Field Safety Notices
Field Safety Notice - Feb 2019
28 February 2019
Audiences
Healthcare professional
Industry member
Product-type
Medical devices
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Table caption
Date of Notification | Title | FSN |
|---|---|---|
28 Feb 2019 | Autolith Touch EHL Extender Cable, Northgate (HSA 600:41/01-007/19/01_71) | HSA 6004101-007-19-01_71 FSN_Redacted [PDF, 167 KB] (opens in new tab) |
28 Feb 2019 | Model 37751 Rechargers, Medtronic Inc (HSA 600:41/01-009/19/03_66) | HSA 6004101-009-19-03_66 FSN_Redacted [PDF, 170 KB] (opens in new tab) |
27 Feb 2019 | Philips BV Vectra, Philips India Limited (HSA 600:41/01-026/19/06_79) | HSA 6004101-026-19-06_79 FSN_Redacted [PDF, 1443 KB] (opens in new tab) |
26 Feb 2019 | CELL‐DYN EMERALD, Abbott Laboratories (HSA 600:41/01-005/19/05_57) | HSA 6004101-005-19-05_57 FSN_Redacted [PDF, 110 KB] (opens in new tab) |
26 Feb 2019 | SpeedLock PEEK 3.4mm Knotless Fixation Device, ArthroCare Corporation (HSA 600:41/01-073/19/04_46) | HSA 6004101-073-19-04_46 FSN [PDF, 163 KB] (opens in new tab) |
26 Feb 2019 | Philips MultiDiagnost-Eleva with Flat Detector; Allura Xper systems, Philips Medical Systems Nederland BV (HSA 600:41/01-026/19/05_62) | HSA 6004101-026-19-05_62 FSN_Redacted [PDF, 295 KB] (opens in new tab) |
26 Feb 2019 | Baha 5 Sound Processor Tamper-proof Battery Door 3pcs, Cochlear Bone Anchored Solutions AB (HSA 600:41/01-171/19/01_18) | HSA 6004101-171-19-01_18 FSN [PDF, 173 KB] (opens in new tab) |
26 Feb 2019 | Covidien Force TriVerse™ Electrosurgical Device (10' cord), Covidien llc (HSA 600:41/01-046/19/01_68) | HSA 6004101-046-19-01_68 FSN_Redacted [PDF, 243 KB] (opens in new tab) |
25 Feb 2019 | Inferior Vena Cava (IVC) Filter, William Cook Europe ApS (HSA 600:41/01-013/19/04_46) | HSA 6004101-013-19-04_46 FSN_Redacted [PDF, 325 KB] (opens in new tab) |
25 Feb 2019 | CELL-DYN Emerald 22 AL, Abbott Laboratories Diagnostics Division (HSA 600:41/01-005/19/04_31) | HSA 6004101-005-19-04_31 FSN_Redacted [PDF, 102 KB] (opens in new tab) |
22 Feb 2019 | ICU Medical ChemoClave Closed Vial Spike, ICU Medical Inc (HSA 600:41/01-145/19/01_52) | HSA 6004101-145-19-01_52 FSN_Redacted [PDF, 995 KB] (opens in new tab) |
22 Feb 2019 | SmartStitch PerfectPasser Connector, ArthroCare Corporation (HSA 600:41/01-073/19/03_68) | HSA 6004101-073-19-03_68 FSN [PDF, 86 KB] (opens in new tab) |
21 Feb 2019 | Philips InteIliVue MX40, Philips Medical Systems (HSA 600:41/01-026/19/04_64) | HSA 6004101-026-19-04_64 FSN_Redacted [PDF, 1155 KB] (opens in new tab) |
21 Feb 2019 | ARIES® HSV 1&2 Assay (50-10017), ARIES® Extraction Kit (50-10026), Luminex Coporation (HSA 600:41/01-033/19/03_59) | HSA 6004101-033-19-03_59_FSN [PDF, 616 KB] (opens in new tab) |
19 Feb 2019 | DIASPECT HEMOGLOBIN T-LOW ANALYZER, Diaspect Medical GmbH (HSA 600:41/01-033/19/02_67) | HSA 6004101-033-19-02_67 FSN_Redacted [PDF, 13909 KB] (opens in new tab) |
19 Feb 2019 | COMBIVISC and COMBIVISC MULTIPACK 5-PACK, Z-HYALCOAT MULTIPACK 10-PACK, Hyaltech Ltd (HSA 600:41/01-136/19/01_50) | HSA 6004101-136-19-01_50 FSN_Redacted [PDF, 1012 KB] (opens in new tab) |
15 Feb 2019 | xTAG Gastrointestinal Panel, Luminex Molecular Diagnostics Inc (HSA 600:41/01-148/19/02_61) | HSA 6004101-148-19-02_61 FSN_Redacted [PDF, 152 KB] (opens in new tab) |
15 Feb 2019 | ARIES HSV 1&2 Assay, ARIES Bordetella Assay, ARIES Extraction Kit, Luminex Corporation (HSA 600:41/01-148/19/01_61) | HSA 6004101-148-19-01_61 FSN_Redacted [PDF, 5718 KB] (opens in new tab) |
15 Feb 2019 | Modular Head Disimpactor, Adler Mediequip Pvt Ltd (HSA 600:41/01-073/19/02_63) | HSA 6004101-073-19-02_63 FSN [PDF, 83 KB] (opens in new tab) |
15 Feb 2019 | LIFEPAK 15 Monitor/Defibrillators, Physio Control (HSA 600:41/01-056/19/01_63) | HSA 6004101-056-19-01_63 FSN_Redacted [PDF, 110 KB] (opens in new tab) |
13 Feb 2019 | Alinity hq Analyzer, Abbott GmbH & Co. KG (HSA 600:41/01-005/19/03_78) | HSA 6004101-005-19-03_78 FSN [PDF, 319 KB] (opens in new tab) |
11 Feb 2019 | ARCHITECT Estradiol Reagent Kit and Alinity i Estradiol Reagent Kit, Abbott GmbH & Co. KG, Abbott Ireland Diagnostics Division (HSA 600:41/01-005/19/02_73) | HSA 6004101-005-19-02_73 FSN [PDF, 308 KB] (opens in new tab) |
11 Feb 2019 | Elecsys Anti-HAV IgM, Roche Diagnostics GmbH (HSA 600:41/01-016/19/01_75) | HSA 6004101-016-19-01_75 FSN [PDF, 94 KB] (opens in new tab) |
07 Feb 2019 | ADVIA Chemistry XPT Sample Probe Cover for Aptio by Siemens, Aptio by Inpeco and FlexLab Automation Interfaces, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/19/02_49) | HSA 6004101-022-19-02_49 FSN [PDF, 92 KB] (opens in new tab) |
04 Feb 2019 | SPD Clearblue Digital Home Ovulation Test 10s, SPD Swiss Precision Diagnostics GmbH (HSA 600:41/01-277/19/01_31) | HSA 6004101-277-19-01_31 FSN_Redacted [PDF, 532 KB] (opens in new tab) |
01 Feb 2019 | Senographe Crystal Nova, GE Ultrasound Korea Ltd (HSA 600:41/01-010/19/03_52) | HSA 6004101-010-19-03_52 FSN_Redacted [PDF, 132 KB] (opens in new tab) |
01 Feb 2019 | UNISEPTA FOAM 2 WIPES, USF Healthcare S.A. (HSA 600:41/01-335/19/01_44) | HSA 6004101-335-19-01_44 FSN_Redacted [PDF, 526 KB] (opens in new tab) |
21 Dec 2018 | da Vinci Harmonic ACE Insert, Intuitive Surgical, Inc. (HSA 600:41/01-070/18/27_38) | HSA 6004101-070-18-27_38 FSN [PDF, 166 KB] (opens in new tab) This FSN is an update to the original FSN published in Dec 2018. |