Field Safety Notices
Field Safety Notice - Jan 2019
Audiences
Healthcare professional
Industry member
Product type
Medical devices
31 January 2019
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Table caption
Date of Notification | Title | FSN |
|---|---|---|
31 Jan 2019 | WIP'ANIOS PREMIUM and WIP'ANIOS EXCEL, Laboratoires ANIOS (HSA 600:41/01-017/19/01_79) | |
30 Jan 2019 | Specular Microscope CEM-530, Nidek Co., Ltd (HSA 600:41/01-334/19/01_64) | |
30 Jan 2019 | Terumo Needle (Neolus), Terumo (Philippines) Corporation (HSA 600:41/01-028/19/01_35) | HSA 6004101-028-19-01_35_FSN (Revised)_Redacted [PDF, 3375 KB] |
30 Jan 2019 | Minstrel, ArjoHuntleigh AB (HSA 600:41/01-065/19/01_38) | |
29 Jan 2019 | MyLab Ultrasound Probes, Esaote S.p.A. (HSA 600:41/01-288/19/01_48) | |
29 Jan 2019 | Cook Transseptal Needle, Cook Incorporated (HSA 600:41/01-013/19/03_62) | |
29 Jan 2019 | Optetrak Logic CC Stem Extension, 22mm x 160mm, Exactech Inc (HSA 600:41/01-257/19/01_44) | |
28 Jan 2019 | Burr, Oval, 12 Flute, 5.5mm x 13cm, Arthrex Inc. (HSA 600:41/01-333/19/01_76) | |
26 Jan 2019 | Convatec Rectal tube, Mini Vacuum Set, Convatec Limited (HSA 600:41/01-044/19/01_18) | |
24 Jan 2019 | Volcano s5. s5i, CORE and CORE Mobile systems with version 2.5 FFR/iFR software, Volcano Corporation (HSA 600:41/01-070/19/02_66) | |
21 Jan 2019 | Edwards Commander Delivery System, Edwards Lifesciences LLC (HSA 600:41/01‐060/19/01_54) | |
17 Jan 2019 | Percuvance® Percutaneous Shaft 29cm and 36cm, Teleflex Medical (HSA 600:41/01-139/19/01_18) | |
17 Jan 2019 | 2090 CareLinkTM Programmer, 29901 EncoreTM Programmer, and CareLink Network Application Software 2491, Medtronic Inc (HSA 600:41/01-009/19/02_62) | |
15 Jan 2019 | LOGIQ P6 Model BT07 and BT09 Systems, GE Ultrasound Korea, Ltd (HSA 600:41/01-010/19/02_74) | |
15 Jan 2019 | bioMerieux VITEK 2 GN Card; bioMerieux VITEK 2 GP Card; bioMerieux VITEK 2 ANC Card; bioMerieux VITEK 2 Antimicrobial Automated Susceptibility Test, Biomerieux Inc (HSA 600:41/01-146/19/01_70) | |
14 Jan 2019 | Abott Clinical Chemistry Magnesium Assay, Abbott Laboratories (HSA 600:41/01-005/19/01_59) | |
11 Jan 2019 | TEXAS Bronchoscope Tube, Richard Wolf GmbH (HSA 600:41/01-119/19/01_51) | |
11 Jan 2019 | Philips IntelliVue Multi-Measurement Module X3, Philips Medizin Systeme Boblingen GmbH (HSA 600:41/01-010/19/01_46) | |
11 Jan 2019 | Centricity Universal Viewer (UV) Workstation, GE Healthcare (HSA 600:41/01-010/19/01_46) | |
10 Jan 2019 | ThermoScientificTM OxoidTM Meropenem 32 M.I.C.E. Strip, Oxoid Limited (Thermo Fisher Scientific), (HSA 600:41/01-178/19/01_57) | |
9 Jan 2019 | Eclipse Treatment Planning System, Varian Medical Systems, Inc. (HSA 600:41/01-058/19/01_43) | |
9 Jan 2019 | SL PLUS MIA Double Offset Adapter. RT 60/25MM, Smith & Nephew Orthopaedics AG (HSA 600:41/01-073/19/01_35) | |
8 Jan 2019 | BD Phoenix AST Indicator Solution, Becton Dickinson and Company (BD) (HSA 600:41/01-003/19/01_23) | |
8 Jan 2019 | Mako Onlay Insert Extractor, Mako Surgical Corp. (HSA 600:41/01-070/19/01_66) | |
7 Jan 2019 | Xper Flex Cardio Patient Monitoring System, INVIVO, a division of Philips Medical Systems (HSA 600 41/01-026/19/01_77) | |
7 Jan 2019 | Bonesupport AB Cerament Bone Void Filler, Bonesupport AB (HSA 600:41/01-332/19/01_50) | |
7 Jan 2019 | PHILIPS PAGEWRITER TC CARDIOGRAPHS (TC20/30/50/70), Philips Medical Systems (HSA 600:41/01-026/19/02_51) | |
7 Jan 2019 | COOK Captura Disposable Biopsy Forceps, Wilson-Cook Medical, Inc. (HSA 600:41/01-013/19/02_38) | |
4 Jan 2019 | Universa Ureteral Stent Set, C-Flex DP Ureteral Stent Set, Roadrunner Wire Guides, Urethral Dilator Set, Wire Guide, Cook Incorporated (HSA 600:41/01-013/19/01_71) | |
21Dec 2018 | da Vinci Harmonic ACE Insert, Intuitive Surgical, Inc. (HSA 600:41/01-070/18/27_38) | HSA 6004101-070-18-27_38 FSN (v2) [PDF, 135 KB] This FSN is an update to the original FSN published in Dec 2018. |
7 Nov2018 | Nellix® EndoVascular Aneurysm Sealing System, Endologix International Holdings B.V.(HSA 600:41/01-329/18/01_52) | HSA 6004101-329-18-01_52 FSN_Redacted [PDF, 39 KB] This FSN is an update to the original FSN published in Nov 2018. |
27 Sep 2018 | buddy™ Disposable Set, Belmont Instrument Corporation (HSA 600:41/01-070/18/20_63) | HSA 6004101-070-18-20_63 FSN Corrected_Redacted [PDF, 186 KB] This updated FSN replaces the original FSN published in Sep 2018. |