Field Safety Notices
Field Safety Notice - Apr 2016
Audiences
Healthcare professional
Industry member
Product type
Medical devices
30 April 2016
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Table caption
Date of Notification | Title | FSN |
|---|---|---|
29 Apr 2016 | Cortex Screw Ø 4.5mm, self-tapping, length 20mm, Pure Titanium, Synthes GmbH (HSA 600:41/01-002/16/17_35) | |
29 Apr 2016 | AssayTip/AssayCup for MODULAR ANALYTICS E170, MODULAR ANALYTICS EVO E170, cobas e601, cobas e602, Roche Diagnostics GmbH (HSA 600:41/01-016/16/06_20) | |
28 Apr 2016 | Digital Diagnost, Philips Medical Systems (Cleveland), Inc (HSA 600:41/01-026/16/13_37) | |
27 Apr 2016 | Philips MX 16-Slice Computed Tomography X-ray System, Philips Medical Systems (Cleveland), Inc (HSA 600:41/01-026/16/12_45) | |
27 Apr 2016 | LYNOAMP BC, Sysmex Corporation (HSA 600:41/01-032/16/04_61) | |
26 Apr 2016 | ARCHITECT STAT High Sensitive Troponin-I Reagent, Abbott Ireland (HSA 600:41/01-005/16/06_24) | |
26 Apr 2016 | Insulin-Like Growth Factor (IGF-1) Assay, Siemens Healthcare Diagnostics Product Limited (HSA 600:41/01-022/16/20_60) | |
25 Apr 2016 | Biograph mCT and mCT Flow systems, Biograph TruePoint systems running PETsyngo 6.7.x software, Siemens Medical Solutions USA (HSA 600:41/01-022/16/19_25) | |
25 Apr 2016 | Ingenuity CT, Ingenuity Core, Ingenuity Core128, Brilliance 64, Brilliance iCT and Brilliance iCT SP CT systems, Philips Medical Systems (Cleveland), Inc (HSA 600:41/01-026/16/11_19) | |
22 Apr 2016 | Pump Tube, Richard Wolf GmbH (HSA 600:41/01-119/16/01_51) | |
22 Apr 2016 | Digitoxin, Roche Diagnostics GmbH (HSA 600:41/01-016/16/05_59) | |
22 Apr 2016 | Discovery IGS 730 & Discovery IGS 740 systems, GE Medical Systems SCS (HSA 600:41/01-010/16/05_08) | |
22 Apr 2016 | Aisys family of Anaesthesia devices, Datex-Ohmeda Inc (HSA 600:41/01-010/16/06_17) | |
22 Apr 2016 | REVOLUTION CT COMPUTED TOMOGRAPHY X-RAY SYSTEM, GE Healthcare (HSA 600:41/01-010/16/07_18) | |
22 Apr 2016 | Datascope Cardiosave™ Hybrid Intra-Aortic Balloon Pump (IABP) & Rescue IABP, Datascope Corp (HSA 600:41/01-017/16/02_54) | |
22 Apr 2016 | Battery Packs Used in Capnostream 20 and Capnostream 20p Patient Monitors, Medtronic Inc (HSA 600:41/01-046/16/05_48) | |
22 Apr 2016 | Image Suite 3.0 & 4.0, Carestream Health Inc (HSA 600:41/01-187/16/01_09) | |
21 Apr 2016 | Siemens RAPIDPoint® 500 System, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/16/18_58) | |
21 Apr 2016 | Ellipse™ Implantable Cardioverter Defibrillator, St Jude Medical (HSA 600:41/01-025/16/01_46) | |
21 Apr 2016 | AV-Set ONLINEplus BVM 5008-R, Fresenius Medical Care (HSA 600:41/01-062/16/01_52) | |
21 Apr 2016 | Teleflex Medical Pleur-Evac Chest Drainage Systems, Teleflex Medical (HSA 600:41/01-139/16/04_56) | |
20 Apr 2016 | Alcon LenSx Laser System, Alcon LenSx Inc (HSA 600:41/01-135/16/02_50) | |
20 Apr 2016 | ID-Papain, DiaMed GmbH (HSA 600:41/01-027/16/04_57) | |
20 Apr 2016 | CDI® Blood Parameter Monitoring System 500, BPM Sensor Head Assembly Thermistor, Terumo Cardiovascular Systems (HSA 600:41/01-028/16/03_40) | |
20 Apr 2016 | Bravo pH Monitoring System, Given Imaging Inc (HSA 600:41/01-046/16/04_36) | |
20 Apr 2016 | Bard Encor Probes, SenoRx Inc (HSA 600:41/01-050/16/04_41) | |
20 Apr 2016 | Uni-Gold LUA Plus, Trinity Biotech (HSA 600:41/01-111/16/01_34) | |
19 Apr 2016 | Arietta 60 & Arietta 70, Hitachi Aloka Medical Ltd (HSA 600:41/01-054/16/02_33) | |
19 Apr 2016 | PENTARAY® NAV Catheters, PENTARAY® NAV eco Catheters, Biosense Webster Inc (HSA 600:41/01-002/16/16_35) | |
19 Apr 2016 | cobas EGFR Mutation Test v2, Roche Diagnostics GmbH (HSA 600:41/01-016/16/04_31) | |
19 Apr 2016 | MobileDiagnost wDR2, Philips Medical Systems (HSA 600:41/01-026/16/10_37) | |
19 Apr 2016 | Leksell Gamma Knife® Perfexion™, Elekta Instrument AB (HSA 600:41/01-101/16/01_45) | |
18 Apr 2016 | BENDING/CUTTING PLIERS WITH NOSE, FOR LOCK PLATES 2.0, Synthes GmbH (HSA 600:41/01-002/16/14_19) | |
18 Apr 2016 | CIDEX Activated Glutaraldehyde Solution, Advanced Sterilization Products (HSA 600:41/01-002/16/15_54) | |
15 Apr 2016 | UniCel Coulter Cellular Analysis System - DxH 800, DxH 600, DxH Slidemaker Stainer, Beckman Coulter Inc. (HSA 600:41/01-052/16/03_22) | |
15 Apr 2016 | IRISpec CA/CB/CC, Iris International (HSA 600:41/01-052/16/04_23) | |
15 Apr 2016 | Access ClearVue™ Prone Breast device, Qfix (HSA 600:41/01-227/16/01_18) | |
14 Apr 2016 | da Vinci S Surgical System / da Vinci Si Surgical System / da Vinci Xi Surgical System, Intuitive Surgical (HSA 600:41/01-070/16/10_08) | |
14 Apr 2016 | Integra 3 Micromanipulator, Research Instruments Limited (HSA 600:41/01-210/16/01_17) | |
14 Apr 2016 | 3.5mm Locking Screws - Stardrive®, Self·Tapping & Hex Drive, Self·Tapping, Synthes GmbH (HSA 600:41/01-002/16/13_09) | |
12 Apr 2016 | Baxter Colleague CXE Volumetric Infusion Pump, Baxter Healthcare SA (HSA 600:41/01-001/16/02_46) | |
12 Apr 2016 | Lotus Valve System, Boston Scientific (HSA 600:41/01-007/16/02_48) | |
12 Apr 2016 | Hickman and Leonard Central Venous Catheter kits, Bard Access Systems, Inc. (HSA 600:41/01-050/16/03_56) | |
11 Apr 2016 | VITROS® 3600 Immunodiagnostics System & VITROS® 5600 Integrated System, Ortho-Clinical Diagnostic Inc (HSA 600:41/01-002/16/12_20) | |
08 Apr 2016 | Ossur Lil’ Angel Halo Vest, Ossur hf (HSA 600:41/01-053/16/02_43) | |
08 Apr 2016 | Miami J Cervical Collars, Ossur hf (HSA 600:41/01-053/16/01_52) | |
08 Apr 2016 | BIRMINGHAM HIP™ RESURFACING Extraction Kit (instrument), Smith & Nephew Orthopaedics (HSA 600:41/01-073/16/12_50) | |
07 Apr 2016 | CA090 Direct Drive Clip Applier, Applied Medical (HSA 600:41/01-163/16/02_41) | |
06 Apr 2016 | Ossur Miami J Cervical Collars, Ossur hf (HSA 600:41/01-294/16/02_40) | |
06 Apr 2016 | Draeger D-Vapor and D-Vapor 3000, Draeger Medical South East Asia Pte Ltd (HSA 600:41/01-063/16/01_36) | |
06 Apr 2016 | Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage & Cartilage Custom, Rebound Air Walker & Diabetic Walker, Back Support Suspenders, Extreme Custom, Unloader Custom (XT & Lite) & Custom, Ossur hf (HSA 600:41/01-294/16/01_45) | |
05 Apr 2016 | Essure ® ESS-305, Bayer Healthcare LLC (HSA 600:41/01-066/16/01_49) | |
04 Apr 2016 | LifeCycle for Prenatal Screening, Wallac Oy (HSA 600:41/01-127/16/01_59) | |
01 Apr 2016 | Philips IntelliSpace Portal software versions 5.0, 6.0, 7.0, Philips Medical Systems Nederland BV (HSA 600:41/01-026/16/08_37) | |
01 Apr 2016 | Acuson SC2000, Siemens Medical Solutions USA, Inc. (HSA 600:41/01-022/16/16_44) | |
01 Apr 2016 | SOMATOM Definition FORCE with VA50A, VA50A_SP2, Siemens Healthcare GmbH (HSA 600:41/01-022/16/15_29) | |
01 Apr 2016 | Acuson SC2000, Siemens Medical Solutions USA, Inc. (HSA 600:41/01-022/16/17_33) |