Field Safety Notices
Field Safety Notice - Jan 2018
31 January 2018
Audiences
Healthcare professional
Industry member
Product-type
Medical devices
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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) |