Field Safety Notices
Field Safety Notice - Apr 2015
Audiences
Healthcare professional
Industry member
Product type
Medical devices
30 April 2015
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Table caption
Date of Notification | Title | FSN |
|---|---|---|
30 Apr 2015 | Palindrome Precision SI Chronic Catheter, Palindrome SI Chronic Catheter, Palindrome Precision HSI Chronic Catheter and Palindrome HIS Chronic Catheter, Covidien llc (HSA 600:41/01-046/15/04_17) | |
30 Apr 2015 | AVEA ® ventilator, CareFusion (HSA 600:41/01-056/15/02_18) | |
30 Apr 2015 | Magellan Robotic System, Hansen Medical (HSA 600:41/01-057/15/03_09) | |
29 Apr 2015 | J&J Coated VICRYL Polyglactin 910 Absorbable Suture, Johnson & Johnson International (HSA 600:41/01-002/15/16_01) | |
29 Apr 2015 | ADVIA Chemistry Amylase Reagent, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/15/22_20) | |
29 Apr 2015 | ID-LISS/Coombs, Bio-Rad DiaMed GmbH (HSA 600:41/01-027/15/02_08) | |
28 Apr 2015 | D-Dimer Gen.2, Roche Diagnostics GmbH (HSA 600:41/01-016/15/08_16) | |
28 Apr 2015 | ExacTrac 6.x Patient Positioning System, BrainLab AG (HSA 600:41/01-047/15/02_09) | |
28 Apr 2015 | Zefon InfuseIT Disposable Pressure lnfusors, Zefon International lnc (HSA 600:41/01-051/15/01_17) | |
27 Apr 2015 | NexGen CRA/LCCK/RHK 5mm Distal Femoral Augment, Size F, Zimmer Inc (HSA 600:41/01-008/15/04_08) | |
24 Apr 2015 | Accu-Chek Spirit Combo Insulin Pump and Accu-Chek Spirit Pump, Roche Diagnostics GmbH (HSA 600:41/01-016/15/07_20) | |
24 Apr 2015 | IMMULITE 2000 and IMMULITE 2000 Xpi, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/15/20_18) | |
24 Apr 2015 | Siemens BCS and BCS XP System, Siemens Healthcare Diagnostics Products GmbH (HSA 600:41/01-022/15/21_19) | |
23 Apr 2015 | Medtronic Synchromed II Programmable Pump (20ml and 40ml), Medtronic Inc (HSA 600:41/01-009/15/05_01) | |
23 Apr 2015 | OPTI blood gas analyser, OPTI Medical Systems Inc (HSA 600:41/01-033/15/02_17) | |
23 Apr 2015 | Chroma Coronary Bare Metal Stent System, Biosensors Europe SA (HSA 600:41/01-223/15/02_16) | |
22 Apr 2015 | ORTHO VISION™ Analyzer for ORTHO BioVue® Cassettes, Ortho-Clinical Diagnostics, Inc (HSA 600:41/01-002/15/15_19) | |
22 Apr 2015 | Revaclear 400 dialyser, Gambro Dialysatoren GmbH (HSA 600:41/01-011/15/03_08) | |
22 Apr 2015 | Hitachi X-ray Radiography/Fluoroscopy System, POPULUS Ti, Hitachi Medical Corporation (HSA 600:41/01-054/15/02_18) | |
22 Apr 2015 | Elekta Synergy, Synergy S, Infinity, Axxesse and Versa HD, Elekta Limited (HSA 600:41/01-101/15/04_20) | |
21 Apr 2015 | Toshiba Whole-body X-ray CT scanner with optional CT fluoroscopy, Toshiba Medical System Corporation (HSA 600:41/01-064/15/01_16) | |
21 Apr 2015 | Battery packs for deltastream MDC console and iLA activve console, Medos Medizintechnik AG (HSA 600:41/01-112/15/01_17) | |
21 Apr 2015 | Biolox Delta Ceramic Head, Biomet UK Ltd (HSA 600:41/01-183/15/02_09) | |
20 Apr 2015 | Connecting Screw for Insertion of DHS Blade, Synthes GmbH (HSA 600:41/01-002/15/14_19) | |
20 Apr 2015 | Ki67-MM1 Bond Ready To Use and Ki67-MM1 Concentrate, Leica Biosystems Newcastle Ltd (HSA 600:41/01-126/15/01_20) | |
17 Apr 2015 | Cobas b 123 < 4 > POC system, Roche Diagnostics GmbH (HSA 600:41/01-016/15/06_18) | |
17 Apr 2015 | Morce Power Plus Electronic Morcellator, Richard Wolf GmbH (HSA 600:41/01-119/15/01_08) | |
17 Apr 2015 | VITEK 2, VITEK 2 Compact, VITEK MS - MYLA V 3.X servers, Biomerieux SA (HSA 600:41/01-146/15/02_17) | |
16 Apr 2015 | Medtronic Neuromodulation Deep Brain Stimulation System extensions, Medtronic, Inc (HSA 600:41/01-009/15/04_19) | |
16 Apr 2015 | Dimension Integrated Chemistry Systems, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/15/19_08) | |
15 Apr 2015 | Olympus® EVIS Exera III Endoscopy System, Olympus Medical Systems Corp (HSA 600:41/01-004/15/02_09) | |
15 Apr 2015 | Centricity PACS-IW and Centricity PACS-IW with Universal Viewer, GE Healthcare (HSA 600:41/01-010/15/08_16) | |
15 Apr 2015 | Alaris® System PC Unit, CareFusion (HSA 600:41/01-087/15/02_18) | |
15 Apr 2015 | BTE Primus RS, BTE Technologies Inc (HSA 600:41/01-273/15/01_20) | |
14 Apr 2015 | Synthes Angular Stable Locking System, Synthes GmbH (HSA 600:41/01-002/15/11_01) | |
14 Apr 2015 | VITROS 5,1 FS Chemistry System, VITROS 4600 Chemistry System and VITROS 5600 Integrated System, Ortho-Clinical Diagnostics, Inc (HSA 600:41/01-002/15/12_19) | |
14 Apr 2015 | Oscillating Saw Attachment, Synthes GmbH (HSA 600:41/01-002/15/13_17) | |
14 Apr 2015 | Compact Airway Modules E/M-CAiOVX, GE Finland Oy (HSA 600:41/01-010/15/07_18) | |
13 Apr 2015 | Baxter Sodium Chloride Irrigation USP 0.9%, Baxter Healthcare Pty Ltd (HSA 600:41/01-001/15/02_02) | |
13 Apr 2015 | Fresenius Medical Care haemodialysis bloodline for 4008 dialysis machine, Fresenius Medical Care (Jiangsu) Pte Ltd (HSA 600:41/01-062/15/02_16) | |
10 Apr 2015 | Persona Anterior Referencing Locking Boom Femoral Sizer, Zimmer Inc (HSA 600:41/01-008/15/03_08) | |
10 Apr 2015 | da Vinci surgical system drapes, Intuitive Surgical Inc (HSA 600:41/01-070/15/06_17) | |
10 Apr 2015 | Autostainer instruments using HercepTest, Dako Denmark A/S (HSA 600:41/01-086/15/01_09) | |
10 Apr 2015 | Natus neoBLUE Blanket LED Phototherapy System - fiberoptic pads, Natus Medical Incorporated (HSA 600:41/01-113/15/01_11) | |
10 Apr 2015 | AQT90 FLEX Analyzer, Radiometer Medical Aps (HSA 600:41/01-219/15/03_01) | |
09 Apr 2015 | Bard Max-Core Disposable Core Biopsy System, Bard Peripheral Vascular Inc (HSA 600:41/01-050/15/02_16) | |
09 Apr 2015 | Titan™ Stabilizer and Titan™ 360 Stabilizer: Suction Tubing Clip, Terumo Cardiovascular Systems Corporation (HSA 600:41/01-272/15/01_09) | |
07 Apr 2015 | Maquet FLOW-i Anesthesia System, Maquet Critical Care AB (HSA 600:41/01-017/15/06_08) | |
02 Apr 2015 | Nellix EndoVascular Aneurysm Sealing System, Endologix Inc (HSA 600:41/01-057/15/02_02) | |
02 Apr 2015 | Allset Gold DRB 1-13 High Res, DRB 1-13 SSP Unitray 12 Tests and DRB 1-13 SSP Unitray W/TAQ 12 Tests, Life Technologies Corporation (HSA 600:41/01-220/15/01_11) |