Field Safety Notices
Field Safety Notice - Mar 2018
Audiences
Healthcare professional
Industry member
Product type
Medical devices
31 March 2018
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30 Mar 2018 | Segmental System Proximal Femoral Component 38mm Offset, Zimmer, Inc. (HSA 600:41/01-008/18/07_54) | HSA 6004101-008-18-07_54 FSN_Redacted [PDF, 95 KB] (opens in new tab) |
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29 Mar 2018 | Gentle Threads Interference Screw, Biomet Orthopaedics (HSA 600:41/01-008/18/06_56) | HSA 6004101-008-18-06_56 FSN_Redacted [PDF, 340 KB] (opens in new tab) |
29 Mar 2018 | AC2000 Spring Arm, Macquet SAS (HSA 600:41/01-081/18/03_43) | HSA 6004101-081-18-03_43 FSN [PDF, 125 KB] (opens in new tab) |
28 Mar 2018 | BD Vacutainer® Push Button Blood Collection Set/BD Vacutainer® Ultra Touch™ Push Button Blood Collection Set, Becton Dickinson and Company (HSA 600:41/01-003/18/02_45) | HSA 6004101-003-18-02_45 FSN_Redacted [PDF, 342 KB] (opens in new tab) |
27 Mar 2018 | ZNN and M/DN Trauma Guide Wires, Zimmer, Inc. (HSA 600:41/01-008/18/05_40) | HSA 6004101-008-18-05_40 FSN_Redacted [PDF, 85 KB] (opens in new tab) |
27 Mar 2018 | Philips MultiDiagnost Eleva X-Ray Radiography System, Philips Medical Systems Nederland B.V. (HSA 600:41/01-026/18/13_50) | HSA 6004101-026-18-13_50 FSN_Redacted [PDF, 496 KB] (opens in new tab) |
27 Mar 2018 | Fabius GS Premium, Tiro, Tiro D-M, MRI, plus, plus XL, Dragerwerk AG & CO KGaA (HSA 600:41/01-063/18/03_54) | HSA 6004101-063-18-03_54 FSN_Redacted [PDF, 1537 KB] (opens in new tab) |
27 Mar 2018 | CARESCAPE R860 ventilator, Datex-Ohmeda Inc. (HSA 600:41/01-010/18/05_51) | HSA 6004101-010-18-05_51 FSN_Redacted [PDF, 379 KB] (opens in new tab) |
26 Mar 2018 | Philips Achieva 1.5T, Philips Multiva 1.5T Magnetic Resonance Imaging System, Philips Ingenia 1.5T Magnetic Resonance Imaging System, Philips Medical Systems Nederland B.V. (HSA 600:41/01-026-18-12_71) | HSA 6004101-026-18-12_71 FSN_Redacted [PDF, 355 KB] (opens in new tab) |
26 Mar 2018 | CP3000 w/ CTS 230V & CP3000 w/o CTS 230V, Sekisui Medical Co. LTD (HSA 600:41/01-005/18/03_57) | HSA 6004101-005-18-03_57 FSN_Redacted [PDF, 1332 KB] (opens in new tab) |
22 Mar 2018 | FilmArray® Blood Culture Identification (BCID) Panel, BioFire Diagnostics, LLC (HSA 600:41/01-146/18/04_57) | HSA 6004101-146-18-04_57 FSN [PDF, 433 KB] (opens in new tab) |
21 Mar 2018 | Stryker® T4 and T5 Togas, Stryker Instruments (HSA 600:41/01-014/18/04_68) | HSA 6004101-014-18-04_68 FSN [PDF, 302 KB] (opens in new tab) |
20 Mar 2018 | Rotating IV pole, GE Healthcare (HSA 600:41/01-010/18/04_50) | HSA 6004101-010-18-04_50 FSN_Redacted [PDF, 355 KB] (opens in new tab) |
20 Mar 2018 | Rythmic Evolution Blue, Mini Rythmic Evolution lockable Blue, Micrel Medical Devices S.A. (HSA 600:41/01-012/18/01_18) | HSA 6004101-012-18-01_18 FSN_Redacted [PDF, 312 KB] (opens in new tab) |
20 Mar 2018 | iChemVELOCITY Automated Urine Chemistry System, Iris Diagnostics, a Division of Iris International, Inc. (HSA 600:41/01-052/18/02_69) | HSA 6004101-052-18-02_69 FSN_Redacted [PDF, 101 KB] (opens in new tab) |
19 Mar 2018 | Draeger Infinity Acute Care System (IACS) Monitoring Solution, Draeger Medical Systems, Inc. (HSA 600:41/01-063/18/02_36) | HSA 6004101-063-18-02_36 FSN_Redacted [PDF, 113 KB] (opens in new tab) |
16 Mar 2018 | iQ200 Series Urine Microscopy Analyzer, Iris Diagnostics (HSA 600:41/01-052/18/01_67) | HSA 6004101-052-18-01_67 FSN_Redacted [PDF, 134 KB] (opens in new tab) |
15 Mar 2018 | PERI-LOC VOL DIST RAD LCK PL STD HD 9H SH R 135MM, Smith & Nephew, Inc. (HSA 600:41/01-073/18/06_44) | HSA 6004101-073-18-06_44 FSN [PDF, 175 KB] (opens in new tab) |
15 Mar 2018 | HALYARD Closed Suction Kits with Flex Connector, Halyard Health, Inc (HSA 600:41/01-259/18/01_49) | HSA 6004101-259-18-01_49 FSN_Redacted [PDF, 6652 KB] (opens in new tab) |
15 Mar 2018 | PERI-LOC K-WIRE 1.6MM X 150MM LENGTH TROCAR POINT, Smith & Nephew, Inc. (HSA 600:41/01-073/18/05_51) | HSA 6004101-073-18-05_51 FSN [PDF, 174 KB] (opens in new tab) |
14 Mar 2018 | Artisan Link, Agilent Technologies Denmark (HSA 600:41/01-086/18/01_69) | HSA-6004101-086-18-01_69 FSN_Redacted [PDF, 144 KB] (opens in new tab) |
13 Mar 2018 | Gambro Ultrafilter U9000, Gambro Dialysatoren GmbH (HSA 600:41/01-001/18/01_35) | HSA 6004101-001-18-01_35 FSN [PDF, 147 KB] (opens in new tab) |
12 Mar 2018 | DxTerityTM Diagnostic Catheter, Medtronic Inc (HSA 600:41/01-009/18/04_64) | HSA 6004101-009-18-04_64 FSN [PDF, 705 KB] (opens in new tab) |
10 Mar 2018 | Ortho-Clinical Diagnostics Biovue® System ABO-Rh/Reverse Grouping Cassette and Ortho-Clinical BioVue® System Anti-IgG Cassette, Ortho-Clinical Diagnostic (HSA 600:41/01-303/18/04_60) | HSA 6004101-303-18-04_60 FSN_Redacted [PDF, 435 KB] (opens in new tab) |
09 Mar 2018 | ID-DiaCell I-II-III, DiaMed GmbH (HSA 600:41/01-027/18/02_67) | HSA 6004101-027-18-02_67 FSN_Redacted [PDF, 2426 KB] (opens in new tab) |
08 Mar 2018 | D-RAD Titanium 2.4mm x 10mm Locking Screw T7 Self-Tapping, Smith & Nephew Inc. (HSA 600:41/01-073/18/04_43) | HSA 6004101-073-18-04_43 FSN [PDF, 174 KB] (opens in new tab) |
08 Mar 2018 | Acuson SC2000, Siemens Medical Solutions USA, Inc. (HSA 600:41/01-022/18/07_18) | HSA 6004101-022-18-07_18 FSN [PDF, 191 KB] (opens in new tab) |
07 Mar 2018 | LifePak 1000 Defibrillator, Physio-Control Inc (HSA 600:41/01-056/18/01_37) | HSA 6004101-056-18-01_37 FSN_Redacted [PDF, 101 KB] (opens in new tab) |
07 Mar 2018 | Subset of Medtronic Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and Implantable Cardioverter Defibrillators (ICDs), Medtronic Inc (HSA 600:41/01-009/18/03_35) | HSA 6004101-009-18-03_35 FSN [PDF, 302 KB] (opens in new tab) |
06 Mar 2018 | Comprehensive Segmental Revision System, Biomet Orthopaedics (HSA 600:41/01-008/18/04_36) | HSA 6004101-008-18-04_36 FSN_Redacted [PDF, 152 KB] (opens in new tab) |
06 Mar 2018 | Roche Diagnostics cobas® 8000 modular analyzer series - cobas e 801 module, Roche Diagnostics GmbH (HSA 600:41/01-016/18/03_70) | HSA 6004101-016-18-03_70 FSN [PDF, 1595 KB] (opens in new tab) |
06 Mar 2018 | Agilia Volumat Infusion Lines, Fresenius Vial (HSA 600:41/01-020/18/01_66) | HSA 6004101-020-18-01_66 FSN_Redacted [PDF, 2016 KB] (opens in new tab) |
05 Mar 2018 | Alinity ci-series System Control Module (SCM), Abbott GmbH & Co. KG (HSA 600:41/01-005/18/02_34) | HSA 6004101-005-18-02_34 FSN [PDF, 111 KB] (opens in new tab) |
02 Mar 2018 | M/L Taper Femoral Stem, Zimmer Inc. (HSA 600:41/01-008/18/03_37) | HSA 6004101-008-18-03_37 FSN_Redacted [PDF, 64 KB] (opens in new tab) |
02 Mar 2018 | Hill-Rom Progressa Bed System, Hill-Rom, Inc. (HSA 600:41/01-182/18/02_71) | HSA 6004101-182-18-02_71 FSN_Redacted [PDF, 247 KB] (opens in new tab) |
01 Mar 2018 | Servo ventilators, Maquet Critical Care AB (HSA 600:41/01-081/18/02_52) | HSA 6004101-081-18-02_52 FSN_Redacted [PDF, 85 KB] (opens in new tab) |
01 Mar 2018 | Cook Vacuum Pump™/ Cook Aspiration Unit™, William A. Cook Australia Pty Ltd (HSA 600:41/01-013/18/01_68) | HSA 6004101-013-18-01_68 FSN_Redacted [PDF, 359 KB] (opens in new tab) |
01 Mar 2018 | Philips Ingenuity Flex, Ingenuity CT, Philips Brilliance Computed Tomography X-Ray System,Philips IQon Spectral CT System, Philips Medical Systems (HSA 600:41/01-026/18/11_64) | HSA 6004101-026-18-11_64 FSN_Redacted [PDF, 525 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, 114 KB] (opens in new tab) This updated FSN replaces the original FSN published in January 2018 |