Field Safety Notices
Field Safety Notice - Aug 2017
31 August 2017
Audiences
Healthcare professional
Industry member
Product-type
Medical devices
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Table caption
Date of Notification | Title | FSN |
|---|---|---|
31 Aug 2017 | BD Vacutainer® EDTA Blood Collection Tubes, Becton, Dickinson and Company (BD) (HSA 600:41/01-003/17/16_48) | HSA 6004101-003-17-16_48 FSN_Redacted [PDF, 781 KB] (opens in new tab) |
31 Aug 2017 | META-TAN 10MM X 38CM RIGHT, Smith & Nephew Inc (HSA 600:41/01-073/17/11_64) | HSA 6004101-073-17-11_64 FSN [PDF, 135 KB] (opens in new tab) |
31 Aug 2017 | META-TAN lOMM X 34CM LEFT, Smith & Nephew Inc (HSA 600:41/01-073/17/12_51) | HSA 600 41 01-073 17 12_51 FSN [PDF, 135 KB] (opens in new tab) |
30 Aug 2017 | 5X55MM KII OPTICAL Z-THREAD DUAL PACK, Applied Medical Resources Corporation (HSA 600:41/01-163/17/01_48) | HSA 6004101-163-17-01_48 FSN_Redacted [PDF, 117 KB] (opens in new tab) |
29 Aug 2017 | Merlin PCS 3650 Software Upgrade Kit, St. Jude Medical, Cardiac Rhythm Management Division (HSA 600:41/01-025/17/02_54) | HSA 6004101-025-17-02_54_FSN_Redacted [PDF, 103 KB] (opens in new tab) |
29 Aug 2017 | Merlin PCS 3650 Software Upgrade Kit, St. Jude Medical, Cardiac Rhythm Management Division (HSA 600:41/01-025/17/03_54) | HSA 6004101-025-17-03_54_FSN_Redacted [PDF, 159 KB] (opens in new tab) |
25 Aug 2017 | GENTIAN BECKMAN COULTER CYSTATIN C, Gentian AS (HSA 600:41/01-052/17/10_58) | HSA 6004101-052-17-10_58 FSN_Redacted [PDF, 3468 KB] (opens in new tab) |
24 Aug 2017 | Versys 6” Beaded Full Coat Plus Hip Prosthesis ; Zimmer Segmental System, Distal Femoral Prosthesis, Zimmer, Inc. (HSA 600:41/01-008/17/10_51) | HSA 6004101-008-17-10_51 FSN_Redacted [PDF, 151 KB] (opens in new tab) |
24 Aug 2017 | KALARE, HDR-08A, Toshiba Medical Systems Corporation (HSA 600:41/01-064/17/03_63) | HSA 6004101-064-17-03_63 FSN [PDF, 71 KB] (opens in new tab) |
24 Aug 2017 | Vanguard Open Box Posterior Stabilized Femoral Components, Zimmer, Inc. (HSA 600:41/01-008/17/11_62) | HSA 6004101-008-17-11_62 FSN_Redacted [PDF, 304 KB] (opens in new tab) |
24 Aug 2017 | Persona Tibial Plate Provisionals and Tibial Sizing Plates, Zimmer, Inc. (HSA 600:41/01-008/17/12_35) | HSA 6004101-008-17-12_35 FSN_Redacted [PDF, 270 KB] (opens in new tab) |
23 Aug 2017 | Servo Air, Maquet Critical Care AB (HSA 600:41/01-081/17/03_37) | HSA 6004101-081-17-03_37 FSN_Redacted [PDF, 104 KB] (opens in new tab) |
22 Aug 2017 | IMPAC Monaco RTP System, IMPAC, Inc (HSA 600:41/01-101/17/05_44) | HSA 6004101-101-17-05_44 FSN_Redacted [PDF, 669 KB] (opens in new tab) |
22 Aug 2017 | Impac Monaco RTP System, IMPAC, Inc (HSA 600:41/01-101/17/06_50) | HSA 6004101-101-17-06_50_FSN_Redacted [PDF, 245 KB] (opens in new tab) |
22 Aug 2017 | IMPAC Monaco RTP System, IMPAC, Inc (HSA 600:41/01-101/17/04_49) | HSA 6004101-10-117-04_49 FSN_Redacted [PDF, 687 KB] (opens in new tab) |
18 Aug 2017 | Remel Wellcolex Color Shigella, Remel Europe Ltd (HSA 600:41/01-178/17/04_38) | HSA 6004101-178-17-04_38 FSN_Redacted [PDF, 128 KB] (opens in new tab) |
18 Aug 2017 | CLINITEK® Atlas 10 Reagent Pak & CLINITEK® Atlas PRO 12 Reagent Pak, Siemens Healthcare Diagnostics, Inc. (HSA 600:41/01-022/17/24_34) | HSA 6004101-022-17-24_34 FSN [PDF, 14 KB] (opens in new tab) |
17 Aug 2017 | Artis one systems with DP Transceiver below revision 03, Siemens Shenzhen Magnetic Resonance Ltd (HSA 600:41/01-022/17/25_35) | HSA 6004101-022-17-25_35 FSN_Redacted [PDF, 2679 KB] (opens in new tab) |
16 Aug 2017 | Abbott Realtime HIV-1 Qualitative, Abbott Molecular Inc (HSA 600:41/01-005/17/13_38) | HSA 6004101-005-17-13_38 FSN_Redacted [PDF, 145 KB] (opens in new tab) |
16 Aug 2017 | Mako RIO Partial Knee Arthroplasty (PKA) and Total Hip Arthroplasty (THA) Software Applications, MAKO Surgical Corp. (HSA 600:41/01-070/17/15_37) | HSA 6004101-070-17-15_37 FSN_Redacted [PDF, 88 KB] (opens in new tab) |
16 Aug 2017 | Remel Streptex Rapid Latex Agglutination Test, Remel Europe Ltd (HSA 600:41/01-148/17/03_23) | HSA 6004101-148-17-03_23 FSN_Redacted [PDF, 166 KB] (opens in new tab) |
16 Aug 2017 | UniPerc Adjustable Flange Tracheostomy Tube 15mm Connector Soft Seal Cuff, Smiths Medical Czech Republic A.S. (HSA 600:41/01-017/17/02_52) | HSA 6004101-017-17-02_52 FSN_Redacted [PDF, 430 KB] (opens in new tab) |
15 Aug 2017 | Allura Xper R9 and Azurion R1.1, Philips Medical Systems Nederland B.V. (HSA 600:41/01-026/17/12_40) | HSA 6004101-026-17-12_40 FSN_Redacted [PDF, 367 KB] (opens in new tab) |
15 Aug 2017 | VITROS® Immunodiagnostic Products Signal Reagent, Ortho- Clinical Diagnostics (HSA 600:41/01-303/17/10_67) | HSA 6004101-303-17-10_67 FSN_Redacted [PDF, 1170 KB] (opens in new tab) |
14 Aug 2017 | Lysercell WDF (WDF-200A), Sysmex Corporation (HSA 600:41/01-032/17/03_67) | HSA 6004101-032-17-03_67 FSN_Redacted [PDF, 749 KB] (opens in new tab) |
11 Aug 2017 | Oncentra® Brachy, Nucletron B.V. (HSA 600:41/01-101/17/03_19) | HSA 6004101-101-17-03_19 FSN_Redacted [PDF, 216 KB] (opens in new tab) |
11 Aug 2017 | LOCKING COMPRESSION PLATE (LCP) DRILL SLEEVE, Synthes GmbH (HSA 600:41/01-002/17/09_25) | HSA 6004101-002-17-09_25 FSN_Redacted [PDF, 137 KB] (opens in new tab) |
11 Aug 2017 | Nasal Cannula, Adult, Ningbo Fuchun Co., Ltd (HSA 600:41/01-314/17/01_18) | HSA 6004101-314-17-01_18 FSN [PDF, 3420 KB] (opens in new tab) |
10 Aug 2017 | Cell Saver Elite Disposable processing kits, Haemonetics Corporation (HSA 600:41/01-070/17/14_49) | HSA 6004101-070-17-14_49 FSN_Redacted [PDF, 157 KB] (opens in new tab) |
10 Aug 2017 | Cobas 8000 core unit, Roche Diagnostics GmbH (HSA 600:41/01-016/17/16_65) | HSA 6004101-016-17-16_65 FSN [PDF, 348 KB] (opens in new tab) |
08 Aug 2017 | Mako RIO Internal cPCI Card Cage, Mako Surgical Corporation (HSA 600:41/01-070/17/13_54) | HSA 6004101-070-17-13_54 FSN_Redacted [PDF, 92 KB] (opens in new tab) |
08 Aug 2017 | Covidien Emprint™ Ablation System, Covidien llc (HSA 600:41/01-046/17/06_64) | HSA 6004101-046-17-06_64 FSN_Redacted [PDF, 2201 KB] (opens in new tab) |
07 Aug 2017 | Alinity hq Analyzer, Abbott GmbH & Co. KG (HSA 600:41/01-005/17/12_65) | HSA 6004101-005-17-12_65 FSN [PDF, 112 KB] (opens in new tab) |
03 Aug 2017 | DiaSys Creatinine PAP FS, DiaSys Diagnostic Systems GmbH (HSA 600:41/01-032/17/02_34) | HSA 6004101-032-17-02_34 FSN [PDF, 230 KB] (opens in new tab) |
02 Aug 2017 | VERSAJET II Hydrosurgery System Console, Smith & Nephew Inc (HSA 600:41/01-073/17/10_18) | HSA 6004101-073-17-10_18 FSN [PDF, 118 KB] (opens in new tab) |
01 Aug 2017 | Cosman Medical Nitinol RF (TCN) Reusable Electrodes, Cosman Medical Inc. (HSA 600:41/01-313/17/01_56) | HSA 60041-01-313-17-01_56 FSN [PDF, 498 KB] (opens in new tab) |
01 Aug 2017 | Cystoscopy bridges and working inserts, Olympus Winter & Ibe GmbH (HSA 600:41/01-004-17/05_62) | HSA 6004101-004-17-05_62 FSN_Redacted [PDF, 1524 KB] (opens in new tab) |
01 Aug 2017 | Sekisui Medical Mediace TPLA, Sekisui Medical Mediace RPR Gen 2, Sekisui Medical Co. Ltd (HSA 600:41/01-016/17/15_61) | HSA 6004101-016-17-15_61 FSN [PDF, 558 KB] (opens in new tab) |
05 Jul 2017 | Roche Diagnostics cobas e 602, cobas e 601 and E170 modules, Roche Diagnostics GmbH (HSA 600:41/01-016/17/12_58) | HSA 6004101-016-17-12_58v2 FSN [PDF, 3557 KB] (opens in new tab) |
12 Jan 2017 | Boston Scientific EMBLEM S-ICD Programmer, Boston Scientific Corporation (HSA 600:41/01-007/17/01_35) | HSA 6004101-007-17-01_35 FSN_Redacted [PDF, 2567 KB] (opens in new tab) |
27 Dec 2016 | Ortho-Clinical VITROS Chemistry Products Na+ Slides, Ortho-Clinical Diagnostic Inc (HSA 600:41/01-303/16/08_60) | HSA 6004101-303-16-08_60 FSN Part 2_Redacted [PDF, 359 KB] (opens in new tab) |
23 May 2016 | Gentamicin, Roche Diagnostics GmbH (HSA 600:41/01-016/16/08_59) | HSA 6004101-016-16-08_59 FSN [PDF, 216 KB] (opens in new tab) |
28 Mar 2016 | DiaMed Diaclon Anti-N, DiaMed GmbH (HSA 600:41/01-027/16/03_22) | HSA 6004101-027-16-03_22 FSN_Redacted [PDF, 2998 KB] (opens in new tab) |