Field Safety Notices
Field Safety Notice - Jan 2018
Audiences
Healthcare professional
Industry member
Product type
Medical devices
31 January 2018
This article has been migrated from an earlier version of the site and may display formatting inconsistencies.
Table caption
Date of Notification | Title | FSN |
|---|---|---|
30 Jan 2018 | Philips SureSigns VSi, SureSigns VS2+ Vital Signs Monitor, Philips Medical Systems (HSA 600:41/01-026/18/07_18) | HSA 6004101-026-18-07_18 FSN_Redacted [PDF, 33 KB] (opens in new tab) |
30 Jan 2018 | Acuson SC2000 Ultrasound System, Siemens Medical Solutions USA, Inc (HSA 600:41/01-022/18/03_56) | HSA 6004101-022-18-03_56 FSN [PDF, 110 KB] (opens in new tab) |
29 Jan 2018 | Philips Avent uGrow Smart Ear Thermometer, SCH740, Philips Consumer Lifestyle B.V (HSA 600:41/01-026/18/05_51) | HSA 6004101-026-18-05_51 FSN [PDF, 1348 KB] (opens in new tab) |
26 Jan 2018 | Philips HeartStart MRx and FR3 Monitor/Defibrillator and HeartStart FR3 AED Used With Q-CPR Meter or CPR Sensor, Philips Medical Systems (HSA 600:41/01-026/18/06_46) | HSA 6004101-026-18-06_46 FSN [PDF, 86 KB] (opens in new tab) |
26 Jan 2018 | C/M HUMERAL ASSEMBLY 4’’ XSMALL, Zimmer Inc. (HSA 600:41/01-008/18/02_46) | HSA 6004101-008-18-02_46 FSN [PDF, 71 KB] (opens in new tab) |
26 Jan 2018 | Medtronic O-Arm Imaging System, Medtronic Inc (HSA 600:41/01-009/18/01_50) | HSA 6004101-009-18-01_50 FSN_Redacted [PDF, 1318 KB] (opens in new tab) |
24 Jan 2018 | ORTHOSCAN MOBILE DI; ORTHOSCAN FD-OR; ORTHOSCAN FD PULSE, Orthoscan Inc. (HSA 600:41/01-215/18/01_44) | HSA 6004101-215-18-01_44 FSN [PDF, 264 KB] (opens in new tab) |
24 Jan 2018 | ProGrade 1x, Philips Medical System DMC GmbH (HSA 600:41/01-026/18/04_40) | HSA 6004101-026-18-04_40 FSN_Redacted [PDF, 2403 KB] (opens in new tab) |
24 Jan 2018 | Terumo Advanced Perfusion System 1: Flowmeter Module [802018], Terumo Cardiovascular Systems Corporation (HSA 600:41/01-028/18/02_50) | HSA 6004101-028-18-02_50 FSN_Redacted [PDF, 122 KB] (opens in new tab) |
23 Jan 2018 | bioMerieux Etest Antimicrobial Susceptibility Testing, bioMerieux S.A. (HSA 600:41/01-146/18/02_60) | HSA 6004101-146-18-02_60 FSN [PDF, 413 KB] (opens in new tab) |
22 Jan 2018 | Truvidia Wireless Receiver, TRUMPF Medizin Systeme GmbH + Co. KG (HSA 600:41/01-182/18/01_45) | HSA 6004101-182-18-01_45 FSN_Redacted [PDF, 91 KB] (opens in new tab) |
22 Jan 2018 | Mako RIO System - Ethernet to Fiber Optic Converter, MAKO Surgical Corp. (HSA 600:41/01-070/18/01_35) | HSA 6004101-070-18-01_35 FSN_Redacted [PDF, 110 KB] (opens in new tab) |
22 Jan 2018 | Iqon Spectral CT Version 4.7.2, Philips Medical Systems (Cleveland), Inc. (HSA 600:41/01-026/18/03_37) | HSA 6004101-026-18-03_37 FSN_1_Redacted [PDF, 2877 KB] (opens in new tab) |
22 Jan 2018 | Mako Onlay Insert Extractor, MAKO Surgical Corp. (HSA 600:41/01-070/18/02_25) | HSA 6004101-070-18-02_25 FSN_Redacted [PDF, 109 KB] (opens in new tab) |
19 Jan 2018 | VITROS® Immunodiagnostic Products TSH Reagent Packs, Ortho-Clinical Diagnostics (HSA 600:41/01-303/18/02_59) | HSA 6004101-303-18-02_59 FSN_Redacted [PDF, 152 KB] (opens in new tab) |
17 Jan 2018 | BD Phoenix NMIC panel/NMIC/ID panel, Becton Dickinson and Company (HSA 600:41/01-003/18/01_59) | HSA 6004101-003-18-01_59 FSN [PDF, 225 KB] (opens in new tab) |
17 Jan 2018 | Medfusion® Syringe Pump Model Series 3500 and 4000, Smiths Medical ASD, Inc (HSA 600:41/01-017/18/01_25) | HSA 6004101-017-18-01_25 FSN_Redacted [PDF, 185 KB] (opens in new tab) |
17 Jan 2018 | Triathlon TS Baseplates Sizes 3 and 4, Howmedica Ostenics Corp (HSA 600:41/01-014/18/02_44) | HSA 6004101-014-18-02_44 FSN [PDF, 30 KB] (opens in new tab) |
17 Jan 2018 | Artis One system, Siemens Shenzhen Magnetic Resonance Ltd (HSA 600:41/01-022/18/02_18) | HSA 6004101-022-18-02_18 FSN_Redacted [PDF, 1383 KB] (opens in new tab) |
17 Jan 2018 | Andago Handrails, Hocoma AG (HSA 600:41/01-286/18/01_48) | HSA 6004101-286-18-01_48 FSN_Redacted [PDF, 2884 KB] (opens in new tab) |
16 Jan 2018 | LEGION RK/HK HEMI SZ 3-4 LTMD/RTLA 5MM, Smith & Nephew Inc. (HSA 600:41/01-073/18/01_64) | HSA 6004101-073-18-01_64 FSN [PDF, 175 KB] (opens in new tab) |
16 Jan 2018 | SIGMA HP PFJ Cemented Trochlear Implants, DePuy Orthopaedics, Inc. (HSA 600:41/01-002/18/01_71) | HSA 6004101-002-18-01_71 FSN_Redacted [PDF, 216 KB] (opens in new tab) |
11 Jan 2018 | 8.0MM X 90MM DRI-LOK THREADED CANNULA, Stryker Endoscopy (HSA 600:41/01-014/18/01_43) | HSA-6004101-014-18-01_43 FSN_Redacted [PDF, 133 KB] (opens in new tab) |
10 Jan 2018 | CARESCAPE Central Station (CSCS) software version 2.0.2, GE Medical Systems Information Technologies (HSA 600:41/01-010/18/01_64) | HSA 6004101-010-18-01_64 FSN_Redacted [PDF, 302 KB] (opens in new tab) |
09 Jan 2018 | Ortho Clinical VITROS Chemistry Products VANC Reagent; Ortho Clinical Diagnostics VITROS Chemistry Products ASO Reagent, Ortho-Clinical Diagnostics Inc (HSA 600:41/01-303/18/01_70) | HSA-6004101-303-18-01_70 FSN_Redacted [PDF, 468 KB] (opens in new tab) |
09 Jan 2018 | 5214 Maquet Volista StanOP, Triop and Access cupolas, Maquet SAS (HSA 600:41/01-081/18/01_62) | HSA 6004101-081-18-01_62 FSN [PDF, 1655 KB] (opens in new tab) |
08 Jan 2018 | Vascutek Gelatin Sealed Products, Vascutek Ltd (HSA 600:41/01-028/18/01_48) | HSA 6004101-028-18-01_48 FSN_Redacted [PDF, 943 KB] (opens in new tab) |
08 Jan 2018 | Philips IntelliVue Information Center (PIIC) iX, Philips Medical Systems (HSA 600:41/01-026/18/02_56) | HSA 6004101-026-18-02_56 FSN_Redacted [PDF, 113 KB] (opens in new tab) |
08 Jan 2018 | BIOPLEX INSTRUMENT DETECTOR CLEAN PACK, Bio-Rad Laboratories, Inc (HSA 600:41/01-027/18/01_57) | HSA-6004101-027-18-01_57 FSN [PDF, 648 KB] (opens in new tab) |
05 Jan 2018 | Human Fetal Hemoglobin FITC Conjugate, Life Technologies Corporation (HSA 600:41/01-220/18/01_34) | HSA 6004101-220-18-01_34 FSN [PDF, 43 KB] (opens in new tab) |
05 Jan 2018 | mini VIDAS and VIDAS, BioMerieux S.A. (HSA 600:41/01-146/18/01_31) | HSA 6004101-146-18-01_31 FSN_Redacted [PDF, 243 KB] (opens in new tab) |
05 Jan 2018 | Cyclosporine, DHEA-SO4, Folate and HBc IgM Assays, Siemens Healthcare Diagnostics Inc (HSA 600:41/01-022/18/01_38) | HSA 6004101-022-18-01_38 FSN [PDF, 105 KB] (opens in new tab) |
05 Jan 2018 | Trabecular Metal Stems, Zimmer Inc. (HSA 600:41/01-008/18/01_35) | HSA 6004101-008-18-01_35 FSN_Redacted [PDF, 101 KB] (opens in new tab) |
04 Jan 2018 | Philips Brilliance Computed Tomography X-Ray System, Philips Medical Systems Inc (HSA 600:41/01-026/18/01_43) | HSA 6004101-026-18-01_43 FSN_Redacted [PDF, 788 KB] (opens in new tab) |
03 Jan 2018 | W & H Implantmed Surgical Drive Unit, W&H Dentalwerk Burmoos GmbH (HSA 600:41/01-320/18/01_52) | HSA 6004101-320-18-01_52 FSN [PDF, 91 KB] (opens in new tab) |
02 Jan 2018 | Menicon O2 CARE, Menicon Co., Ltd (HSA 600:41/01-319/18/01_46) | HSA 6004101-319-18-01_46 FSN_Redacted [PDF, 2193 KB] (opens in new tab) |