Field Safety Notices
Field Safety Notice - May 2015
31 May 2015
Audiences
Healthcare professional
Industry member
Product-type
Medical devices
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Table caption
Date of Notification | Title | FSN |
|---|---|---|
29 May 2015 | Astraia Software, Astraia Software GmbH (HSA 600:41/01-170/15/01_17) | HSA 6004101-170-15-01_17 FSN [PDF, 44 KB] (opens in new tab) |
29 May 2015 | HeartWare® Ventricular Assist System (HVAD), HeartWare Inc (HSA 600:41/01-207/15/02_18) | HSA 6004101-207-15-02_18 FSN [PDF, 182 KB] (opens in new tab) |
28 May 2015 | AllSet+ Gold and UniTray, Life Technologies Corporation (HSA 600:41/01-220/15/02_19) | HSA 6004101-220-15-02_19 FSN [PDF, 277 KB] (opens in new tab) |
28 May 2015 | S3 and S2 Fluid Packs, Roche Diagnostics GmbH (HSA 600:41/01-016/15/10_20) | HSA 6004101-016-15-10_20 FSN [PDF, 1214 KB] (opens in new tab) |
27 May 2015 | LifeCycle for Prenatal Screening, Wallac Oy (HSA 600:41/01-127/15/02_17) | HSA 6004101-127-15-02_17 FSN [PDF, 3600 KB] (opens in new tab) |
26 May 2015 | EVIS EXERA II Duodenovideoscope, Olympus Medical Systems Corporation (HSA 600:41/01-004/15/04_16) | HSA 6004101-004-15-04_16 FSN [PDF, 34 KB] (opens in new tab) |
25 May 2015 | Tibial Alignment Guide – iAssist Knee System, Zimmer CAS (HSA 600:41/01-008/15/07_19) | HSA 6004101-008-15-07_19 FSN [PDF, 366 KB] (opens in new tab) |
25 May 2015 | Omrix Pressure Regulator, Omrix Biopharmaceuticals Ltd (HSA 600:41/01-002/15/22_20) | HSA 6004101-002-15-22_20 FSN [PDF, 40 KB] (opens in new tab) |
22 May 2015 | Siemens Artis Zee Family System, Siemens AG (HSA 600:41/01-022/15/27_18) | HSA 6004101-022-15-27_18 FSN [PDF, 69 KB] (opens in new tab) |
22 May 2015 | ADVIA Centaur Tnl-Ultra, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/15/26_17) | HSA 6004101-022-15-26_17 FSN [PDF, 148 KB] (opens in new tab) |
21 May 2015 | Tubeset Declog Diego Elite and Tubeset Standard Diego Elite, Gyrus ACMI Inc (HSA 600:41/01-004/15/03_09) | HSA 6004101-004-15-03_09 FSN [PDF, 113 KB] (opens in new tab) |
21 May 2015 | Hamilton Medical lnfant Flow Sensor, single use, Hamilton Medical AG (HSA 600:41/01-248/15/02_16) | HSA 6004101-248-15-02-16 FSN [PDF, 2746 KB] (opens in new tab) |
21 May 2015 | Wand STA Handpiece, Milestone Scientific Inc (HSA 600:41/01-276/15/01_01) | HSA 6004101-276-15-01_01 FSN [PDF, 353 KB] (opens in new tab) |
21 May 2015 | Oncentra Brachy, Nucletron BV (HSA 600:41/01-101/15/05_24) | HSA 6004101-101-15-05_24 FSN [PDF, 107 KB] (opens in new tab) |
21 May 2015 | Nellcor OxiMax N-65 Handheld Pulse Oximeter and Nellcor OxiMax N-560 Pulse Oximeter, Covidien llc (HSA 600:41/01-046/15/06_25) | HSA 6004101-046-15-06_25 FSN [PDF, 476 KB] (opens in new tab) |
21 May 2015 | Invivo Expression MRI Patient Monitoring System, Invivo Corporation (HSA 600:41/01-026/15/17_08) | HSA 6004101-026-15-17_08 FSN [PDF, 86 KB] (opens in new tab) |
19 May 2015 | ORTHO VISION™ Analyzer, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-002/15/20_21) | HSA 6004101-002-15-20_21 FSN [PDF, 67 KB] (opens in new tab) |
19 May 2015 | CELLSEARCH® Circulating Tumor Cell Kits, Janssen Diagnostics llc (HSA 600:41/01-002/15/21_23) | HSA 6004101-002-15-21_23 FSN [PDF, 159 KB] (opens in new tab) |
19 May 2015 | Pulsar-18 and Pulsar-35 Self Expanding Peripheral Stent System, Biotronik AG (HSA 600:41/01-269/15/02_22) | HSA 6004101-269-15-02_22 FSN [PDF, 120 KB] (opens in new tab) |
19 May 2015 | Boston Scientific Reliance 4-Front single coil defibrillation leads, Boston Scientific Corporation (HSA 600:41/01-007/15/03_08) | HSA 6004101-007-15-03_08 FSN [PDF, 507 KB] (opens in new tab) |
18 May 2015 | Philips IntelliVue Information Center iX, Philips Medical Systems (HSA 600:41/01-026/15/16_09) | HSA 6004101-026-15-16_09 FSN [PDF, 187 KB] (opens in new tab) |
15 May 2015 | Philips Dura Diagnost X-ray system, Philips Healthcare (Suzhou) Co Ltd (HSA 600:41/01-026/15/14_01) | HSA 6004101-026-15-14_01 FSN [PDF, 119 KB] (opens in new tab) |
15 May 2015 | Philips Digital Diagnost Radiography System, Philips Medical Systems, DMC GmbH (HSA 600:41/01-026/15/13_18) | HSA 6004101-026-15-13_18 FSN [PDF, 1893 KB] (opens in new tab) |
15 May 2015 | Philips AFFINITI 50 Ultrasound System, Philips Ultrasound Inc (HSA 600:41/01-026/15/15_08) | HSA 6004101-026-15-15_08 FSN1 [PDF, 158 KB] (opens in new tab) |
15 May 2015 | Philips AFFINITI 70 Ultrasound System, Philips Ultrasound Inc (HSA 600:41/01-026/15/15_08) | HSA 6004101-026-15-15_08 FSN2 [PDF, 156 KB] (opens in new tab) |
15 May 2015 | Biometrix Thorametrix Thoracic Drainage System, Biometrix Ltd (HSA 600:41/01-051/15/02_08) | HSA 6004101-051-15-02_08 FSN [PDF, 451 KB] (opens in new tab) |
14 May 2015 | Eon™ Wall Charger Model 3701 and Eon™ Portable Charger Model 3711, St. Jude Medical (HSA 600:41/01-025/15/02_09) | HSA 6004101-025-15-02_09 FSN [PDF, 330 KB] (opens in new tab) |
14 May 2015 | EVOTECH® Endoscope Cleaner and Reprocessor (ECR), Advanced Sterilization Products (HSA 600:41/01-002/15/19_17) | HSA 6004101-002-15-19_17 FSN [PDF, 1537 KB] (opens in new tab) |
14 May 2015 | GE Corometrics Models 171, 172, 173 and 174 series monitors, GE Medical Systems Information Technologies Inc (HSA 600:41/01-010/15/09_11) | HSA 6004101-010-15-09-11 FSN [PDF, 171 KB] (opens in new tab) |
14 May 2015 | AirCurve 10 CS PaceWave, S9 VPAP Adapt/Adapt PaceWave, S9 VPAP Tx, S9 AutoSet CS/CS-A/CS Easv, AutoSet CS/CS-2/CS-A, VPAP Adapt/Adapt SV, VPAP Tx, Lumis Tx, ResMed Ltd (HSA 600:41/01-275/15/01_16) | HSA 6004101-275-15-01_16 FSN [PDF, 81 KB] (opens in new tab) |
13 May 2015 | Abbott Clinical Chemistry Alkaline Wash, Abbott Laboratories (HSA 600:41/01-005/15/03_18) | HSA 6004101-005-15-03_18 FSN [PDF, 21 KB] (opens in new tab) |
13 May 2015 | VITROS Chemistry Products Performance Verifier I, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-002/15/18_20) | HSA 6004101-002-15-18_20 FSN [PDF, 158 KB] (opens in new tab) |
12 May 2015 | Karl Storz Laparoscopic Power Morcellators, Karl Storz GmbH & Co KG (HSA 600:41/01-133/15/01_19) | HSA 6004101-133-15-01_19 FSN [PDF, 2356 KB] (opens in new tab) |
12 May 2015 | Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless and Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff, Covidien llc (HSA 600:41/01-046/15/05_17) | HSA 6004101-046-15-05_17 FSN [PDF, 701 KB] (opens in new tab) |
11 May 2015 | Ysio Max, Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Siemens AG (HSA 600:41/01-022/15/25_09) | HSA 6004101-022-15-25_09 FSN [PDF, 79 KB] (opens in new tab) |
8 May 2015 | CREA plus, CREP2, LACT2, Lactate, GLU, TRIGL/TG, TRIGGB, TRIG/GB, CHOL/CHOL2, HDL-C plus 3rd generation/HDLC3, LDL_C plus 2nd generation/LDL_C, UA2/UA plus, Roche Diagnostics GmbH (HSA 600:41/01-016/15/09_16) | HSA 6004101-016-15-09_16 FSN [PDF, 1297 KB] (opens in new tab) |
8 May 2015 | Philips EPIQ 5 Ultrasound System, Philips Ultrasound Inc (HSA 600:41/01-026/15/12_20) | HSA 6004101-026-15-12_20 FSN1 [PDF, 323 KB] (opens in new tab) |
8 May 2015 | Philips EPIQ 7 Ultrasound System, Philips Ultrasound Inc (HSA 600:41/01-026/15/12_20) | HSA 6004101-026-15-12_20 FSN2 [PDF, 290 KB] (opens in new tab) |
7 May 2015 | Cios Alpha mobile C-arm X-ray System, Siemens AG (HSA 600:41/01-022/15/24_18) | HSA 6004101-022-15-24_18 FSN [PDF, 153 KB] (opens in new tab) |
7 May 2015 | Camlog Screw-Line Implant, Altatec GmbH (HSA 600:41/01-274/15/01_08) | HSA 6004101-274-15-01_08 FSN [PDF, 2681 KB] (opens in new tab) |
7 May 2015 | RAPIDLab 1260/ 1265 Blood Gas Analyzers, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/15/23_24) | HSA 6004101-022-15-23_24 FSN [PDF, 184 KB] (opens in new tab) |
7 May 2015 | M/DN 4.5mm Cortical Screws, Zimmer Inc (HSA 600:41/01-008/15/06_17) | HSA 6004101-008-15-06_17 FSN [PDF, 140 KB] (opens in new tab) |
6 May 2015 | ORTHO VISION™ Analyzer for ORTHO BioVue® Cassettes, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-002/15/17_25) | HSA 6004101-002-15-17_25 FSN [PDF, 61 KB] (opens in new tab) |
6 May 2015 | Sekisui Diagnostics MULTIGENT Acetaminophen Assay, Sekisui Diagnostics (HSA 600:41/01-005/15/02_16) | HSA 6004101-005-15-02-16 FSN [PDF, 154 KB] (opens in new tab) |
6 May 2015 | Beta-2-Microglobulin PET Kit, Dako Denmark A/S (HSA 600:41/01-086/15/02_01) | HSA 6004101-086-15-02_01 FSN [PDF, 71 KB] (opens in new tab) |
5 May 2015 | ULTRA FAST-FIX Knot Pusher Suture Cutters, Smith & Nephew Inc (HSA 600:41/01-073/15/04_23) | HSA 6004101-073-15-04_23 FSN [PDF, 132 KB] (opens in new tab) |
4 May 2015 | PRI Femoral Impactor Head, Zimmer Inc (HSA 600:41/01-008/15/05_21) | HSA 6004101-008-15-05_21 FSN [PDF, 54 KB] (opens in new tab) |
4 May 2015 | COULTER DxH Diluent, Beckman Coulter Inc (HSA 600:41/01-052/15/02_22) | HSA 6004101-052-15-02_22 FSN [PDF, 83 KB] (opens in new tab) |