Action branch) Codman EDS III Drainage System, model or catalog # 82-1731, Johnson & Johnson Medical Hong SA060169 Health Canada 32097 Type II Recall 2006/09/04 lot or serial # CGHBGC and CGHBGD Kong Smith & Nephew Hewson Suture Retrievers Item 7111-1579, lot SA060170 Health Canada 32117 Type II Recall 2006/09/04 Smith & Nephew Healthcare Ltd. or serial # 05HSM0014 Mentor Clear Advantage With Aloe MECs, model or catalog # SA060171 Health Canada 32095 Type II Recall 2006/09/04 N/A 26-06100, 26-06200, 26-06300, 26-06400 & 26-06500 Biomerieux Vitek 2 Compact 30 System, Vitek 2 Compact 60 SA060172 Health Canada 31891 Type II Recall 2006/09/04 BioMerieux China Limited System and Vitek 2 System SA060173 Kueschall Airlite Manual Wheelchair, K Series 2005 SA060174 Boston Scientific PT2 Guide Wire SA060175 Baxter Healthcare Cryote Freezing Container SA060176 SA060177 SA060178 SA060179 SA060180 SA060181 Dideco Electa and Compact Advanced Autotransfusion Wash Sets Dade Behring Limited Dimension clinical chemistry system Tacrolimus (TACR) Flex reagent cartridge (DF107) Lots: FM6334, FD6344 and FA6351 Radiometer America Transcutaneous Monitor for pO2 and pCO2, Model # TCM4 BioGenex brand Hepatitis B Virus Core Antigen Antibody and Surface Antigen Antibody Diagnostica Stago Staclot LA 20 tests, Catalog #0594, LA Assay, Hexagonal Phase Phospholipid Neutralization Assay Radiometer America safePICO Samplers, self-filling arterial blood samplers Health Canada Boston Scientific H. K. Ltd. MHRA MHRA MHRA FDA FDA FDA FDA FDA FDA FDA FDA FDA MHRA MHRA MHRA Boston Scientific H. K. Ltd. MHRA MHRA MHRA MHRA 32191 N/A 2006/008/031/081/004 2006/008/029/291/003 2006/009/004/291/014 Z-1437-06 Z-1438-06 & Z-1439-06 Z-1441-06 Z-1443-06 Z-1445-06 Z-1446-06 Z-1448-06 to Z-1450-06 Z-1454-06 to Z-1459-06 Z-1464-06 & Z-1465-06 2006/006/014/601/150 2006/008/015/121/001 2006/008/021/081/006 N/A 2006/008/010/401/007 2006/008/024/081/004 2006/008/003/401/007 2006/009/004/291/003 Type II Recall Urgent Medical Device Recall Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Urgent Medical Device Recall Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action 2006/09/04 2006/09/05 2006/09/05 2006/09/05 2006/09/06 2006/09/06 2006/09/06 2006/09/06 2006/09/06 2006/09/06 2006/09/06 2006/09/06 2006/09/06 2006/09/06 2006/09/06 2006/09/06 2006/09/07 2006/09/08 2006/09/08 2006/09/08 2006/09/08 2006/09/08 Direct Health Ltd. Boston Scientific H. K. Ltd. Baxter Healthcare Ltd. N/A Dade Behring Hong Kong Ltd N/A Science International Corporation N/A N/A N/A Becton Dickinson Asia Ltd. Bayer Healthcare Ltd. (Hong Kong) Evergreen Health Care Ltd. Bayer Healthcare Ltd. (Hong Kong) N/A Siemens Ltd. Johnson & Johnson Medical Hong Kong Boston Scientific H. K. Ltd. N/A Roche Diagnostics (Hong Kong) Limited N/A N/A Agent Contact Telephone No. 2724 2836 2992 0968 2738 6080 2645 8703 N/A 2356 7033 2528 1109 2960 7117 2807 8556 N/A 2803 0118 N/A 2543 7442 N/A N/A N/A 2575 8668 2814 4829 2893 0694 2814 4829 N/A 2870 7533 2738 6080 2960 7117 N/A 2485 7555 N/A N/A The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. 2 affected units in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed all the affected users. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. 3 affected units were distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. Remarks The local agent informed all the affected users.
SA060182 Delphi IVantage Volumetric Ambulatory Infusion Pump/System SA060183 BD Unopette System Tests for Erythrocyte Fragility Test Kit, catalog # 365830 Bayer Healthcare ADVIA 1650, 1200 and 2400 Chemistry SA060184 Systems, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests Pointe Scientific AutoHDL Cholesterol Reagent Sets, various SA060185 models Bayer Healthcare RapidLab 1200 Systems, models 1245 and SA060186 1265 - blood gases, electrolyte and blood pH test systems
SA060187 ELLA Esophageal Stent - Boubella-E, Boubella, Flexella SA060188 Siemens Medical Solutions Siregraph CF Codman CSF External Drainage System III, 82-1731(EDS III SA060189 without ventricular Catheter), Lot Nos.: CGHBGF, CGGCT5, CGGCT8, CGGCT9 SA060190 Lumenis DuoTome SideLite 550 Micron Delivery System SA060191 Penlon Sigma Delta Sevoflurane Vaporizer SA060192 Roche Diagnostics Elecsys Folate II assay on the Elecsys 2010 system
SA060193 Sorin Group S5 Heart Lung Machine SA060194 Intavent Orthofix Laryngeal mask airway
Medical Device Control Office
133
Department of Health The Government of HKSAR
Respironics NICO model 7300 Cardiopulmonary Management Celki Medical System - serial numbers beginning with 138Company Applied Medical Technology Endovive Enteral Feeding Device, Boston Scientific H. K. SA060196 lot/batch number 6040734 Ltd. Boston Scientific H. K. SA060197 Boston Scientific NAMIC Fluid Injection Line, batch/lot 2011867 Ltd. Radiometer America D826 Accessory kit for single tcpO2 SA060198 Electrodes for use with the TCM400 Transcutaneous Monitor FDA (Cutaneous Oxygen Monitor) Part Number: 904-308 Zimmer VERSYS, MAYO and ZMR Hip Prosthesis Systems SA060199 FDA Femoral Stem and Body, various sizes SA060195 SA060200 AGA Medical Amplatzer VSD Occluder SA060159 SA060160 SA060201 SA060202 SA060203 Stryker Biotech Calstrux, model or catalog # 400-05CN, 40010CN and 400-15CN Datex-Ohmeda Aisys Carestation, model or catalog # 10119000-000 Draeger Medical Infant Care Isolette C2000 Incubators, model or catalog # C2HS Baxter Healthcare Continu-Flo Sets With Check Valve, various models or catalog numbers AMG Medical IV Pole, model or catalog number 775-855P and 775-860 MHRA Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada MHRA FDA FDA FDA FDA FDA MHRA FDA MHRA MHRA MHRA MHRA MHRA Boston Scientific H. K. Ltd. MHRA FDA FDA
N/A N/A N/A Z-1436-06 Z-1467-06 to Z-1480-06 2006/007/017/291/008 32208 32272 32198 32241 32257 32134 32268 MDA/2006/054 Z-1461-06 to Z-1463-06 Z-1487-06 Z-1496-06 & Z-1497-06 Z-1498-06 Z-1500-06 & Z-1501-06 2006/009/019/181/008 Z-1503-06 2006/009/015/131/001 2005/007/018/291/018 2005/007/018/291/018 2006/009/020/291/027 2006/009/022/291/010 N/A 2006/009/011/601/207 Z-1304-06 Z-1505-06
Important Medical Device Recall Notification Urgent Medical Device Recall Urgent Medical Device Recall Class II Recall Class II Recall Field Safety Corrective Action Type I Recall Type I Recall Type II Recall Type II Recall Type II Recall Type II Recall Type II Recall Immediate Action Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Field Safety Corrective Action Class II Recall Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Urgent Medical Device Recall Field Safety Corrective Action Class II Recall Class II Recall
2006/09/09 2006/09/12 2006/09/12 2006/09/13 2006/09/13 2006/09/14 2006/09/18 2006/09/18 2006/09/18 2006/09/18 2006/09/18 2006/09/18 2006/09/18 2006/09/18 2006/09/20 2006/09/20 2006/09/20 2006/09/20 2006/09/20 2006/09/20 2006/09/22 2006/09/22 2006/09/22 2006/09/22 2006/09/22 2006/09/25 2006/09/26 2006/09/26 2006/09/27 2006/09/27
Celki Medical Company Boston Scientific H. K. Ltd. Boston Scientific H. K. Ltd. N/A Zimmer PTE Ltd. (Hong Kong branch) Beijing Since Medical Scientific Co. Ltd. Stryker Hong Kong Hong Kong Oxygen & Acetylene Co. Ltd. Draeger Medical Hong Kong Ltd. Baxter Healthcare Ltd. N/A Agfa Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. Johnson & Johnson Medical Hong Kong Becton Dickinson Asia Ltd. Philips Electronics Hong Kong Ltd. N/A Mekim Ltd. N/A N/A (1) Solar-Med Ltd; (2) Goodman Medical Supplies Ltd. Smith & Nephew Healthcare Ltd. N/A N/A Smith & Nephew Healthcare Ltd. Johnson & Johnson Medical Hong Kong Boston Scientific H. K. Ltd. N/A GE Medical Systems Hong Kong Ltd. Becton Dickinson Asia Ltd.
2268 9258 2960 7117 2960 7117 N/A 2992 0968 9262 1527 2518 6915 2666 1942 2877 3077 2807 8556 N/A 2873 9336 2783 1838 2738 2818 2575 8668 2876 7525 N/A
2 affected units in Hong Kong. Rectification programme has been completed. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent will inform all the future users about the concerned issue. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed all the affected users. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong.
SA060204 AGFA IMPAX 5.2 System, model or catalog # IMPAX MA3000 SA060205 GE OEC Medical Systems OEC Mini 6800 C-ARM, various lot or serial numbers
SA060161 Lifescan OneTouch Ultra 2 Blood Glucose Meters BD Vacutainer Blood Collection Assembly with BD Blunt Plastic Cannula, Vacutainer Luer Adapter and Direct Draw Adapters Philips Medical Systems IntelliVue MultiMeasurement Server SA060207 (MMS)/Multimeasurement Server, physiological patient monitoring system. Model: M3001A Skytron General Purpose Surgical Table, Models 6600 and SA060208 6600B (battery model) SA060206 SA060209 Greiner bio-one Vacuette Tube, Item # 454332, lot # B050609 SA060210 Xiros Plc Neoligaments 6mm and 8mm Staple Impactors SA060162 Ansell Ltd. Microtouch Ultra PF Examination gloves SA060211 Hill-Rom Affinity Three Birthing Bed, Model P3700 Smith and Nephew Genesis II Non-porous fin Stem Tibial SA060212 Punches, Codes 711440480, 71440482, 71440484 and 71440486 SA060213 Huntleigh birthing beds, Models 35000 and 170000 SA060214 Hoskins Lifecare birthing beds- Models L05 an dL10 SA060215 Smith and Nephew TC100 2.7mm Cortical Bone Screws Biosense Webster Europe RefStart Catheter with QwikPatch External Reference Patch Boston Scientific Flexima all purpose drainage catheters, lot SA060217 number 8955327 SA060216 SA060218 Eschmann Equipment Ltd. Narrow Split Plate Connector GE Precision 500D Radiographic and Fluoroscopic Imaging SA060219 System, all serial numbers BD BBL Staphyloslide Latex Test Kit, Catalog # 240952 and SA060220 240953
The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. 64 affected units in Hong Kong.
The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been 2774 8339 distributed in Hong Kong. The manufacturer informed that no affected units had been N/A distributed in Hong Kong. The manufacturer informed that no affected units had been N/A distributed in Hong Kong. (1) 2425 0926; (2) 2332 15 affected units in Hong Kong. Rectification programme 4455 completed. 2645 8703 N/A N/A 2645 8703 2738 2818 2960 7117 N/A 2783 1838 2575 8668 The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. 1 affected unit in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong.
Medical Device Control Office
134
Department of Health The Government of HKSAR
SA060221 Conmed System 2500 and 5000 Electrosurgical Units Invacare Solara 2G, Spree GT and Spree XT (SPRXT) manual SA060222 wheelchairs SA060223 Stryker Power-Pro Powered Ambulance Cot, Model 6500 SA060224 SA060225 SA060226 SA060227 SA060228 SA060229 SA060230 SA060231
FDA FDA FDA
Z-1507-06 & Z-1508-06 Z-1509-06 to Z-1511-06 Z-1513-06 Z-1521-06 2006/009/022/291/004 2006/009/005/601/267 2006/009/025/291/001 N/A N/A 2006/009/027/601/314 2006/008/025/601/253 MDA/2006/056 N/A N/A 2006/009/019/181/006 2006/009/019/181/004 2006/009/004/291/006 2006/009/025/401/010 N/A
Class II Recall Class II Recall Class II Recall Class II Recall Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Urgent Medical Device Recall Worldwide Medical Device Recall Field Safety Corrective Action Field Safety Corrective Action Action Market Withdrawal Voluntary Limited Market Recall Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Press Release
2006/09/27 2006/09/27 2006/09/27 2006/09/27 2006/09/27 2006/09/27 2006/09/27 2006/09/28 2006/09/28 2006/09/28 2006/09/28 2006/09/28 2006/09/28 2006/09/28 2006/09/29 2006/09/29 2006/09/29 2006/09/29 2006/09/29
N/A Direct Health Ltd. Stryker Hong Kong N/A Beckman Coulter Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. Smiths Medical (S.E. Asia) Ltd. Boston Scientific H. K. Ltd. Becton Dickinson Asia Ltd. Abbott Laboratories Ltd. Abbott Laboratories Ltd. N/A Pacific Medical (HK) Ltd. AMO Asia Limited N/A N/A N/A N/A Johnson & Johnson Medical Hong Kong
N/A 2528 1109 2518 6915 N/A 2240 6260 2783 1838 2317 0988 2960 7117 2575 8668 2806 4841 2806 4841 N/A 2343 8009 2401 5861 N/A N/A N/A N/A 2735 8262
Kerr Optibond Solo Plus Self-Etch Adhesive System, Part FDA Number 31966 Beckman Coulter LH700 series Hematology Analyzers 2B3 2B4 MHRA and 2B5 Software GE Healthcare Technologies Gas absorbers Compact Absorber MHRA 427002000 Smiths Medical Chest Drain - Portex Chest Drainage System MHRA with Adjustable Straw - 2000ml Boston Scientific Vaxcel Implantable Chest Ports with PASV Boston Scientific H. K. Valve Technology, specific lots Ltd. BD Tube, 14mL 17x100mm PS W/SN CAP 25/PAC, lot # Becton Dickinson 6152968 and BD Procount (IVD), lot # 340398 Asia Ltd. Abbott Laboratories FSH calibrator and AsSY Master calibrator MHRA batches Abbott Laboratories CELL-DYN Sapphire List Number 08H00MHRA 01 MHRA CryoCath Technologies, Inc. Advanced Medical Optics, Inc. MHRA MHRA MHRA MHRA LifeScan Inc.
The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong.
The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed all the affected users. The local agent informed all the affected users. Superseded by MDA/2006/060. The local agent informed all the affected users. The local agent informed that no affected units had been distributed in Hong Kong.
SA060163 Sunrise Medical Jay J2, Wheelchair back CryoCath Arctic Circler Curvilinear Cardiac Cryoablation SA060164 Catheters, catalog nos. 2AC20, 2AC22, 2AC24, 2AC26 and 2AC30 AMO COMPLETE Amino Moist Multi-Purpose Solution, 360mL SA060165 x 2, lot numbers ZB02542, ZB02563, ZB02567 and ZB02575 Coloplast Drainage bag - 5062 - Conveen Urine Bag, 1500ml, SA060232 90cm tube SA060233 Micrus Endovascular Watusi Guide Wire System Hill-Rom Dynamis LI140, I148, LI150; Gerialit LI114, LI1245, SA060234 LI146, LI163 SA060235 Sendal S.A/Arcomedical Infusion Ltd, Volumed 310PK2J LifeScan Inc. SureStep Pro (part #010-797, lot #2634187008) SA060238 and OneTouch SureStep (part #020-052, lot #2627353) Blood Glucose Test Strips
The manufacturer informed that no affected units had been distributed in Hong Kong.
The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong.
Medical Device Control Office
135
Department of Health The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - August 2006
Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. Description of Product Source of Reference No. by Source Alert Type by Source Date of Issue Local Agent (YYYY/MM/DD) No. Information Field Safety Corrective SA060070 Biotronik - Stratos LV-T Pacemaker MHRA 2006/007/027/291/016 2006/08/01 N/A Action Dade Behring N Rheumatology Standard SL for RF, N/T Field Safety Corrective SA060071 MHRA 2006/006/026/131/002 2006/08/01 Dade Behring Hong Kong Ltd Rheumatology Control SL/1 and SL/2 for RF on BN System Action Becton Dickinson Vacutainer Direct Draw adaptor product code SA060072 MHRA MDA/2006/043 Action 2006/08/02 Becton Dickinson Asia Ltd. 364896 and Vacutainer Luer adaptor product code 367300 SA060073 AFOS Ltd. Endoscope storage facility (ESF) SA060074 SA060075 SA060076 SA060077 SA060078 SCC Soft Computer SoftPath ASXII Software Releases 2.3.0 and 4.3.7 SCC Soft Computer SoftPath ASCII Software, Releases 1.2, 2.1, and 2.3 Brainlab ExacTrac Robotics for installation on the Varian Exact Couch, a component of the Novalis Shaped Beam Surgery System St. Francis Medical Technologies brand X STOP® Interspinous Process Decompression (IPD) System Radiometer America Waste tubing, Model # 842-326 (pump tube for waste) and Model # 842-327 (pump tube for solution) MHRA FDA FDA FDA FDA FDA FDA FDA MDA/2006/044 Z-1243-06 Z-1252-06 Z-1255-06 Z-1258-06 Z-1260-06 Z-1261-06 Z-1262-06 Z-1263-06 to Z-1265-06 Z-1266-06 & Z-1267-06 Z-1268-06 to Z-1270-06 Z-1271-06 to Z-1285-06 N/A 2006/007/031/601/190 2006/007/003/291/017 2006/008/001/601/092 2006/007/031/081/009 30936 31533 31863 31920 31981 31344 31892 2006/007/013/291/005 2006/007/031/081/001 Action Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Urgent Medical Device Recall Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Type II Recall Type II Recall Type II Recall Type II Recall Type II Recall Type I Recall Type I Recall Field Safety Corrective Action Field Safety Corrective Action 2006/08/02 2006/08/02 2006/08/02 2006/08/02 2006/08/02 2006/08/02 2006/08/02 2006/08/02 2006/08/02 2006/08/02 2006/08/02 2006/08/02 2006/08/03 2006/08/03 2006/08/03 2006/08/03 2006/08/04 2006/08/07 2006/08/07 2006/08/07 2006/08/07 2006/08/07 2006/08/07 2006/08/07 2006/08/07 2006/08/07 N/A N/A N/A Brainlab Ltd. (Hong Kong) N/A N/A N/A N/A N/A Terumo China (H.K.) Ltd. Varian Medical Systems Pacific Inc. Zimmer PTE Ltd. (Hong Kong branch) Boston Scientific H. K. Ltd. N/A Bio-Gene Technology Ltd. Abbott Laboratories Ltd. N/A N/A N/A Ultronics Enterprise Ltd. GE Medical Systems Hong Kong Ltd. N/A N/A Tyco Healthcare (HKSAR) Limited Roche Diagnostics (Hong Kong) Limited Smiths Medical (S.E. Asia) Ltd. Agent Contact Telephone No. N/A 2803 0118 2575 8668 N/A N/A N/A 2417 1881 N/A N/A N/A N/A N/A 2866 0811 2724 2836 2992 0968 2960 7117 N/A 2646 6101 2806 4841 N/A N/A N/A 2764 5208 2783 1838 N/A N/A 3157 7244 2485 7555 2317 0988 69 affected units in Hong Kong. The manufacturer informed all the affected users. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed all the affected users. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. Remarks The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed all the affected users. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong.
SA060079 Radiometer America Dri-Tex BG-OX Cartridge, Model # D7120 Radiometer America Radiance Data Management System SA060080 Software Version 2.42 (Stand-alone software package) for the Radiance STAT Analyzer Management System
SA060081 Microcuff Pediatric and Adult Endotracheal Tubes, various sizes FDA Terumo Advanced Perfusion System 4 inch diameter Roller SA060082 Pump (model 801040) and 1 Large Roller Pump (model FDA 801041) Varian Medical Systems Gamma Win software, part number SA060083 FDA GM11019110, versions up to and including 1.62 Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot, SA060084 FDA various sizes LifeCell Repliform Tissue Regeneration Matrix, catalog Boston Scientific H. K. SA060085 numbers 820241, 820245 and 820246 Ltd. SA060086 Corin Ltd. Standard Neck Modular Head 28mm the Binding Site, Freelite human kappa free kit & human SA060087 lambda free kit assays used on Hitachi & BNII instruments SA060088 Abbott Laboratories Cystic Fibrosis V3 Genotyping Assay SA060089 Technovent Optical Conformer Impression Conformer SA060090 SA060091 SA060092 SA060093 SA060094 SA060065 SA060066 Integra Neurosciences Ultrasonic surgical Aspirator System, model or catalog # 1529161 and 1529165 Tomotherapy Incorporated HI-ART System, Lot or Serial # 10009, 10037 and 10014 Medrad Neurovascular Array Coils, model or catalog # M64NVA GE Healthcare Innova 2100IQ, lot or serial # 469545BU6 and 479238BU8 Sunrise Medical CCG Joerns Ultracare Model 770 AC Powered beds, model or catalog # U770, U770-GNDAL and U770AL BHM Medical Reacher for Transportable Ceiling Lift, Model or Catalog # 700.08310 and 700.08320 Nellcor Puritan Bennett Satin-Slip Intubating Stylet, Model or Catalog # 85863, Lots beginning with 05 and 06 MHRA MHRA MHRA MHRA Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada MHRA MHRA
SA060095 Roche Diagnostics GGT/IFCC Granulate Reagent SA060096 Smiths Medical International-Custom Epidural Pack
Medical Device Control Office
136
Department of Health The Government of HKSAR
SA060097 Smiths Medical Catheter, central venous Baxter Healthcare Blood cell separator Amicus Apheresis Kit SA060098 (Lot A06C21046, A06D10088, A06D10237, A06D25060) SA060099 Medtronic Midas Rex Classic GS and Legend dissecting tools SA060100 Sedana Medical AnaConDa Anaesthetic conserving device SA060101 SA060102 SA060103 SA060104 SA060105 SA060106 Kensey Nash TriActiv ProGuard Embolic Protection System, part number 61000-01 Applied Biotech Medplus ER Drug Screen Test, Model # 5800KAB Radiometer Medical Aps Capilliary blood sample tube caps contained in safe clinitube kits CryoCath Arctic Circler curvilinear cardiac cryoablation catheters, catalog no. 2AC30 and lot nos. 50103, 50312, 50327, 50418, 00035, 00169, 00486 Therakos Therakos UVARXTS small bowl procedural kit (Catalog No. XT125). Lot nos. U706, U707, U708, U709, U710, U711 U712 DeSoutter Medical, Sagittal Blade-Opposed Tooth
MHRA MHRA MHRA MHRA FDA FDA MHRA CryoCath Technologies Ltd. MHRA MHRA MHRA MHRA Celki Medical Company MHRA Boston Scientific H. K. Ltd. MHRA FDA FDA FDA FDA FDA FDA FDA FDA MHRA MHRA Health Canada Health Canada Health Canada Health Canada
2006/007/027/291/010 2006/007/013/291/004 03a 2006/008/002/291/003 MDA/2006/045 Z-1305-06 Z-1315-06 2006/007/010/291/001 N/A 2006/008/002/601/194 2006/008/004/081/002 2006/003/001/261/001 2006/007/012/291/005 N/A 2006/007/031/081/014 N/A 2006/008/015/081/011 Z-1306-06 & Z-1307-06 Z-1224-06 Z-1311-06 Z-1312-06 Z-1317-06 & Z-1318-06 Z-1321-06 & Z-1322-06 Z-1326-06 to Z-1333-06 Z-1335-06 to Z-1351-06 2005/005/006/401/010 2006/007/010/291/007 31495 31616 32029 31805
Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Action Class II Recall Class II Recall Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Urgent Field Action Notification Field Safety Corrective Action Urgent Medical Device Recall Field Safety Corrective Action Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Field Safety Corrective Action Field Safety Corrective Action Type I Recall Type I Recall Type I Recall Type II Recall
2006/08/07 2006/08/07 2006/08/09 2006/08/09 2006/08/09 2006/08/09 2006/08/09 2006/08/10 2006/08/10 2006/08/10 2006/08/11 2006/08/11 2006/08/14 2006/08/14 2006/08/16 2006/08/16 2006/08/16 2006/08/16 2006/08/16 2006/08/16 2006/08/16 2006/08/16 2006/08/16 2006/08/16 2006/08/17 2006/08/18 2006/08/21 2006/08/21 2006/08/21 2006/08/21
Smiths Medical (S.E. Asia) Ltd. Baxter Healthcare Ltd. Medtronic International, Ltd. N/A N/A N/A N/A Pacific Medical (HK) Co. Ltd. N/A N/A N/A N/A Celki Medical Company Gambro China Ltd. Boston Scientific H. K. Ltd. N/A Abbott Laboratories Ltd. N/A N/A N/A N/A N/A N/A Zimmer PTE Ltd. (Hong Kong branch) N/A N/A Roche Diagnostics (Hong Kong) Limited Gambro China Ltd. Bio-Rad Pacific Ltd. Beckman Coulter Hong Kong Ltd.
2317 0988 2807 8556 2919 1362 N/A N/A N/A N/A 2755 6948 N/A N/A N/A N/A 2268 9228 2576 2688 2960 7117 N/A 2806 4210 N/A N/A N/A N/A N/A N/A 2992 0968 N/A N/A 2485 7510 2576 2688 2789 3300 2240 6260
The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed all the affected users. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. 7 affected units in Hong Kong.
SA060107 Days Healthcare Strider Maxi 3, Maxi 4 & Maxi 4 Plus Coloplast A/S, Simpla Al Silicone Indwelling Catheters Code: SA060108 367516 Male Ch16 Lot 696770 SA060109 Respironics Esprit Ventilator Power Supply SA060110 SA060111 SA060112 SA060113 Gambro Renal Prismaflex Continuous Renal Relacement System, Model 6023014700 Boston Scientific vanSonnenberg Sump Catheter, lot/batch number 8606405 Richard Wolf Single Use Tem Tubing Sets, Type 4170.801 Batch 060232 Abbott brand FreeStyle and FreeStyle Flash Blood Glucose Meters
The local agent informed that no affected units had been distributed in Hong Kong.
SA060114 MediSurg Fugo Blade Incising Tip Assembly SA060115 SA060116 SA060117 SA060118 SA060119 Tekia TEKLENS II (TEKIA label) and Polylens A60 (Polytech label) Model 614 intraocular lens ArthroCare OPUS Speedstitch Suture Cartridge with Magnumwire, Catalog number OM-6006 Radiometer America Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-700 and ABL-800 Series Radiometer America Capillary (end) caps, accessory for use with blood gas analyzers included in Radiometer's CLINITUBES kits, Model # 904-439 and 904-453 Pointe Scientific Liquid Glucose HEX(R1), HEX(R2), HEX and HEXO Reagents and Reagent Sets
The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. For further details, please see the website notice: http://www.mdco.gov.hk/english/recalls/recalls_20060828.htm l 2 affected units in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong.
SA060120 Zimmer sterile bone screws, various models and sizes SA060121 Edwards Lifesciences Aquarius Heamofiltration machine SA060122 Medicina Infant Feeding Tubes SA060067 Roche Diagnostics Accu-chek Advantage for Accudata GTS, Accu-Soft & Accu-Chek Advantage Blood Glucose Meters
SA060068 Gambro Prismaflex Continuous Renal Replacement System SA060123 Bio-Rad Laboratories Genetic System HIV-2 EIA, Model or Catalog # 32536, lot or serial # 032AY1 & 139AY1 Beckman Coulter FP1000 Cell Preparation System, model or SA060124 catalog # 624922
Medical Device Control Office
137
Department of Health The Government of HKSAR
SA060125
Baxter Healthcare Arena SPP and SPX Hemodialysis Delivery Systems, Hemodialysis Machine 1550, Machine 1550 Single Needle Hemodialysis and System 1000 Dialysate Delivery System, all serial numbers
Health Canada
32017
Type II Recall
2006/08/21
Baxter Healthcare Ltd.
2807 8556
The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. 1 affected unit in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. 2 affected units in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong.
SA060126 Osmetech OPTI CCA Blood Gas & Electrolyte Analyz SA060127 Smiths Medical Hotline L-10 Gas Vent SA060128 SA060129 SA060130 SA060131 SA060132 SA060133 Smith & Nephew Electroblade Resector 4.5, 4.5 Elite/FR and Trivex Resector Kit Edwards Lifesciences Vascushunt Silicone Balloon Shunt, model or catalog # T3103AS, lot or serial # 58220388 Siemens Arcadis Orbic and Arcadis Varic, model or catalog # 8081080 and 8080017 Siemens Lithoskop, model or catalog # 8355088, lot or serial # 1019 Nomos (North American Scientific) Corvus Planning System 6.0/6.1 Fujinon Mobile Endoscopy Cart, lot or serial # 125769, 125770, 125774, 125767 and 125772
Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada MHRA MHRA MHRA FDA
32028 32033 31890 32037 32040 32043 32048 31389 31875 32059 32092 2006/008/016/081/005 2006/008/015/121/002 2006/008/016/081/012 Z-1377-06 to Z-1384-06
Type II Recall Type II Recall Type II Recall Type II Recall Type II Recall Type II Recall Type II Recall Type II Recall Type II Recall Type II Recall Type II Recall Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Class II Recall
2006/08/21 2006/08/21 2006/08/21 2006/08/21 2006/08/21 2006/08/21 2006/08/21 2006/08/21 2006/08/21 2006/08/21 2006/08/21 2006/08/21 2006/08/21 2006/08/21 2006/08/22
N/A Smiths Medical (S.E. Asia) Ltd. Smith & Nephew Healthcare Ltd. N/A Siemens Ltd. Siemens Ltd. N/A Goodman Medical Supplies Ltd. Maquet Hong Kong Limited Gambro China Ltd. Siemens Ltd. Beckman Coulter Hong Kong Ltd. Bayer Healthcare Ltd. (Hong Kong) Johnson & Johnson Medical Hong Kong Roche Diagnostics (Hong Kong) Limited N/A
N/A 2317 0988 2645 8703 N/A 2870 7533 2870 7533 N/A 2332 4455 2393 9511 2576 2688 2870 7533 2240 6260 2814 4829 2738 2818 2485 7510
SA060134 Maquet Critical Care HL30 Perfusion System SA060135 Gambro Prismaflex Modele 6023014700, all serial numbers Siemens Medical Solutions Oncology Care Systems ZXT SA060136 Treatment Table, model or catalog # 9820952 and 05844621 Beckman Coulter Unicel DxI 800 Access Immunoassay System SA060137 Wash Buffer SA060138 Bayer Healthcare ADVIA Centaur CP Immunoassay Analyser Cordis Neurovascular Pre-shaped Prowler and pre-shaped SA060139 PROWLER SELECT infusion catheters Roche Diagnostics Accu-chek Comfort Curve, Advantage, SA060140 Sensor Comfort and Inform Blood Glucose Meter Test Strips Orthopaedic implants manufactured by Proconcept SA France: CIFEC cervical cages; LIFEC lumbar cagesl ALIFEC lumbar SA060141 cages; SRE/SEO spinal screw systems; CANALETTO carpal tunnel protection implants SA060142 Maquet Critical Care AB Heart Lung Machines HL20 and HL30 SA060143 SA060144 SA060145 SA060146 SA060147 SA060148 SA060149 Roche Tina-Quant ASLO (Anti-streptolysin O) Reagent Kit, Catalog No. 1931601 Radiometer America Blood Gas and Co-Ox2 Electrolyte & Metabolyte Analyzers, ABL-700 and ABL-800 Series Pointe Scientific Alkaline Phosphatase reagents, buffers and substrates, various models Varian Medical Systems GammaMed software programs for the GammaMed models 12i and 12it radionuclide applicator systems Siemens LANTIS XLINK (Impac MultiAccess Sequencer) on Varian accelerators with the MLC3PI interface Baxter Intermate and Infusor Large volume (LV) infusion pumps - all models Cardinal Health Alaris SE Pump (formerly Signature Edition Infusion Pump), all models
The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. With affected units in Hong Kong.
MHRA
MDA/2006/046
Immediate Action Field Safety Corrective Action Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Action Press Release Action Field Safety Corrective Action Class II Recall Class II Recall Class II Recall
2006/08/22
N/A The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong.
MHRA FDA FDA FDA FDA FDA MHRA FDA MHRA MHRA FDA FDA FDA
2006/008/022/081/011 Z-1385-06 Z-1386-06 & Z-1387-06 Z-1388-06 to Z-1397-06 Z-1398-06 & Z-1399-06 Z-1401-06 MDA/2006/048 N/A MDA/2006/050 2006/008/021/291/006 Z-1410-06 Z-1416-06 to Z-1418-06 Z-1419-06
2006/08/23 2006/08/23 2006/08/23 2006/08/23 2006/08/23 2006/08/23 2006/08/24 2006/08/28 2006/08/29 2006/08/30 2006/08/30 2006/08/30 2006/08/30
Maquet Hong Kong Limited Roche Diagnostics (Hong Kong) Limited N/A Evergreen Health Care Ltd. Varian Medical Systems Pacific Inc. Siemens Ltd. Baxter Healthcare Ltd. The Vita Company Ltd. N/A B. Braun Medical (Hong Kong) Ltd. Hong Kong Oxygen & Acetylene Co. Ltd. Zimmer PTE Ltd. (Hong Kong branch) N/A
2393 9511 2485 7555 N/A 2893 0694 2724 2836 2870 7533 2807 8556 2548 7483 N/A 2277 6125 2666 1942 2992 0968 N/A
SA060150 Chiltern Invadex ceiling track patient hoists with turntables SA060151 B Braun Aesculap NC 464T and NC468T Acetabular cups INO Therapeutics (Datex Ohmeda) INOvent Nitric Oxide Delivery System, Model Number 1605-9000-000 Zimmer Trabecular Metal Reverse Shoulder System SA060153 Glenosphere and Base Plate BioCare Systems LumiWave 1X4 Infrared Therapy Device, SA060154 Catalog # LW1X4 SA060152
Medical Device Control Office
138
Department of Health The Government of HKSAR
A & E Industries Guardian Walker and Guardian 5 inch Walker Wheel Kits, various models Cobe Optima XP Hollow Fiber, CML Duo Flat Sheet and SA060156 Optimin Hollow Fiber Sealed System Membrane Oxygenators/Reservoirs, various models MicroVision Medical MicroScan Lens Disposable Plastic Cap SA060157 used with MicroScan Video Microscope SA060155 SA060069 Medtronic LIFEPAK 20 Defibrillator/Monitors SA060158 Abbott Laboratories Xsystems CA 15-3 controls
FDA FDA FDA Medtronic International, Ltd. MHRA
Z-1420-06 & Z-1421-06 Z-1422-06 to Z-1429-06 Z-1435-06 N/A 2006/008/023/291/007
Class II Recall Class II Recall Class II Recall Urgent Medical Device Correction Field Safety Corrective Action
2006/08/30 2006/08/30 2006/08/30 2006/08/31 2006/08/31
N/A N/A N/A Medtronic International, Ltd. Abbott Laboratories Ltd.
N/A N/A N/A 2919 1362 2806 4841
The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. 5 affected units in Hong Kong. Rectification completed. The manufacturer informed all the affected users.
Medical Device Control Office
139
Department of Health The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - July 2006
Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. Description of Product Source of Reference No. by Source Alert Type by Source Date of Issue Local Agent (YYYY/MM/DD) No. Information Boston Scientific Urgent Medical Device SA060001 Boston Scientific Expo and Impulse Angiographic Catheter N/A 2006/07/03 Boston Scientific Hong Kong Ltd. Hong Kong Ltd. Recall SA060002 Adept-Med brand Glassman Viscera Retainer FISH SA060003 Suros Surgical ATEC Breast Biopsy and Excision System Needle Guide, 9 GA, sterile, in packages of 5, Ref ATEC NG09 Biomerieux OBSERVA R02 (version R02.00.17) computers SA060004 using PSC 6000 or HHP Barcode Scanners connected to BacT/ALERT 3D SA060005 Leica M520 Surgical Microscope SA060006 B. Braun 9F (O/S) Locking Tearway Introducers, non-sterile, Catalog number 614008 St. Jude Medical CPS Slitter, Valve Bypass Tool (VBT), Direct SA060007 SL, Aim and Implant Kit, various models Roche Calcium Reagent Kit for use on the Cobas MIRA SA060008 Chemistry System SA060009 Welch Allyn PIC 50 external defibrillator/monitor SA060010 Boston Scientific Urovac bladder evacuator SA060011 Boston Scientific Carotid WALLSTENT endoprothesis with Monorail delivery system FDA FDA FDA FDA FDA FDA FDA FDA Boston Scientific Hong Kong Ltd. Boston Scientific Hong Kong Ltd. Health Canada Z-1156-06 Z-1160-06 Z-1161-06 Z-1162-06 Z-1163-06 Z-1164-06 to Z-1168-06 Z-1176-06 Z-1195-06 N/A N/A 31746 Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class I Recall Urgent Medical Device Recall Urgent Medical Device Recall Type II Recall 2006/07/05 2006/07/05 2006/07/05 2006/07/05 2006/07/05 2006/07/05 2006/07/05 2006/07/07 2006/07/07 2006/07/08 2006/07/10 Solar Medical Ltd. N/A BioMerieux China Limited Leica Microsystems Ltd. (Hong Kong) B. Braun Medical (Hong Kong) Ltd. St. Jude Medical (Hong Kong) Ltd. Roche Diagnostics (Hong Kong) Limited N/A Boston Scientific Hong Kong Ltd. Boston Scientific Hong Kong Ltd. Agent Contact Telephone No. 2960 7117 2425 0926 N/A 2356 7033 2564 6699 2277 6125 2996 7601 2485 7555 N/A 2960 7117 2960 7117 Remarks The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. 3 affected units in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. 35 units of the affected models previously supplied in Hong Kong. 149 affected units in Hong Kong. The local agents informed that no affected units had been distributed in Hong Kong. The local agents informed that no affected units had been distributed in Hong Kong.
SA060012 Cook Malleable Tip Filiform, model or catalog # 110245 Cook Duette Multi Band Mucosectomy Kit, model or catalog # DT-6 Beckman Coulter UniCel DxC 600, 600i and 800 Synchron SA060014 Clinical Systems, model or catalog # A20463, A27331 and A29764 Coopersurgical 60cc Handy-Vak Locking Syringe, model or SA060015 catalog # MX 500 Bio-Rad Laboratories Diagnostics Group Liquichek Pediatric SA060016 Control, model or catalog # 353X, 354 and 355 SA060013 SA060017 Plus Orthopedics Femoral Clamp TKR (slim) SA060018 SA060019 SA060020 SA060021 SA060022 SA060023 SA060024 SA060025 Gyrus ACMI PKS PlasmaSEAL Open Forceps, model 2103PK and 917015PK MDS Nordion Theratron 780C, 780E, 1000, 1000E, Phoenix, Elite 80 and Elite 100 Cobalt Radiotherapies Terang Nusa Sterile Triumph LT Latex Powder-Free Surgeons Gloves, lot number T502504322 ArthroCare OPUS Smartstitch Suture Cartridge (catalog number OM-8071) and Smartstitch Magnum Wire Suture Cartridge (catalog number OM-8075) Sorenson Medical ambIT Ambulatory Infusion Therapy Intermittent Pump, catalog number 220245 Southmedic Vapofils with Stainless Steel Block Ends, Item Numbers V0507F (Isoflurane) and V0507S (Sevofluane) Respironics NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous), model number 1025310 Spacelabs Medical 1400 MHz Telemetry System,. Model 91341-09
Health Canada Health Canada Health Canada Health Canada MHRA FDA FDA FDA FDA FDA FDA FDA FDA FDA MHRA FDA
31750 31742 30621 31622 2006/006/022/291/010 Z-1175-06 Z-1178-06 to Z-1184-06 Z-1185-06 Z-1186-06 & Z-1187-06 Z-1188-06 Z-1189-06 & Z-1190-06 Z-1191-06 Z-1202-06 Z-1205-06 2006/007/010/291/024 Z-1206-06
Type II Recall Type II Recall Type II Recall Type II Recall Field Safety Corrective Action Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Field Safety Corrective Action Class II Recall
2006/07/10 2006/07/10 2006/07/10 2006/07/10 2006/07/10 2006/07/12 2006/07/12 2006/07/12 2006/07/12 2006/07/12 2006/07/12 2006/07/12 2006/07/12 2006/07/12 2006/07/12 2006/07/12
(1) Cook Asia (Hong Kong) Ltd.; (2) (1) 2781 0232; (2) 2541 A.R. Burkhill & Sons (Hong Kong) 1041 Ltd. (1) Cook Asia (Hong Kong) Ltd.; (2) (1) 2781 0232; (2) 2541 A.R. Burkhill & Sons (Hong Kong) 1041 Ltd. Beckman Coulter Hong Kong Ltd. N/A Bio-Rad Pacific Ltd. N/A N/A MDS Nordion (Hong Kong) N/A N/A N/A N/A Celki Medical Company Suburfarm Investment & Trading Co. Ltd. Siemens Medical Solutions Ltd. N/A Varian Medical Systems Pacific Inc. 2240 6260 N/A 2789 3300 N/A N/A 2827 8666 N/A N/A N/A N/A 2268 9228 2780 9421 2870 7533 N/A 2724 2836
The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent has informed all affected users. No product recall was necessary. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. 2 affected units in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. With affected units in Hong Kong.
SA060026 Siemens 3D-I/III Ceiling Stand, Diagnostic x-ray tube mount SA060027 Cardinal Health Extension Set Model G304020M and G400200B
SA060028 Hand pendants of Varian C-Series Clinac linear accelerators
Medical Device Control Office
140
Department of Health The Government of HKSAR
SA060029
Disetronic D-TRONplus power packs used in D-TRONplus insulin pumps
FDA MHRA Boston Scientific Hong Kong Ltd. MHRA MHRA MHRA MHRA FDA FDA FDA FDA FDA FDA MHRA Medtronic International, Ltd. FDA MHRA Health Canada Health Canada Health Canada Health Canada Boston Scientific Hong Kong Ltd. FDA FDA FDA FDA FDA FDA FDA FDA MHRA MHRA
N/A 2006/007/003/291/024 N/A 2006/006/016/401/017 2006/007/003/291/014 2006/007/013/081/004 2006/007/013/291/004 Z-1196-06 Z-1207-06 to Z-1211-06 Z-1212-06 Z-1219-06 to Z-1221-06 Z-1222-06 Z-1223-06 2006/007/017/601/173 N/A N/A MDA/2006/042 28894 31477 31861 31353 N/A Z-1225-06 Z-1226-06 to Z-1229-06 Z-1230-06 to Z-1233-06 Z-1234-06 Z-1236-06 & Z-1237-06 Z-1239-06 Z-1240-06 Z-1246-06 & Z-1247-06 2006/006/029/291/002 2006/005/015/291/003
Firm Press Release Field Safety Corrective Action Urgent Medical Device Recall Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Field Safety Corrective Action Voluntary Field Corrective Action Urgent: Worldwide Medical Device Recall Action Type II Recall Type II Recall Type II Recall Type II Recall Urgent Medical Device Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Class II Recall Field Safety Corrective Action Field Safety Corrective Action
2006/07/13 2006/07/13 2006/07/14 2006/07/14 2006/07/14 2006/07/14 2006/07/17 2006/07/19 2006/07/19 2006/07/19 2006/07/19 2006/07/19 2006/07/19 2006/07/19 2006/07/19 2006/07/21 2006/07/24 2006/07/24 2006/07/24 2006/07/24 2006/07/24 2006/07/25 2006/07/26 2006/07/26 2006/07/26 2006/07/26 2006/07/26 2006/07/26 2006/07/26 2006/07/26 2006/07/26 2006/07/26
Roche Diagnostics (Hong Kong) Limited N/A Boston Scientific Hong Kong Ltd. N/A N/A N/A Baxter Healthcare Ltd. GE Medical Systems Hong Kong Ltd. N/A N/A N/A N/A N/A N/A Medtronic International, Ltd. Medtronic International, Ltd. N/A Novartis Pharmaceuticals (HK) Ltd. South East Chemicals & Instruments Ltd. Terumo China (H.K.) Ltd. N/A Boston Scientific Hong Kong Ltd. N/A Smith & Nephew Healthcare Ltd. Smith & Nephew Healthcare Ltd. 3M Hong Kong Ltd. W.L. Gore & Associates (Hong Kong) Limited N/A Johnson & Johnson (Medical) Hong Kong Ltd. Instrumentation Laboratory Ltd. Abbott Laboratories Ltd. Olympus Hong Kong Ltd.
2485 7597 N/A 2960 7117 N/A N/A N/A 2807 8556 2783 1838 N/A N/A N/A N/A N/A N/A 2919 1355 2919 1362 N/A 2881 4235 2802 6333 2866 0811 N/A 2960 7117 N/A 2645 8703 2645 8703 2806 6314 2622 9622 N/A 2738 6080 2792 7773 2806 4201 2376 1805
SA060030 Rocket Sekdubger Chest Drainage Set SA060031 EMS Swiss LithoClast Ultra ultrasound handpiece kit SA060032 Bio Stat Gentamicin Calibrator SA060033 Joint Replacement Instrumentation Ltd. Brill Bit SA060034 Wako Chemical Lp(a) Calibrator (Code No. 417-41491) Lot 52F5
SA060035 Baxter Healthcare Blood cell separator Amicus Apheresis Kit SA060036 SA060037 SA060038 SA060039 SA060040 SA060041 GE Healthcare S/5 Anesthesia Delivery Unit Fresh Gas Control (A-FGC1) Unit Sammons Preston Rolyan ValueLine and Midland Mat Platforms, various models Vanguard Medical Concepts Reprocessed Ethicon Bladeless Trocars, model 35NLT, 35NST, 35OL Kensey Nash TriActiv System Procedure Kit and Balloon Inflation Syringe International Biophysics Corporation (IBC) Suction Handle (Sterile), part # 1990S International Biophysics Corporation (IBC) FloProbe (Nonsterile), part # 3080N
SA060042 Bard 8F Bard Channel Steerable Shealth SA060043 Medtronic Model 7428 Kinetra Implantable Neurostimulator SA060044 Medtronic Model 8731 intrathecal catheters and model 8598 intrathecal catheter distal revision kits Cardinal Health (formerly known as ALARIS) IVAC P4000 SA060045 Syringe pump SA060046 CIBA Vision Clerz 15ml, lot or serial # 48329 SA060047 Oxoid Imipenem 10ug Discs Terumo Cardiovascular Systems Advanced Perfusion System 1-Centrifugal and 1-Roller Pump Bellco Formula, Formula 2000, Formula 2000 Domus, Formula SA060049 2000 Plus and Formula 2000 Plus Domus Hemodialysis SA060048 SA060050 Boston Scientific Cutting Balloon Ultra Monorail Device Teleflex Medical Green Spec Fiberoptic Laryngoscope Handle SA060051 - Stubby/Short, catalog number 004413300 SA060052 Smith & Nephew TriVex Resector Kits, various models SA060053 Smith & Nephew Dyonics Electroblade 4.5, various models SA060054 3M Nexcare First Aid High Performance Gauze Pad SA060055 Gore Tag Thoracic Endoprosthesis Systems Aksys PHD Personal Hemodialysis System for daily home SA060056 hemodialysis, Model 1M101 SA060057 Cordis INFINITI 6 French Diagnostic Catheter Instrumentation Laboratory HemosIL and Hemoliance RecombiPlasTin, Prothrombin Time Test Abbott Laboratories Murex HTLV I + II, List Number: 8E22-02, SA060059 Lot Number: J156610 and J156710 Olympus Life and Material Science Europa GmbH SA060060 Immunoglobulin M, OSR6146 SA060058
2
The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. 31 affected units in Hong Kong. Rectification completed. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. 106 units distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong.
The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong.
The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong.
Medical Device Control Office
141
Department of Health The Government of HKSAR
SA060061
Cordis SV-5 and SV-8 Peripheral Steerable Guidewires Catalog 503-558, 503-558X, 503-658, 503-658X (41 specific lots only) Baxa Ltd. Reusable enteral feeding dispenser 50ml for SA060062 attachement to female oral ports Potasium electrode for Roche Hitachi 917 Modular Analytics, SA060063 Lot number L33 and L99 and all M lots Beckman Coulter Cytomics FC 500 Flow Cytometers System SA060064 with CXP Software versions: 2.0 and 2.1
MHRA MHRA MHRA MHRA
2006/007/026/081/004 2006/007/025/291/014 2006/007/021/081/003 2006/007/028/291/004
Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action
2006/07/27 2006/07/27 2006/07/31 2006/07/31
Johnson & Johnson Medical Hong Kong N/A Roche Diagnostics (Hong Kong) Limited Beckman Coulter Hong Kong Ltd.
2738 6080 N/A 2485 7597 2240 6260
The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. With affected units in Hong Kong.
Medical Device Control Office
142
Department of Health The Government of HKSAR

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