Monthly Summary of Medical Device Safety Alerts

Monthly Summary of Medical Device Safety Alerts - July 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 Source of Date of Issue Description of Product Reference No. by Source Alert Type by Source Local Agent Information* (YYYY/MM/DD) Siemens E.CAM Patient Handling System (PHS) Field of View (FOV) Siemens Healthcare FDA Z-1505-2009 Class II 2-Jul-09 indicator bars (Part no 43 66 618 and 43 81 088) Diagnostic Limited Z-1471-2009 to Z-1473Arrow Embolectomy Catheters Class II 2-Jul-09 Cemma Enterprise Co., Ltd FDA 2009 Inverness Medical BioSrar Strep A OIA MAX (Product Code 90003) Z-1506-2009 Class II 2-Jul-09 N.A. FDA Edwards LifeSciences BM25 2009/006/018/081/010 FSN 2-Jul-09 N.A. MHRA GE Medical Systems Hong GE CT Perfusion 4 MHRA 2009/003/019/061/005 FSN 2-Jul-09 Kong Ltd. Cardinal Health Alaris GP volumetric pump and Alaris GP Guardrails MHRA 2009/006/017/291/018 FSN 2-Jul-09 Cardinal Health volumetric pump Bausch & Lomb Firm Initiated Field Bausch & Lomb (Hong Kong Bausch & Lomb Boston Conditioning Solution Original Formula N.A. 2-Jul-09 (Hong Kong ) Ltd Action ) Ltd Agfa NX software 2009/006/029/081/013 FSN 6-Jul-09 AGFA Hong Kong Limited MHRA Edwards Lifesciences Fogarty Occlusion Catheter 2009/006/026/081/006 FSN 6-Jul-09 N.A. MHRA GE Medical Systems Hong GE Signa Excite 1.5T MR systems MHRA 2009/006/024/291/013 FSN 6-Jul-09 Kong Ltd. Solutions Health Care Likoscale Adaptor 2009/006/022/301/001 FSN 6-Jul-09 MHRA Products Karomed COMM-METAL Supreme Profiling Bed 2009/001/028/301/003 FSN 6-Jul-09 N.A. MHRA Sidhil Bradshaw Bariatric Bed 2009/006/016/261/001 FSN 6-Jul-09 N.A. MHRA Wescott Medical Sae-Flo 2009/004/014/401/004 FSN 6-Jul-09 N.A. MHRA Philips Dental Application v4.0.0 to v4.0.1.9999 on the Extended Philips Health Care (Great MHRA 2009/006/010/291/008 FSN 6-Jul-09 Brilliance Workspace China) Medtronic SynchroMed II (Model 8637) Implantable Drug Infusion Pump Medtronic Firm Initiated Field N.A. 6-Jul-09 Medtronic International Ltd. Battery Performance International Ltd. Action Philips Health Care (Great Philips Intellivue MP70 Patient Monitor System (Model # M8007A) Health Canada 48839 Type II 7-Jul-09 China) Philips Mulitdiagnost Eleva-Flat Detector and Allura XPER FD10/10-Main Philips Health Care (Great Health Canada 48595 Type II 7-Jul-09 Unit China) Philips Achieve 3.0T MRI System-Main Unit and Achieva 1.5T MRI Philips Health Care (Great Health Canada 49149 Type II 7-Jul-09 System-Main Unit China) Philips Health Care (Great Philips Brilliance 6/10/16 Slice CT-SERTWR Dent Health Canada 49151 Type II 7-Jul-09 China) Zimmer PTE Ltd. (Hong Zimmer ZMR Hip System-Stems Health Canada 48913 Type II 7-Jul-09 Kong branch) Zimmer PTE Ltd. (Hong Zimmer Alumina Ceramic Femoral Head Health Canada 48988 Type II 7-Jul-09 Kong branch) Zimmer PTE Ltd. (Hong Zimmer 2.7mm Cortical Screw Self-Tapping Health Canada 48914 Type II 7-Jul-09 Kong branch) Smith & Nephew Disposable Endoscopic Surgery Blades 48408 Type II 7-Jul-09 Smith & Nephew LTD Health Canada GE Medical Systems Hong GE Muse Cardiology Information System Health Canada 46833 Type II 7-Jul-09 Kong Ltd. GE Medical Systems Hong GE Carescape V100 Health Canada 46236 Type II 7-Jul-09 Kong Ltd. Varian Medical Systems Varian Aria Radiation Oncology Health Canada 49074 Type II 7-Jul-09 Pacific Inc. Getinge Washer Disinfectors with transformer 48035 Type II 7-Jul-09 N.A. Health Canada Data Innovations Instrument Manager 48997 Type II 7-Jul-09 N.A. Health Canada Picis OR Manager, Preop Manager, Anesthesia Manager, PACU Health Canada 48937 Type II 7-Jul-09 N.A. Manager, Critical Care Manager Boston Scientific Firm Initiated Field Boston Scientific Hong Kong Boston Scientific Flexima Biliary Catheter System N.A. 8-Jul-09 Hong Kong Ltd Action Ltd

Medical Device Control Office

1

Department of Health The Government of HKSAR

Respironics BiPAP Focus Noninvasive Ventilator System Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate (Model no. 6420-00-002, 6420-01-002, 6420-00-200, 6420-01-200)

FDA

Zimmer Steinmann Pins (Model no. 00-0187-03-69)

FDA

Zimmer Gender Solutions Natural Knee Flex System (Product No. 005410-017-01)

Class I

9-Jul-09

Class II

9-Jul-09

Z-1481-2009

Class II

9-Jul-09

FDA

Z-1477-2009

Class II

9-Jul-09

Philips Brilliance iCT software v2.5.0 (Model 728306)

FDA

Z-1582-2009

Class II

9-Jul-09

GE Centricity PACS Software

FDA

Z-1549-2009

Class II

9-Jul-09

FDA

Z-1474-2009 to Z-14762009

Class II

9-Jul-09

GE Medical Systems Hong Kong Ltd.

Class II

9-Jul-09

Stryker China Ltd

Class II

9-Jul-09

N.A.

FDA FDA FDA

Z-1525-2009 Z-1526-2009 to Z-15312009 Z-1539-2009 Z-1489-2009 to Z-15032009 Z-1524-2009

Class II Class II Class II

9-Jul-09 9-Jul-09 9-Jul-09

N.A. N.A. N.A.

FDA

Z-1247-2009

Class II

9-Jul-09

N.A.

BD

N.A.

Firm Initiated Field Action

9-Jul-09

BD

MHRA

MDA/2009/043

MDA

10-Jul-09

Boston Scientific Hong Kong Ltd

10-Jul-09

Medtronic International Ltd.

10-Jul-09


GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System; Innova 3100/3100IQ Cardiovascular Imaging System and Innova 4100/4100IQ Cardiovascular Imaging System Stryker Xia Dual Anterior Staple (Catalog no. 03820115) Biomet OSS FINN Proximal Femoral Trial, OSS Letson Proximal Femoral Trial, OSS Elliptical Proximal Femoral Tral Bard StartLock Intravenous (IV) Catheter Stabilization Kit (Catalog no IVK0124) Arrow various devices Ascension Normed TX8 Driver (Catalog no 503004268) Del Medical Systems Ceiling Tube Mount (CTM) / Digital Ceiling Tube Mount (DCTM) 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 Zimmer Intertrochanteric / Subtrochanteric Fixation Tapered Reamer 002258-050-00 Smith & Nephew Disposable Impactor Cap 74120152 for use with BHR Acetabular Cups Aidapt VB539 Solo Deluxe Shower Seat and VB535 Solo Deluxe Shower Seat with Pads Unipath Clearview hCG Pregnancy Test 506788

FDA

FDA FDA

Medtronic International Ltd. Medtronic International Ltd. Boston Scientific Hong Kong Ltd

Z-1606-2009 Z-1482-2009 to Z-14852009

Firm Initiated Field Action Firm Initiated Field Action Firm Initiated Field Action

N.A. N.A. N.A.

10-Jul-09

Celki Medical Company Zimmer PTE Ltd. (Hong Kong branch) Zimmer PTE Ltd. (Hong Kong branch) Zimmer PTE Ltd. (Hong Kong branch) Philips Health Care (Great China) GE Medical Systems Hong Kong Ltd.

Boston Scientific Hong Kong Ltd Zimmer PTE Ltd. (Hong Kong branch)

MHRA

2009/006/008/291/011

FSN

13-Jul-09

MHRA

2009/006/019/601/002

FSN

13-Jul-09

Smith & Nephew LTD

MHRA

2009/006/029/261/001

FSN

13-Jul-09

N.A.

MHRA

2009/005/011/291/018

FSN

13-Jul-09

Zimmer Dynesys Top Loading Spacer Cutter

MHRA

2009/006/018/291/006

FSN

13-Jul-09

Microm (a part of ThermoFisher Scientific) STP 420D Tissue Processor Biodiagnostics MPO QuickCard Nopac Healthcare Chelmer 200

MHRA MHRA MHRA

2009/006/023/291/002 2009/006/023/601/001 2009/006/002/301/001

FSN FSN FSN

13-Jul-09 13-Jul-09 14-Jul-09

Siemens Stratus CS Acute Care Troponin I CalPak.

FDA

Class II

20-Jul-09

Genicon Suction irrigation device (Cat no. 700-005-010, 700-010-005) Del Medical Systems Ceiling Tube Mount (CTM) / Digital Ceiling Tube Mount (DTCM) RSW International First Steps medicine feeder Vital Signs Broselow / Hinkle Pediatric Emergency System Intraosseus Modules Aqua Joy Premier Plus and Junior Plus bathlifts Zimmer Nexgen Rotating Hinge Knee-Femoral Component and Nexgen Rotating Hinge Knee-Tibial Component

FDA

Class II

20-Jul-09

FDA

Z-1246-2009 Z-1406-2009 to Z-14072009 Z-1247-2009

N.A. Zimmer PTE Ltd. (Hong Kong branch) N.A. N.A. N.A. Siemens Healthcare Diagnostic Limited N.A.

Class II

20-Jul-09

N.A.

MHRA MHRA MHRA

MDA/2009/045 2009/007/006/081/012 2008/005/007/401/005

MDA FSN FSN

21-Jul-09 21-Jul-09 21-Jul-09

Health Canada

49105

Type II

22-Jul-09

N.A. N.A. N.A. Zimmer PTE Ltd. (Hong Kong branch)


2


Health Canada

48344

Type II

22-Jul-09

Baxter Healthcare Ltd

Health Canada

48497

Type II

22-Jul-09

Abbott Laboratories LTD.

Health Canada

47235

Type II

22-Jul-09

BrainLAB Ltd

Health Canada

49192

Type II

22-Jul-09

N.A.

Health Canada

48621

Type II

22-Jul-09

Nobel Biocare Asia Ltd

Health Canada Health Canada

49146 48607

Type II Type II

22-Jul-09 22-Jul-09

Health Canada

49030

Type II

22-Jul-09

MHRA MHRA MHRA MHRA

2009/007/010/601/002 2009/007/010/081/010 2009/003/010/291/010 2009/006/019/601/003

FSN FSN FSN FSN

22-Jul-09 22-Jul-09 22-Jul-09 22-Jul-09

N.A. N.A. Olympus Hong Kong and China Ltd N.A. N.A. N.A. N.A.

MHRA

2009/006/025/081/008

FSN

22-Jul-09

N.A.

FDA

Z-1555-2009

Class II

23-Jul-09

Siemens Healthcare Diagnostic Limited

FDA

Z-1550-2009 to Z-15522009

Class II

23-Jul-09

Medtronic Internation Ltd

FDA

Z-1543-2009

Class II

23-Jul-09

FDA

Z-1542-2009

Class II

23-Jul-09

FDA

Z-1570-2009

Class II

23-Jul-09

FDA FDA

Z-1245-2009 Z-1548-2009

Class II Class II

23-Jul-09 23-Jul-09

GE Medical Systems Hong Kong Ltd. Philips Health Care (Great China) Johnson & Johnson Hong Kong Ltd N.A. N.A.

FDA

Z-1554-2009

Class II

23-Jul-09

N.A.

MHRA MHRA MHRA MHRA Boston Scientific Hong Kong Ltd Health Canada

2009/007/017/081/002 2009/007/003/081/001 2009/007/006/601/008 2009/007/006/081/011

23-Jul-09 24-Jul-09 24-Jul-09 24-Jul-09

49172

FSN FSN FSN FSN Firm Initiated Field Action Type II

27-Jul-09

Ositek (Hong Kong) Inc. Ltd N.A. N.A. N.A. Boston Scientific Hong Kong Ltd Stryker China Ltd

Health Canada

49278

Type II

27-Jul-09

Stryker China Ltd

Health Canada

49199

Type II

27-Jul-09

Stryker China Ltd

Health Canada Health Canada Health Canada Health Canada

49269 49201 49177 49557

Type II Type II Type II Type II

27-Jul-09 27-Jul-09 27-Jul-09 27-Jul-09

Toshiba Digical Radiography Imaging System (Model# TFD-3000A1/WV)

Health Canada

49202

Type II

27-Jul-09

Zimmer Coonrad/Morrey Total Elbow System (Model # 32-8105-038-00; Lot# 61249897, 61249899)

Health Canada

49362

Type II

27-Jul-09

Roche Amplilink Software v 3.1.1, v 3.1.2, v3.2, v3.2.1, v3.2.2

Health Canada

48878

Type II

27-Jul-09

Stryker China Ltd Smith & Nephew LTD Smith & Nephew LTD Smith & Nephew LTD Sanko Medical Systems (HK) LTD Zimmer PTE Ltd. (Hong Kong branch) Roche Diagnostics (Hong Kong) Ltd

Cardiac Science Quinton QStress TM55 Stress Treadmill (Serial # 11040079567, 11040079568)

Health Canada

49032

Type II

27-Jul-09

Baxter Isolex 300 and 300I Magnetic Cell Separator Abbott Stat G3+ Cartridges (Model no.: 06F03-01 and 06F03-02; Lot: P08321C) Brainlab M3 Micro-MLC for Varian with MLC (Model: 41600-3, 41600-5, 41600-6) Litecure LCT-1000 Therapy Laser Nobel Biocare Impression Coping Closed Tray Regular Platform 05x9mm (Lot 687218) Hill-Rom Flexicair (Model I3000, M4000) Wallac Delfia Xpress PAPP-A Kit (Model no. 6003-0020) Gyrus Acmi (Olympus) Sur-Catch No Tip Nitinol Stone Basket (Model no. 5711222) Vygon Neonatal / Paediatric 96 hour I.V. Filter 0807.204 Penumbra Neuron Delivery Catheter 053 Elekta Desktop Pro Bemis Quick Fit 3000cc Suction Liner Medos Medizintechnik Hilite Oxygenators (models 7000, 7000LT, 2800, 2400LT, 1000 & 800LT) Siemens Stratus CS Acute Care Troponin I CalPak Medtronic One Source Pack, One Source Pack Magellan and Ideal MAXPAC Total System GE Centricity PACS RA 1000 Workstation software (for diagnostic image analysis) Philips TumorLoc Software for the Brilliance Big Bore (BB) and the CT Extended Brilliance Workstation (EBW) (Model # 4550 116 02431) Johnson & Johnson Sterrad 50 Sterilizer (Product Code 10050) Sybaritic Hydration Station with Pedestal (Part # E30003-01 and E3000301D) Gendex VixWin Platinum Imaging Software, versions 1.0, 1.1 and 1.2 Radiometer Waste bottles Part No/Article no. a) 905-590/D512 and b) 905-802/D513 Biomet 3i ACT3020 Twist Drills One Lambda Flow Class I and Flow Class II Positive Control Serum Oxoid Oxidase Identification Sticks BR0064A Intuitive Surgical Da Vinci S Surgical System Boston Scientific Prolieve Thermodilatation System Kit Stryker E-Cylinder Canister Holder (Model# 0682-000-449, 0682-001111) Stryker Dall Miles Trochanter Cable Grip System (Model # 6704-0-210; Serial # 29233201) Stryker S3 Med/Surg Bed Fowler (Model# 302S3-000-000) and Secure II Med/Surg Bed Fowler (Model# 3002-000-000) Stryker Trident Acetabular Surgical Protocol Smith & Nephew Genesis II Femorals (Model # 71420026, Lot # 08HM17084) Smith & Nephew Exogen Bone Healing System (Model # 71034101) Smith & Nephew BHR Acetabular Cups (Model#74120152)


N.A.

3

24-Jul-09

N.A.


Advanced Bionics Removable Magnet Hires 90K (Model# CI 1400-01, CI-1400-01, CI-1400-02H)

Health Canada

49409

Type II

27-Jul-09

N.A.

27-Jul-09

Vastec Medical Limited

27-Jul-09


27-Jul-09 27-Jul-09

N.A. N.A. Philips Health Care (Great China)

Vastec Medical Limited Medtronic International Ltd. MHRA MHRA

2009/007/017/081/005 2009/007/017/081/001

Firm Initiated Field Action Firm Initiated Field Action FSN FSN

MHRA

2009/007/020/291/020

FSN

27-Jul-09

MHRA

2009/007/021/081/008

FSN

27-Jul-09

N.A.

MHRA MHRA MHRA MHRA

2009/007/021/301/001 2009/006/025/081/007 2009/007/008/081/004 MDA/2009/048

FSN FSN FSN MDA

27-Jul-09 27-Jul-09 27-Jul-09 29-Jul-09

N.A. N.A. Stryker China Ltd AGFA Hong Kong Limited

MHRA

2009/006/015/291/028

FSN

29-Jul-09

N.A.

MHRA Boston Scientific Hong Kong Ltd MHRA

2009/004/029/401/010

29-Jul-09

2009/007/010/601/001

FSN Firm Initiated Field Action FSN

Roche Diagnostics CoaguChek XS, CoaguChek XS Plus

MHRA

2009/007/016/081/002

FSN

31-Jul-09

DePuy LCS Duofix Femoral Component Trulife RM512700 extra long double adjustable soft handle elbow crutches Roche Diagnostics Factor V Leiden Kit

MHRA

2009/007/024/081/003

FSN

31-Jul-09

MHRA

2009/007/007/401/005

FSN

31-Jul-09

MHRA

2009/007/015/081/009

FSN

31-Jul-09

Maxter Cathéters Oral / enteral feeding syringe

MHRA

2009/001/016/401/004

FSN

31-Jul-09

N.A. Boston Scientific Hong Kong Ltd Abbott Laboratories LTD. Roche Diagnostics (Hong Kong) Ltd Johnson & Johnson Medical (HK) N.A. Roche Diagnostics (Hong Kong) Ltd N.A.

Trinity Biotech Mumps IgM 1 Plate (Trinity Elisa Kit Model# 2325960) Medtronic Integrated Power Console System (Ref# 1898001 & EC300) Innogenetics INNO-LIA HCV Score (product code: 80538) Innogenetics Innotest hPLAP (product code: 80326) Philips BrightView Gamma Camera Cyberonics VNS Therapy Programming Software, used with VNS Therapy Pulse and Pulse Duo Generators Mountway CU-3000 Smart Charger (for use with Neptune and Aquila) Ö ssur Icelock Expulsion Valve 551 Stryker Various titanium bone screws and modular join prostheses Agfa IMPAX 6.x when used in conjunction with TMVSE Voxar 3D 5.1. Applied Medical Resources 15x100mm Kii Optical Access System, nonthreaded Remploy Access heavy duty manual wheelchair Boston Scientific RF Ablation System Foot Switch used with EPT-1000 Cardiac Ablation Systems (Cat#840) Abbott Clinical Chemistry Total Bilirubin (List number: 6L45-20 & 6L45-40)


N.A. N.A.

N.A.

4

29-Jul-09 30-Jul-09
