Field Safety Notices
Field Safety Notice - Oct 2015
Audiences
Healthcare professional
Industry member
Product type
Medical devices
31 October 2015
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Table caption
Date of Notification | Title | FSN |
|---|---|---|
29 Oct 2015 | Access CEA Reagent Kit, Beckman Coulter Inc (HSA 600:41/01-052/15/09_38) | |
27 Oct 2015 | Revolution CT Scanners, GE Medical Systems LLC (HSA 600:41/01-010/15/21_56) | |
27 Oct 2015 | Synchron Systems Enzymatic Creatinine (CR-E) and Uric Acid (URIC) Reagents, Beckman Coulter Inc (HSA 600:41/01-052/15/08_34) | |
26 Oct 2015 | TheraSphere Y-90 Glass Microspheres Injection, Biocompatibles UK Ltd (HSA 600:41/01-263/15/03_48) | |
23 Oct 2015 | Stryker 2-Stage and 3-Stage I.V. Poles, Stryker Medical (HSA 600:41/01-014/15/13_54) | |
23 Oct 2015 | VariSource™ iX Control Software, Varian Medical Systems (HSA 600:41/01-058/15/03_46) | |
23 Oct 2015 | Amphirion® Deep Percutaneous Transluminal Angioplasty (PTA) Balloon Dilation Catheter, Invatec S.p.A (HSA 600:41/01-009/15/16_55) | |
22 Oct 2015 | GENESIS II Constrained Articular Insert, Smith & Nephew Inc, Smith & Nephew Inc (HSA 600:41/01-073/15/09_53) | |
19 Oct 2015 | Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer, GE Healthcare (HSA 600:41/01-010/15/19_41) | |
19 Oct 2015 | Centricity PACS-IW, GE Healthcare (HSA 600:41/01-010/15/20_51) | |
19 Oct 2015 | chronOS Inject Bone Void Filler, Synthes GmbH (HSA 600:41/01-002/15/46_49) | |
19 Oct 2015 | Welch Allyn KleenSpec® Corded Illumination System, Welch Allyn Inc. (HSA 600:41/01-006/15/01_52) | |
19 Oct 2015 | HOYA Preloaded iSert Intraocular lenses (IOLs), HOYA Corporation Inc (HSA 600:41/01-206/15/01_36) | |
16 Oct 2015 | Sydney IVF PVP (K-SIPV), William A Cook Australia Pty Ltd (HSA 600:41/01-013/15/05_37) | |
16 Oct 2015 | Philips Pinnacle 3 Radiation Therapy Planning System, Philips Medical Systems (Cleveland) Inc (HSA 600:41/01-026/15/34_35) | |
16 Oct 2015 | Unitek Victory Mini Tube Lower Left Buccal Tube, 3M Unitek Corporation (HSA 600:41/01-031/15/02_33) | |
15 Oct 2015 | iPlan RT Image (below v4.1.2) / iPlan RT, BrainLab AG (HSA 600:41/01-047/15/08_19) | |
14 Oct 2015 | ORTHO BioVue® System Cassettes, Ortho-Clinical Diagnostics, Inc (HSA 600:41/01-002/15/45_22) | |
14 Oct 2015 | ARIA® for Radiation Oncology, ARIA® Oncology Information System for Radiation Oncology, Varian Medical Systems, Inc. (HSA 600:41/01-058/15/02_48) | |
14 Oct 2015 | Allura Xper FD, Philips Medical Systems Nederland B.V. (HSA 600:41/01-026/15/32_56) | |
14 Oct 2015 | Silimed Implants, Silimed Industria De Implantes Ltda (HSA 600:41/01-284/15/01_12) | |
14 Oct 2015 | Giraffe Shuttle, Ohmeda Medical (HSA 600:41/01-010/15/17_17) | |
14 Oct 2015 | Philips HeartStart MRx Defibrillator/Monitor, Philips Medical Systems (HSA 600:41/01-026/15/33_29) | |
14 Oct 2015 | MR Surgical Suite II MR system, GE Medical Systems LLC (HSA 600:41/01-010/15/18_25) | |
13 Oct 2015 | Biosense Webster CARTOSOUND Module in conjunction with SOUNDSTAR eco 8F and eco 10F catheters, Biosense Webster Inc (HSA 600:41/01-002/15/44_46) | |
12 Oct 2015 | ADVIA Chemistry XPT system, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/15/54_61) | |
12 Oct 2015 | Urinary Metanephrines by HPLC, Bio-Rad Laboratories GmbH (HSA 600:41/01-027/15/03_23) | |
12 Oct 2015 | Amicus Cell Separator, Fresenius Kabi AG (HSA 600:41/01-020/15/02_45) | |
12 Oct 2015 | Duracon Tibial Wedge Augments, Howmedica Osteonics Corp (HSA 600:41/01-014/15/12_54) | |
07 Oct 2015 | STERRAD® NX® Sterilization System, Advanced Sterilization Products (HSA 600:41/01-002/15/42_52) | |
07 Oct 2015 | ORTHO VISION™ Analyzer for ORTHO BioVue® Cassette, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-002/15/43_59) | |
07 Oct 2015 | MiniMed® 640G Insulin pump, Medtronic Minimed (HSA 600:41/01-009/15/15_44) | |
07 Oct 2015 | Triathlon MIS Modular Distal Capture, Howmedica Osteonics Corp (HSA 600:41/01-014/15/11_53) | |
06 Oct 2015 | Exeter Small Tapered Pin Reamer and Exeter Large Tapered Pin Reamer, Howmedica Osteonics Corp (HSA 600:41/01-014/15/10_51) | |
05 Oct 2015 | HARMONIC ACE+7 Shears with Advanced Haemostasis, Ethicon Endo-Surgery LLC (HSA 600:41/01-002/15/41_50) | |
02 Oct 2015 | Medtronic Navigated Solera Screwdrivers, Medtronic Navigation Inc (HSA 600:41/01-009/15/14_36) | |
02 Oct 2015 | Brilliance 16-Slice (Air)/ 64 CT/ CT Big Bore, Ingenuity Core/ Ingenuity Core^128/ Flex, Philips Medical Systems Inc (HSA 600:41/01-026/15/31_37) | |
02 Oct 2015 | Narrow Right Angle Large Driver Tip and Narrow Right Angle Square Driver Tip, Biomet 3i (HSA 600:41/01-181/15/01_35) | |
01 Oct 2015 | Sciatic Nerve Retractors, Synthes GmbH (HSA 600:41/01-002/15/39_29) | |
01 Oct 2015 | VITROS® Chemistry Products Calibrator Kit 9, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-002/15/40_57) | |
01 Oct 2015 | ConforMIS iTotal Knee Replacement Systems, ConforMIS Inc (HSA 600:41/01-263/15/02_33) |