Field Safety Notices
Field Safety Notice - May 2015
Audiences
Healthcare professional
Industry member
Product type
Medical devices
31 May 2015
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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) | |
29 May 2015 | HeartWare® Ventricular Assist System (HVAD), HeartWare Inc (HSA 600:41/01-207/15/02_18) | |
28 May 2015 | AllSet+ Gold and UniTray, Life Technologies Corporation (HSA 600:41/01-220/15/02_19) | |
28 May 2015 | S3 and S2 Fluid Packs, Roche Diagnostics GmbH (HSA 600:41/01-016/15/10_20) | |
27 May 2015 | LifeCycle for Prenatal Screening, Wallac Oy (HSA 600:41/01-127/15/02_17) | |
26 May 2015 | EVIS EXERA II Duodenovideoscope, Olympus Medical Systems Corporation (HSA 600:41/01-004/15/04_16) | |
25 May 2015 | Tibial Alignment Guide – iAssist Knee System, Zimmer CAS (HSA 600:41/01-008/15/07_19) | |
25 May 2015 | Omrix Pressure Regulator, Omrix Biopharmaceuticals Ltd (HSA 600:41/01-002/15/22_20) | |
22 May 2015 | Siemens Artis Zee Family System, Siemens AG (HSA 600:41/01-022/15/27_18) | |
22 May 2015 | ADVIA Centaur Tnl-Ultra, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/15/26_17) | |
21 May 2015 | Tubeset Declog Diego Elite and Tubeset Standard Diego Elite, Gyrus ACMI Inc (HSA 600:41/01-004/15/03_09) | |
21 May 2015 | Hamilton Medical lnfant Flow Sensor, single use, Hamilton Medical AG (HSA 600:41/01-248/15/02_16) | |
21 May 2015 | Wand STA Handpiece, Milestone Scientific Inc (HSA 600:41/01-276/15/01_01) | |
21 May 2015 | Oncentra Brachy, Nucletron BV (HSA 600:41/01-101/15/05_24) | |
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) | |
21 May 2015 | Invivo Expression MRI Patient Monitoring System, Invivo Corporation (HSA 600:41/01-026/15/17_08) | |
19 May 2015 | ORTHO VISION™ Analyzer, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-002/15/20_21) | |
19 May 2015 | CELLSEARCH® Circulating Tumor Cell Kits, Janssen Diagnostics llc (HSA 600:41/01-002/15/21_23) | |
19 May 2015 | Pulsar-18 and Pulsar-35 Self Expanding Peripheral Stent System, Biotronik AG (HSA 600:41/01-269/15/02_22) | |
19 May 2015 | Boston Scientific Reliance 4-Front single coil defibrillation leads, Boston Scientific Corporation (HSA 600:41/01-007/15/03_08) | |
18 May 2015 | Philips IntelliVue Information Center iX, Philips Medical Systems (HSA 600:41/01-026/15/16_09) | |
15 May 2015 | Philips Dura Diagnost X-ray system, Philips Healthcare (Suzhou) Co Ltd (HSA 600:41/01-026/15/14_01) | |
15 May 2015 | Philips Digital Diagnost Radiography System, Philips Medical Systems, DMC GmbH (HSA 600:41/01-026/15/13_18) | |
15 May 2015 | Philips AFFINITI 50 Ultrasound System, Philips Ultrasound Inc (HSA 600:41/01-026/15/15_08) | |
15 May 2015 | Philips AFFINITI 70 Ultrasound System, Philips Ultrasound Inc (HSA 600:41/01-026/15/15_08) | |
15 May 2015 | Biometrix Thorametrix Thoracic Drainage System, Biometrix Ltd (HSA 600:41/01-051/15/02_08) | |
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) | |
14 May 2015 | EVOTECH® Endoscope Cleaner and Reprocessor (ECR), Advanced Sterilization Products (HSA 600:41/01-002/15/19_17) | |
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) | |
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) | |
13 May 2015 | Abbott Clinical Chemistry Alkaline Wash, Abbott Laboratories (HSA 600:41/01-005/15/03_18) | |
13 May 2015 | VITROS Chemistry Products Performance Verifier I, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-002/15/18_20) | |
12 May 2015 | Karl Storz Laparoscopic Power Morcellators, Karl Storz GmbH & Co KG (HSA 600:41/01-133/15/01_19) | |
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) | |
11 May 2015 | Ysio Max, Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Siemens AG (HSA 600:41/01-022/15/25_09) | |
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) | |
8 May 2015 | Philips EPIQ 5 Ultrasound System, Philips Ultrasound Inc (HSA 600:41/01-026/15/12_20) | |
8 May 2015 | Philips EPIQ 7 Ultrasound System, Philips Ultrasound Inc (HSA 600:41/01-026/15/12_20) | |
7 May 2015 | Cios Alpha mobile C-arm X-ray System, Siemens AG (HSA 600:41/01-022/15/24_18) | |
7 May 2015 | Camlog Screw-Line Implant, Altatec GmbH (HSA 600:41/01-274/15/01_08) | |
7 May 2015 | RAPIDLab 1260/ 1265 Blood Gas Analyzers, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/15/23_24) | |
7 May 2015 | M/DN 4.5mm Cortical Screws, Zimmer Inc (HSA 600:41/01-008/15/06_17) | |
6 May 2015 | ORTHO VISION™ Analyzer for ORTHO BioVue® Cassettes, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-002/15/17_25) | |
6 May 2015 | Sekisui Diagnostics MULTIGENT Acetaminophen Assay, Sekisui Diagnostics (HSA 600:41/01-005/15/02_16) | |
6 May 2015 | Beta-2-Microglobulin PET Kit, Dako Denmark A/S (HSA 600:41/01-086/15/02_01) | |
5 May 2015 | ULTRA FAST-FIX Knot Pusher Suture Cutters, Smith & Nephew Inc (HSA 600:41/01-073/15/04_23) | |
4 May 2015 | PRI Femoral Impactor Head, Zimmer Inc (HSA 600:41/01-008/15/05_21) | |
4 May 2015 | COULTER DxH Diluent, Beckman Coulter Inc (HSA 600:41/01-052/15/02_22) |