Field Safety Notices
Field Safety Notice - Mar 2015
31 March 2015
Audiences
Healthcare professional
Industry member
Product-type
Medical devices
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Table caption
Date of Notification | Title | FSN |
|---|---|---|
31 Mar 2015 | CIDEX OPA Solution Test Strips, Advanced Sterilization Products (HSA 600:41/01-002/15/10_01) | HSA 6004101-002-15-10_01 FSN [PDF, 32 KB] (opens in new tab) |
31 Mar 2015 | Nellix EndoVascular Aneurysm Sealing System, Endologix Inc (HSA 600:41/01-148/15/01_02) | HSA 6004101-148-15-01_02 FSN [PDF, 81 KB] (opens in new tab) |
30 Mar 2015 | Oxoid Antimicrobial Testing Disc - CN10 Gentamicin, Oxoid Limited (HSA 600:41/01-178/15/01_07) | HSA 6004101-178-15-01_07 FSN [PDF, 77 KB] (opens in new tab) |
27 Mar 2015 | ADVIA Centaur XPT System, Siemens Healthcare Diagnostics (HSA 600:41/01-022/15/18_16) | HSA 6004101-022-15-18-16 FSN [PDF, 217 KB] (opens in new tab) |
27 Mar 2015 | Bard Conquest PTA Balloon Dilatation Catheter, Bard Peripheral Vascular Inc (HSA 600:41/01-050/15/01_09) | HSA 6004101-050-15-01_09 FSN [PDF, 1988 KB] (opens in new tab) |
27 Mar 2015 | da Vinci® Xi™ Surgical System Patient Cart Arms, Intuitive Surgical Inc (HSA 600:41/01-070/15/05_11) | HSA 6004101-070-15-05_11 FSN [PDF, 94 KB] (opens in new tab) |
27 Mar 2015 | TeraRecon Aquarius Workstation, TeraRecon, Inc (HSA 600:41/01-271/15/01_11) | HSA 6004101-271-15-01_11 FSN [PDF, 188 KB] (opens in new tab) |
26 Mar 2015 | Edwards Fem-Flex II Femoral Arterial Cannula and Edwards Fem-Flex II Femoral Venous Cannula, Edwards Lifesciences LLC (HSA 600:41/01-060/15/01_02) | HSA 6004101-060-15-01_02 FSN [PDF, 5370 KB] (opens in new tab) |
25 Mar 2015 | Persona Trabecular Metal™ Tibial Plate, all sizes, Zimmer Inc (HSA 600:41/01-008/15/02_11) | HSA 6004101-008-15-02_11 FSN [PDF, 322 KB] (opens in new tab) |
25 Mar 2015 | RaySearch Laboratories RayStation, RaySearch Laboratories AB (HSA 600:41/01-070/15/04_11) | HSA 6004101-070-15-04_11 FSN [PDF, 610 KB] (opens in new tab) |
24 Mar 2015 | ADVIA Chemistry Lipase, Siemens Healthcare Diagnostics (HSA 600:41/01-022/15/17_07) | HSA 6004101-022-15-17_07 FSN [PDF, 353 KB] (opens in new tab) |
23 Mar 2015 | Trauma DHS/DCS Impactor Tip, Synthes GmbH (HSA 600:41/01-002/15/09_09) | HSA 6004101-002-15-09_09 FSN [PDF, 110 KB] (opens in new tab) |
23 Mar 2015 | Homocysteine Enzymatic Assay, Roche Diagnostics GmbH (HSA 600:41/01-016/15/05_01) | HSA 6004101-016-15-05_01 FSN [PDF, 819 KB] (opens in new tab) |
20 Mar 2015 | ADVIA Centaur XPT System, Siemens Healthcare Diagnostics, Inc (HSA 600:41/01-022/15/16_16) | HSA 6004101-022-15-16-16 FSN [PDF, 283 KB] (opens in new tab) |
20 Mar 2015 | Trellis™ 6 and Trellis™ 8 Peripheral Infusion Systems, Medtronic, PLC (HSA 600:41/01-046/15/03_11) | HSA 6004101-046-15-03_11 FSN [PDF, 473 KB] (opens in new tab) |
20 Mar 2015 | EOS™ X-Ray Imaging Acquisition System, EOS Imaging (HSA 600:41/01-238/15/01_08) | HSA 6004101-238-15-01_08 FSN [PDF, 75 KB] (opens in new tab) |
19 Mar 2015 | Artis Q and Artis Q.zen family systems, Siemens AG (HSA 600:41/01-022/15/15_17) | HSA 6004101-022-15-15_17 FSN [PDF, 71 KB] (opens in new tab) |
18 Mar 2015 | ORTHO VISION™ Analyser for ORTHO BioVue® Cassettes, Ortho-Clinical Diagnostics, Inc (HSA 600:41/01-002/15/08_11) | HSA 6004101-002-15-08_11 FSN [PDF, 147 KB] (opens in new tab) |
18 Mar 2015 | Model 5392 Dual-Chamber External Pulse Generator, Medtronic, Inc (HSA 600:41/01-009/15/03_16) | HSA 6004101-009-15-03-16 FSN [PDF, 233 KB] (opens in new tab) |
18 Mar 2015 | FX CorDiax High-Flux Dialysers and FX CorDiax Haemodiafilters, Fresenius Medical Care AG & Co KGaA (HSA 600:41/01-062/15/01_11) | HSA 6004101-062-15-01_11 FSN [PDF, 1234 KB] (opens in new tab) |
17 Mar 2015 | PFNA and PFNA-II Femoral Nails and PFNA-II Endcaps, Synthes GmbH (HSA 600:41/01-002/15/07_01) | HSA 6004101-002-15-07_01 FSN [PDF, 46 KB] (opens in new tab) |
17 Mar 2015 | MEDUMAT Transport, WEINMANN Emergency Medical Technology GmbH (HSA 600:41/01-039/15/01_02) | HSA 6004101-039-15-01_02 FSN [PDF, 79 KB] (opens in new tab) |
17 Mar 2015 | Biolox Delta Ceramic Head 36mm -4mm Neck, Biomet UK Ltd (HSA 600:41/01-183/15/01_11) | HSA 6004101-183-15-01_11 FSN [PDF, 2931 KB] (opens in new tab) |
16 Mar 2015 | Cross-Link Clamp for Rods Ø 6.0 mm, preassembled, Titanium Alloy (TAN), dark blue, Synthes GmbH (HSA 600:41/01-002/15/06_17) | HSA 6004101-002-15-06_17 FSN [PDF, 25 KB] (opens in new tab) |
16 Mar 2015 | ADVIA Centaur XPT System, Siemens Healthcare Diagnostics, Inc (HSA 600:41/01-022/15/14_16) | HSA 6004101-022-15-14-16 FSN [PDF, 634 KB] (opens in new tab) |
13 Mar 2015 | VITROS® 5,1 FS Chemistry System, Ortho-Clinical Diagnostics, Inc (HSA 600:41/01-002/15/05_09) | HSA 6004101-022-15-05_09 FSN [PDF, 218 KB] (opens in new tab) |
13 Mar 2015 | Hamilton-G5 and Hamilton-S1 ventilators, Hamilton Medical AG (HSA 600:41/01-248/15/01_02) | HSA 6004101-248-15-01_02 FSN [PDF, 2243 KB] (opens in new tab) |
13 Mar 2015 | Aurinio L50 Examination Light, Trilux Medical GmbH & Co KG (HSA 600:41/01-270/15/01_01) | HSA 6004101-270-15-01_01 FSN [PDF, 832 KB] (opens in new tab) |
12 Mar 2015 | Pedicle Awl 4.0mm w/Canevasit Handle and Pedicle Awl 4.0mm w/Silicone Handle, Synthes GmbH (HSA 600:41/01-002/15/04_09) | HSA 6004101-002-15-04_09 FSN [PDF, 33 KB] (opens in new tab) |
12 Mar 2015 | Maquet FLOW-i Anesthesia System, Maquet Critical Care AB (HSA 600:41/01-017/15/05_08) | HSA 6004101-017-15-05_08 FSN [PDF, 101 KB] (opens in new tab) |
12 Mar 2015 | ExacTrac 6.x Patient Positioning System, BrainLab AG (HSA 600:41/01-047/15/01_02) | HSA 6004101-047-15-01_02 FSN [PDF, 150 KB] (opens in new tab) |
10 Mar 2015 | T2100 Treadmill, GE Medical Systems Information Techonologies (HSA 600:41/01-010/15/06_08) | HSA 6004101-010-15-06_08 FSN [PDF, 167 KB] (opens in new tab) |
09 Mar 2015 | CATALYS Precision Laser System, OptiMedica Corporation (HSA 600:41/01-018/15/01_01) | HSA 6004101-018-15-01_01 FSN [PDF, 294 KB] (opens in new tab) |
06 Mar 2015 | ACUSON S2000 Automated Breast Volume Scanner, Siemens Medical Solutions USA, Inc (HSA 600:41/01-022/15/13_11) | HSA 6004101-022-15-13-11 FSN [PDF, 1118 KB] (opens in new tab) |
05 Mar 2015 | IMMULITE 2000/IMMULITE 2000 XPi Water and Liquid Waste Bottles, Siemens Healthcare Diagnostics, Inc (HSA 600:41/01-022/15/12_09) | HSA 6004101-022-15-12_09 FSN [PDF, 321 KB] (opens in new tab) |
05 Mar 2015 | GemLock Long Hex Driver, Zimmer Dental (HSA 600:41/01-214/15/01_11) | HSA 6004101-214-15-01_11 FSN [PDF, 140 KB] (opens in new tab) |
05 Mar 2015 | BioPath 035 Paclitaxel releasing over the wire (OTW) PTA balloon catheter, Biosensors Europe SA (HSA 600:41/01-223/15/01_11) | HSA 6004101-223-15-01_11 FSN [PDF, 222 KB] (opens in new tab) |
04 Mar 2015 | Sony LMD-1951MD Monitor used with SpyGlass, Boston Scientific Corporation (HSA 600:41/01-007/15/01_07) | HSA 6004101-007-15-01_07 FSN [PDF, 3597 KB] (opens in new tab) |
04 Mar 2015 | MAQUET CARDIOHELP System, Maquet Cardiopulmonary AG (HSA 600:41/01-017/15/04_02) | HSA 6004101-017-15-04_02 FSN [PDF, 799 KB] (opens in new tab) |
03 Mar 2015 | CODMAN® CERTAS™ Therapy Management System, Medos International SARL (HSA 600:41/01-002/15/03_11) | HSA 6004101-002-15-03_11 FSN [PDF, 155 KB] (opens in new tab) |
03 Mar 2015 | StealthStation AxiEM and Fusion EM, Medtronic Navigation, Inc (HSA 600:41/01-009/15/02_08) | HSA 6004101-009-15-02_08 FSN [PDF, 59 KB] (opens in new tab) |
03 Mar 2015 | Artis One System, Siemens Shenzhen Magnetic Resonance Ltd (HSA 600:41/01-022/15/11_11) | HSA 6004101-022-15-11-11 FSN [PDF, 75 KB] (opens in new tab) |
03 Mar 2015 | da Vinci Si EndoWrist® One Vessel Sealer and da Vinci Xi EndoWrist® Vessel Sealer, Intuitive Surgical Inc (HSA 600:41/01-070/15/03_11) | HSA 6004101-070-15-03_11 FSN [PDF, 322 KB] (opens in new tab) |
02 Mar 2015 | Titanium Elastic Nail (TEN) Inserter, Synthes GmbH (HSA 600:41/01-002/15/02_09) | HSA 6004101-002-15-02_09 FSN [PDF, 57 KB] (opens in new tab) |