Field Safety Notices
Field Safety Notice - Jan 2016
Audiences
Healthcare professional
Industry member
Product type
Medical devices
31 January 2016
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Table caption
Date of Notification | Title | FSN |
|---|---|---|
29 Jan 2016 | Accu-Chek Inform II Base Unit, Handheld Base Unit, Roche HBU/BU Control Panel, Accu-Chek Inform II meter+RF, Accu-Chek Inform II meter, CoaguChek XS Pro Int'l, CoaguChek XS Plus Int'l, Roche Diagnostics GmbH (HSA 600:41/01-016/16/02_31) | |
27 Jan 2016 | Ellipse Nordlys/Sirius, Ellipse A/S (HSA 600:41/01-288/16/01_33) | |
27 Jan 2016 | LEGION Screw-On Hemi Stepped Tibial Wedge, 5mm Sz 5-6 Lt-Lat/Rt-Mdl, Smith & Nephew Inc (HSA 600:41/01-073/16/03_19) | |
27 Jan 2016 | Haemonetics MCS+ System, Haemonetics Automated Cell Processor ACP 215, Haemonetics Corporation (HSA 600:41/01-070/16/02_29) | |
27 Jan 2016 | Eclipse™ Treatment Planning System, Varian Medical Systems Inc (HSA 600:41/01-058/16/01_25) | |
26 Jan 2016 | iChemVELOCITY Urine Chemistry Strips, Iris Diagnostics (HSA 600:41/01-052/16/02_22) | |
26 Jan 2016 | Trilogy 100, Trilogy 200, and Trilogy 202 units with software versions 13.2.04 or 13.2.05 or 14.0.00 or 14.1.01, Respironics Inc (HSA 600:41/01-026/16/04_18) | |
26 Jan 2016 | ARCHITECT STAT High Sensitive Troponin-I Reagent Kit, Abbott Ireland (Diagnostics Division) (HSA 600:41/01-005/16/01_24) | |
26 Jan 2016 | VITROS® 4600 Chemistry System, VITROS® 5600 Chemistry System, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-002/16/02_23) | |
25 Jan 2016 | Leica M525 OH4 / M720 OH5 Surgical Microscopes with 400W Illumination, Leica Microsystems (Schweiz) AG (HSA 600:41/01-126/16/01_56) | |
25 Jan 2016 | BrightView, BrightView X, BrightView XCT, BrightView XCT Upgrade, Philips Medical Systems (Cleveland) Inc (HSA 600:41/01-026/16/02_48) | |
25 Jan 2016 | cobas® b 123 POC System, Roche Diagnostics GmbH (HSA 600:41/01-016/16/01_20) | |
22 Jan 2016 | LCP Distal Tibial Plate & Expert™ A2FN, Synthes GmbH (HSA 600:41/01-002/16/01_55) | |
22 Jan 2016 | HP cosmos Medical treadmill ergometer, h/p/cosmos Sports & Medical GmbH (HSA 600:41/01-039/16/02_54) | |
21 Jan 2016 | Single Lumen Central Venous, Femoral Artery Pressure Monitoring & Radial Artery Pressure Monitoring Catheter Sets, Cook Incorporated (HSA 600:41/01-013/16/01_44) | |
20 Jan 2016 | HF440 devices with fifth pump option, Infomed SA (HSA 600:41/01-070/16/01_52) | |
19 Jan 2016 | Puritan Bennett™ 980 Ventilator System, Covidien llc (HSA 600:41/01-046/16/01_41) | |
19 Jan 2016 | DYONICS RF Broadnose 90 Wand, Smith & Nephew Inc (HSA 600:41/01-073/16/02_50) | |
19 Jan 2016 | ED-530XT Duodenoscope for Treatment, Fujifilm Corporation (HSA 600:41/01-173/16/01_40) | |
18 Jan 2016 | BCS/ BCS XP with Dade Innovin, Siemens Healthcare Diagnostics Products GmbH (HSA 600:41/01-022/16/03_61) | |
15 Jan 2016 | BEAVER 4.0mm Banana Blade, Smith & Nephew Inc (HSA 600:41/01-073/16/01_36) | |
14 Jan 2016 | ADVIA CENTAUR ENHANCED ESTRADIOL, IMMULITE 1000/IMMULITE 2000 ESTRADIOL [CC 16-03], Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/16/02_60) | |
14 Jan 2016 | Multipolar Bipolar Cup, CPT Femoral Stem, Versys Beaded Fullcoat Femoral Stem, Metasul Head, CoCr Head, NexGen Femoral Component, Natural-Knee Flex Femoral Component, Zimmer Unicompartmental Knee Femoral Component and 4 more devices, Zimmer Inc. (HSA 600:41/01-032/16/01_59) | |
13 Jan 2016 | INNOVANCE PFA P2Y, Siemens Healthcare Diagnostics Products GmbH (HSA 600:41/01-032/16/01_59) | |
12 Jan 2016 | T34 Ambulatory Syringe Pump, Caesarea Medical Electronics Ltd (HSA 600:41/01-287/16/01_33) | |
12 Jan 2016 | Philips IntelliVue Measurement Modules (X1, X2), Philips Medical Systems Boblinger GmbH (HSA 600:41/01-026/16/01_19) | |
12 Jan 2016 | PRN 50-M+ Digital Writer, GSI Group (HSA 600:41/01-010/16/01_29) | |
11 Jan 2016 | Phadia EliA SmDp Well, Phadia AB (HSA 600:41/01-033/16/01_57) | |
08 Jan 2016 | Guide Wire(s) and K-Wire(s) and Intramedullary Pin Metaizeau, Stryker Trauma GmbH (HSA 600:41/01-014/16/01_18) | |
07 Jan 2016 | Specify 5-6-5 Surgical Lead and Specify 2x8 Surgical Lead, Medtronic Inc. (HSA 600:41/01-009/16/01_17) | |
06 Jan 2016 | Sulcoflex Toric, Rayner Intraocular Lenses Ltd. (HSA 600:41/01-110/16/01_48) | |
05 Jan 2016 | 9131 Defibrillation Electrode, Cardiac Science Corporation (HSA 600:41/01-089/16/01_46) | |
05 Jan 2016 | ADVIA Centaur Systems PSA, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/16/01_58) | |
05 Jan 2016 | FRED easy AED, Schiller Medical (HSA 600:41/01-056/16/01_54) | |
04 Jan 2016 | COULTER® S-CAL® Calibrator Kits, Beckman Coulter Inc (HSA 600:41/01-052/16/01_38) | |
04 Jan 2016 | NexGen Precoat Tibial Plate & NexGen Option Tibial Plate, Zimmer Inc (HSA 600:41/01-008/16/01_45) | |
20 Nov 2015 | Evita Infinity V500, Babylog VN500 and Evita V300, Dragerwerk AG & Co. KGaA (HSA 600:41/01-063/15/03_37) |