Field Safety Notices
Field Safety Notice - Dec 2016
Audiences
Healthcare professional
Industry member
Product type
Medical devices
31 December 2016
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DATE OF NOTIFICATION | TITLE | FSN |
|---|---|---|
30 Dec 2016 | UniCel® DxH 800 Coulter® Cellular Analysis System, UniCel® DxH 600 Coulter® Cellular Analysis System, Beckman Coulter Inc (HSA 600:41/01-052/16/14_65) | |
30 Dec 2016 | Workstation power cable assembly on certain OEC MiniView 6800, OEC 9800, OEC 9900 systems, GE OCE Medical Systems, Inc (HSA 600:41/01-010/16/24_17) | |
29 Dec 2016 | Datascope Cardiosave Intra-Aortic Balloon Pump (IABP), Datascope Corp (HSA 600:41/01-017/16/08_56) | |
27 Dec 2016 | Glucose-6 Phosphate Dehydrogenase (G-6-PDH) Kit, Trinity Biotech (HSA 60041/01-212/16/01_59) | |
27 Dec 2016 | Ortho-Clinical VITROS Chemistry Products Na+ Slides, Ortho-Clinical Diagnostic Inc (HSA 600:41/01-303/16/08_60) | |
27 Dec 2016 | MEDPOR Facial and Oculoplastic Sizer Set, TLS and SPG Drain Systems, Stryker Leibinger GmbH & Co. KG (HSA 600:41/01-014/16/16_48) | |
23 Dec 2016 | Certofix Duo, Certofix Trio, Drucafix, B Braun Melsungen AG (HSA 600:41/01-012/16/12_63) | |
21 Dec 2016 | Philips DuraDiagnost & DuraDiagnost Compact X-ray system, Philips Healthcare (Suzhou) Co., Ltd (HSA 600:41/01-026/16/41_51) | |
21 Dec 2016 | Philips MX 16-Slice CT Scanner System, Philips Medical Systems (Cleveland), Inc (HSA 600:41/01-026/16/40_40) | |
21 Dec 2016 | Synthes Reamer/Irrigator/Aspirator (RIA) System, Synthes GmbH (HSA 600:41/01-002/16/38_44) | |
19 Dec 2016 | Impactor for PFNA Blade, Synthes GmbH (HSA 600:41/01-002/16/37_35) | |
16 Dec 2016 | UniCel DxC Synchron Wash Concentrate II, Beckman Coulter Inc. (HSA 600:41/01-052/16/13_57) | |
16 Dec 2016 | IMAGER™II ANGIOGRAPHIC CATHETER, Boston Scientific Corporation (HSA 600:41/01-007/16/07_25) | |
15 Dec 2016 | ID-DC-Screening II, DiaMed GmbH (HSA 600:41/01-027/16/15_24) | |
15 Dec 2016 | ID -DiaPanel and ID- DiaPanel P, DiaMed GmbH (HSA 600:41/01-027/16/16_38) | |
15 Dec 2016 | Siemens Biograph mCT & Siemens Biograph mCT Flow, Siemens Medical Solutions USA, Inc (HSA 600:41/01-022/16/55_18) | |
13 Dec 2016 | iPlan RT, iPlan RT Dose and BrainSCAN, BrainLab AG (HSA 600:41/01-047/16/01_17) | |
13 Dec 2016 | Carestation 600 Series Anesthesia Systems, GE Medical Systems China Co., Ltd (HSA 600:41/01-010/16/23_08) | |
12 Dec 2016 | VITROS Chemistry Products UPRO Slides, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-303/16/07_23) | |
12 Dec 2016 | Draeger Oxylog 3000 and Draeger Oxylog 3000 plus, Dragerwerk AG & Co. KGaA (HSA 600:41/01-063/16/04_09) | |
12 Dec 2016 | Nanostim Leadless Cardiac Pacemaker, St Jude Medical Cardiac Rhythm Management Division (HSA 600:41/01-025/16/02_64) | |
10 Dec 2016 | Artis Zee Family System, Artis Q Family System, Siemens Healthcare GmbH (HSA 600:41/01-022/16/54_56) | |
9 Dec 2016 | Smith & Nephew Vulcan Electro RF System (Split Electrode Ground Pad), Smith & Nephew Inc (HSA 600:41/01-073/16/29_48) | |
9 Dec 2016 | BioPlex 2200 ToRC IgM Calibrator Set and Control Set, Clinical Diagnostics Group (HSA 600:41/01-027/16/14_22) | |
8 Dec 2016 | ORTHO VISION Analysers with Software Version 3.6.0 and below, Ortho Clinical Diagnostics (HSA 600:41/01-303/16/06_60) | |
8 Dec 2016 | PreciControl Varia Level 2, Roche Diagnostics GmbH (HSA 600:41/01-016/16/20_61) | |
7 Dec 2016 | Galeo Pro Coronary Guidewire, Concert Medical LLC (HSA 600:41/01-269/16/01_46) | |
7 Dec 2016 | Software EyeSuite Version i.8.2.1.0 in Connection with DICOM, Haag Streit AG (HSA 600:41/01-110/16/04_54) | |
6 Dec 2016 | Claria MRI™ CRT-D SureScan™ and Amplia MRI™ CRT-D SureScan™, Medtronic Inc (HSA 600:41/01-009/16/18_52) | |
5 Dec 2016 | SynReam Flexible Shaft, Flexible Shaft Ø 7.0mm, long, Mathys Medical Ltd (HSA 600:41/01-002/16/36_63) | |
5 Dec 2016 | Abbott ARCHITECT Active-B12 Reagent Kit, Abbott GmbH & Co KG (HSA 600:41/01-005/16/12_58) | |
5 Dec 2016 | Boston Scientific INGEVITY MRI Leads, Boston Scientific Corporation (HSA 600:41/01-007/16/06_44) | |
1 Dec 2016 | CarePlus incubator, Giraffe Exam Light, Giraffe Incubator, Giraffe OmniBed, Giraffe Spot PT, IWS, Panda Warmer, Giraffe Bedded Warmer, Ohmeda Medical (HSA 600:41/01-010/16/22_49) |