Field Safety Notices
Field Safety Notice - Oct 2018
Audiences
Healthcare professional
Industry member
Product type
Medical devices
31 October 2018
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Table caption
Date of Notification | Title | FSN |
|---|---|---|
29 Oct 2018 | Philips Brillance Computed Tomography X-Ray System, Philips Medical Systems (Cleveland), Inc. (HSA 600:41/01-026/18/30_76) | HSA 6004101-026-18-30_76 FSN_Redacted [PDF, 1650 KB] (opens in new tab) |
29 Oct 2018 | Strata MR Adjustment Tools, Medtronic Inc (HSA 600:41/01-009/18/20_38) | HSA 6004101-009-18-20_38 FSN_Redacted [PDF, 1364 KB] (opens in new tab) |
29 Oct 2018 | Medtronic StealthStation® S7TM Treatment Guidance System, Medtronic (HSA 600:4101/009/18/21_79) | HSA 6004101-009-18-21_79 FSN_Redacted [PDF, 924 KB] (opens in new tab) |
29 Oct 2018 | ACCESS hsTnI Reagent, IMMUNOTECH S.A.S (HSA 600:41/01-052/18/06_31) | HSA 6004101-052-18-06_31 FSN_Redacted [PDF, 141 KB] (opens in new tab) |
28 Oct 2018 | Vanguard PS Open Box Femorals, Biomet Orthopaedics (HSA 600:41/01-008/18/15_54) | HSA 6004101-008-18-15_54 FSN_Redacted [PDF, 133 KB] (opens in new tab) |
28 Oct 2018 | Various Trauma Guide Wires, Zimmer Inc (HSA 600:41/01‐008/18/16_54) | HSA 6004101-008-18-16_54 FSN Redacted [PDF, 202 KB] (opens in new tab) |
26 Oct 2018 | IH-QC3, DiaMed GmbH (HSA 600:41/01-027/18/13_61) | HSA 6004101-027-18-13_61 FSN_Redacted [PDF, 2596 KB] (opens in new tab) |
25 Oct 2018 | Stockert Heater‐Cooler System 3T, Stockert Heater‐Cooler S3 WKS2, LivaNova Deutschland GmbH (HSA 600:41/01-299/18/02_48) | HSA 6004101-299-18-02_48 FSN_Redacted [PDF, 336 KB] (opens in new tab) |
24 Oct 2018 | PLEX ELITE 9000, Carl Zeiss Meditec Inc. (HSA 600:41/01-136/18/02_18) | HSA 6004101-136-18-02_18 FSN_Redacted [PDF, 2605 KB] (opens in new tab) |
23 Oct 2018 | VITROS® Immunodiagnostic Products Vitamin B12 Reagent Pack ½, Ortho-Clinical Diagnostics (HSA 600:41/01-303/18/16_69) | HSA 6004101-303-18-16-69 FSN [PDF, 108 KB] (opens in new tab) |
23 Oct 2018 | Ortho-Clinical VITROS 3600 Immunodiagnostic System, Ortho-Clinical Diagnostics, Inc. (HSA 600:41/01-303/18/15_70) | HSA 6004101-303-18-15_70 FSN [PDF, 159 KB] (opens in new tab) |
23 Oct 2018 | VITROS 4600 Chemistry System, VITROS 5600 Integrated System, VITROS XT 7600 Integrated System and VITROS 5,1 FS Chemistry System, Ortho-Clinical Diagnostics, Inc., ORTHO-Clinical Diagnostics Singapore Pte. Ltd, (HSA 600:41/01-303/18/14_78) | HSA 6004101-303-18-14_78 FSN [PDF, 253 KB] (opens in new tab) |
19 Oct 2018 | ICHEM VELOCITY URINE CHEMISTRY STRIPS, IRIS International Inc. (HSA 600:41/01-052/18/05_57) | HSA 6004101-052-18-05_57 FSN_Redacted [PDF, 163 KB] (opens in new tab) |
19 Oct 2018 | Philips CombiDiagnost R90, Philips Medical Systems (HSA 600:41/01-026/18/29_77) | HSA 6004101-026-18-29_77_Redacted [PDF, 3030 KB] (opens in new tab) |
18 Oct 2018 | Leica M525 F20 Microscope System, Leica Instruments (Schweiz) AG (HSA 600:41/01-126/18/04_46) | HSA 6004101-126-18-04_46 FSN [PDF, 614 KB] (opens in new tab) |
17 Oct 2018 | Philips HeartStart FR3 AED, Philips Medical Systems (HSA 600:41/01-026/18/28_43) | HSA 6004101-026-18-28_43 FSN_Redacted [PDF, 1516 KB] (opens in new tab) |
17 Oct 2018 | VITEK® 2 Antimicrobial Susceptibility Testing (AST), BioMerieux Inc. (HSA 600:41/01-146/18/09_59) | HSA 6004101-146-18-09_59 FSN_Redacted [PDF, 403 KB] (opens in new tab) |
16 Oct 2018 | Codan Filter, Codan US Corporation (HSA 600:41/01-069/18/02_43) | HSA 6004101-069-18-02_43 FSN_Redacted [PDF, 179 KB] (opens in new tab) |
16 Oct 2018 | Covidien Parietex™ Composite Parastomal Mesh, Sofradim Production (HSA 600:41/01-046/18/11_68) | HSA 6004101-046-18-11_68 FSN_Redacted [PDF, 516 KB] (opens in new tab) |
15 Oct 2018 | ALINITY I FREE T3 REAGENT KIT AND ALINITY I TOTAL T3 REAGENT KIT, Abbott Ireland Diagnostics Division (HSA 600:41/01-005/18/23_67) | HSA 6004101-005-18-23_67 FSN [PDF, 228 KB] (opens in new tab) |
15 Oct 2018 | ePTFE Small Beading Vascular Graft products, Bard Peripheral Vascular, Inc (HSA 600:41/01-050/18/06_51) | HSA 6004101-050-18-06_51 FSN_Redacted [PDF, 2832 KB] (opens in new tab) |
15 Oct 2018 | ARCHITECT Free T3 Reagent Kit, ARCHITECT Total T3 Reagent Kit, Abbott Ireland Diagnostics Division (HSA 600:41/01-005/18/22_69) | HSA 6004101-005-18-22-69 FSN version [PDF, 231 KB] (opens in new tab) |
12 Oct 2018 | Alinity hq Analyzer and Alinity hs Slide Maker Strainer Module, Abbott GmbH & Co. KG (HSA 600:41/01-005/18/21_34) | HSA 6004101-005-18-21_34 FSN [PDF, 136 KB] (opens in new tab) |
12 Oct 2018 | Dual Pump Pack OPO73, Johnson & Johnson Surgical Vision Inc. (JJSV) Santa Ana, CA (HSA 600:41/01-018/18/02_66) | HSA 6004101-018-18-02_66 FSN_Redacted [PDF, 117 KB] (opens in new tab) |
12 Oct 2018 | Infinity™ DBS 8-Channel Directional Lead, St. Jude Medical (HSA 600:41/01-005/18/20_35) | HSA 6004101-005-18-20_35 FSN_Redacted [PDF, 336 KB] (opens in new tab) |
09 Oct 2018 | NUCLISENS® Lysis Buffer, Biomerieux S.A. (HSA 600:41/01-146/18/08_61) | HSA 6004101-146-18-08_61 FSN [PDF, 278 KB] (opens in new tab) |
09 Oct 2018 | VITROS® CHEMISTRY PRODUCTS DLDL REAGENT, Ortho-Clinical Diagnostics, Inc. (HSA 600:41/01-303/18/13_75) | HSA 6004101-303-18-13_75 FSN [PDF, 346 KB] (opens in new tab) |
08 Oct 2018 | Siemens Evo Excel, Simens Medical Solutions USA, Inc. Molecular Imaging (HSA 600:41/01-022/18/28_77) | HSA 6004101-022-18-28_77 FSN_Redacted [PDF, 522 KB] (opens in new tab) |
08 Oct 2018 | Giraffe OmniBed, Ohmeda Medical (a division of Datex Ohmeda) (HSA 600:41/01-010/18/24_50) | HSA 6004101-010-18-24_50 FSN_Redacted [PDF, 490 KB] (opens in new tab) |
05 Oct 2018 | MiniMed™ 640G, Medtronic MiniMed (HSA 600:41/01-009/18/19_63) | HSA 6004101-009-18-19_63 FSN_Redacted [PDF, 224 KB] (opens in new tab) |
05 Oct 2018 | Philips Prodiva MRI System, Philips Healthcare (Suzhou) Co. Ltd(HSA 600:41/01-026/18/27_37) | HSA 6004101-026-18-27_37 FSN [PDF, 55 KB] (opens in new tab) |
05 Oct 2018 | GENESIS II Distal Femoral Cutting Block, Smith & Nephew, Inc.(HSA 600:41/01-073/18/18_38) | HSA 6004101-073-18-18_38 FSN [PDF, 78 KB] (opens in new tab) |
04 Oct 2018 | Giraffe Omnibed Carestation, Giraffe incubator Carestation, Giraffe Warmer, Panda iRes Warmer, Panda Freestanding Warmer and Panda Wall mount, Ohmeda Medical (a division of Datex Ohmeda)(HSA 600:41/01-010/18/23_38) | HSA 6004101-010-18-23_38 FSN_Redacted [PDF, 415 KB] (opens in new tab) |
04 Oct 2018 | Medtronic CareLink 2090 Programmer & Medtronic CareLink Encore Programmer, Medtronic Inc (HSA 600:41/01-009/18/18_71) | HSA 6004101-009-18-18_71 FSN_Redacted [PDF, 867 KB] (opens in new tab) |
04 Oct 2018 | Artis Zee Family System and Artis Q Family System, Siemens Healthcare GmbH (HSA 600:41/01-022/18/27_76) | HSA 6004101-022-18-27_76 FSN_Redacted [PDF, 1597 KB] (opens in new tab) |
03 Oct 2018 | Triathlon TS Augments Sizes 3 and 6, Howmedica Ostenics Corp(HSA 600:41/01-014/18/08_71) | HSA 6004101-014-18-08_71 FSN_Redacted [PDF, 138 KB] (opens in new tab) |
03 Oct 2018 | Medtronic O-arm® O2 Imaging System, Medtronic Navigation, Inc (Littleton)(HSA 600:41/01-009/18/17_18) | HSA 6004101-009-18-17_18 FSN_Redacted [PDF, 499 KB] (opens in new tab) |
03 Oct 2018 | DigitalDiagnost systems with system software versions 4.1.x or 4.2.x and stitching license, DigitalDiagnost systems with system software versions 4.1.8 and 4.2.5, Philips Medical Systems (HSA 600:41/01-026/18/26_46) | HSA 6004101-026-18-26_46 FSN [PDF, 499 KB] (opens in new tab) |
02 Oct 2018 | RAPIDPoint® 500 Blood Gas Analyzer, Siemens Healthcare Diagnostics, Inc. (HSA 600:41/01-022/18/26_73) | HSA 6004101-022-18-26_73 FSN [PDF, 309 KB] (opens in new tab) |
02 Oct 2018 | Abbott ARCHITECT HAVAb-IgG Assay, Abbott ARCHITECT HAVAb-IgM Assay, Abbott Alinity I HAVAb IgG, Abbott GmbH & Co. KG(HSA 600:41/01-005/18/19_70) | HSA 6004101-005-18-19_70 FSN [PDF, 289 KB] (opens in new tab) |
01 Oct 2018 | Biograph mCT and Biograph Horizon systems, Siemens Medical Solutions USA, Inc.(HSA 600:41/01-022/18/25_43) | HSA 6004101-022-18-25_43 FSN_Redacted [PDF, 876 KB] (opens in new tab) |
13 Aug 2018 | Hematek Wright Giemsa Stain Pak and Hematek Modified Wright Stain Pak, Siemens Healthcare Diagnostics Inc. (HSA 600:41/01-022/18/20_49) | HSA 6004101-022-18-20_49 FSN [PDF, 149 KB] (opens in new tab) This FSN is an update to the original FSN published in Aug 2018. |