Field Safety Notices
Field Safety Notice - Apr 2019
30 April 2019
Audiences
Healthcare professional
Industry member
Product-type
Medical devices
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Table caption
Date of Notification | Title | FSN |
|---|---|---|
30 Apr 2019 | Oxford Unicompartmental Knee Drill Guides (Phase 3/Domed Lateral), Biomet UK Ltd (HSA 600:41/01-008/19/02_79) | HSA 6004101-008-19-02_79 FSN_Redacted [PDF, 302 KB] (opens in new tab) |
29 Apr 2019 | MitraClip® XTR Clip Delivery System, Abbott Vascular (HSA 600:41/01-005/19/15_18) | HSA 6004101-005-19-15_18 FSN_Redacted [PDF, 199 KB] (opens in new tab) |
29 Apr 2019 | SOLOPATH® Re-collapsible Balloon Access System, and SOLOPATH® Balloon Expandable TransFemoral System, Terumo Medical Corporation (HSA 600:41/01-028/19/02_51) | HSA 6004101-028-19-02_51 FSN_Redacted [PDF, 2367 KB] (opens in new tab) |
29 Apr 2019 | MAHURKAR and Argyle acute hemodialysis catheters, Covidien llc (HSA 600:41/01-046/19/04_46) | HSA 6004101-046-19-04_46 FSN_Redacted [PDF, 3267 KB] (opens in new tab) |
29 Apr 2019 | Alinity hq Analyzer, Abbott GmbH & Co. KG (HSA 600:41/01-005/19/14_31) | HSA 6004101-005-19-14_31 FSN [PDF, 249 KB] (opens in new tab) |
29 Apr 2019 | Philips PageWriter TC30 Cardiograph, Philips Medical Systems (HSA 600:41/01-026/19/13_68) | HSA 6004101-026-19-13_68 FSN_Redacted [PDF, 1543 KB] (opens in new tab) |
26 Apr 2019 | Defibrillation Electrode SCHILLER, Schiller AG (HSA 600:41/01-056/19/02_18) | HSA 6004101-056-19-02_18 FSN [PDF, 224 KB] (opens in new tab) |
25 Apr 2019 | Philips SureSigns VS3/VS4 Monitors, Philips Medical Systems (HSA 600:41/01-026/19/12_43) | HSA 6004101-026-19-12_43 FSN_Redacted [PDF, 743 KB] (opens in new tab) |
25 Apr 2019 | Rotablator Rotational Atherectomy System and Labsystem PRO, Boston Scientific Corporation (HSA 600:41/01-007/19/04_46) | HSA 6004101-007-19-04_46 FSN_Redacted [PDF, 101 KB] (opens in new tab) |
25 Apr 2019 | Getinge 86/88 Series Washer Disinfector, Getinge Disinfection AB (HSA 600:41/01-224/19/03_64) | HSA 6004101-224-19-03_64 FSN_Redacted [PDF, 190 KB] (opens in new tab) |
22 Apr 2019 | ABBOTT ALINITY C PROCESSING MODULE, CUVETTE SEGMENT, Abbott GmbH&Co KG (HSA 600:41/01-005/19/13_57) | HSA 6004101-005-19-13_57 FSN [PDF, 466 KB] (opens in new tab) |
22 Apr 2019 | Brizio Membrane Oxygenator and Venous Reservoir, Nipro Medical Ltda (HSA 600:41/01-233/19/01_52) | HSA 6004101-233-19-01_52 FSN_Redacted [PDF, 6241 KB] (opens in new tab) |
18 Apr 2019 | Samsung GM85 Digital Mobile X-Ray Imaging Systems, Samsung Electronics Co., Ltd. (HSA 600:41/01-087/19/02_76) | HSA 6004101-087-19-02_76 FSN_Redacted [PDF, 114 KB] (opens in new tab) |
18 Apr 2019 | Evis Lucera Duodenovideoscope, Evis Exera Duodenovideoscope, Olympus Medical Systems Corp. (HSA 600:41/01-004/19/02_44) | HSA 6004101-004-19-02_44 FSN_Redacted [PDF, 1257 KB] (opens in new tab) |
17 Apr 2019 | Schiller Medical DEFIGARD Touch 7, Schiller Medical (HSA 600:41/01-340/19/02_71) | HSA 6004101-340-19-02_71 FSN_Redacted [PDF, 125 KB] (opens in new tab) |
16 Apr 2019 | DERMABONDTM PRINEOTM SKIN CLOSURE SYSTEM, Ethicon LLC (HSA 600:41/01-002/19/08_44) | HSA 6004101-002-19-08_44 FSN_Redacted [PDF, 284 KB] (opens in new tab) |
16 Apr 2019 | Mentor MemoryGel Siltex Silicone Gel filled breast implant, Mentor Medical Systems B.V. (HSA 600:41/01-002/19/07_76) | HSA 6004101-002-19-07_76 FSN_Redacted [PDF, 203 KB] (opens in new tab) |
15 Apr 2019 | CARDIOHELP EMERGENCY DRIVE, Maquet Cardiopulmonary GmbH (HSA 600:41/01-224/19/02_77) | HSA 6004101-224-19-02_77 FSN_Redacted [PDF, 244 KB] (opens in new tab) |
15 Apr 2019 | Artisan™ 70cm 2x8 Surgical Lead Kit, 35cm and 55cm 8 Contact Extension Kits, Linear™ 3-4 50cm and 70cm 8 Contact Lead Kit, Precision™ M8 Adapter, 15cm, Boston Scientific Corporation (HSA 600:41/01-007/19/03_51) | HSA 6004101-007-19-03_51 FSN_Redacted [PDF, 139 KB] (opens in new tab) |
15 Apr 2019 | Alinity i Processing Module, Abbott GmbH & Co. KG (HSA 600:41/01‐005/19/12_23) | HSA 6004101-005-19-12_23 FSN [PDF, 277 KB] (opens in new tab) |
11 Apr 2019 | VITROS Chemistry Products CK Slides on VITROS 250 or VITROS 350 Chemistry Systems, Ortho-Clinical Diagnostics (HSA 60041/01-303/19/04_61) | HSA 6004101-303-19-04_61 FSN [PDF, 215 KB] (opens in new tab) |
11 Apr 2019 | Dornier Standard Diode and Nd:YAG Lightguides, Dornier MedTech GmbH (HSA 600:41/01-161/19/01_38) | HSA 6004101-161-19-01_38 FSN_Redacted [PDF, 2415 KB] (opens in new tab) |
11 Apr 2019 | NAVIO INSTRUMENT KIT UK/BE/FR/DE/IT, Smith & Nephew, Inc. (HSA 600:41/01-073/19/07_35) | HSA 6004101-073-19-07_35 FSN [PDF, 75 KB] (opens in new tab) |
10 Apr 2019 | AurigaTM 30 and AurigaTM XL 4007 Laser System, Boston Scientific Corporation (HSA 600:41/01-007/19/02_66) | HSA 6004101-007-19-02_66 FSN_Redacted [PDF, 238 KB] (opens in new tab) |
09 Apr 2019 | Artis Zee and Arties Q/Q.zen Systems, Siemens Healthcare GmbH (HSA 600:41/01-022/19/09_54) | HSA 6004101-022-19-09_54 FSN_Redacted [PDF, 420 KB] (opens in new tab) |
09 Apr 2019 | Algisite M Surgical Dressing, Smith & Nephew Medical Ltd (HSA 600:41/01-073/19/06_37) | HSA 6004101-073-19-06_37 FSN [PDF, 132 KB] (opens in new tab) |
09 Apr 2019 | Philips IntelliVue MX40, Philips Medical Systems (HSA 600:41/01-026/19/11_48) | HSA 6004101-026-19-11_48 FSN (2)_Redacted [PDF, 341 KB] (opens in new tab) This FSN is an update to the original FSN published in Apr 2019. |
09 Apr 2019 | Philips IntelliVue MX40, Philips Medical Systems (HSA 600:41/01-026/19/11_48) | HSA 6004101-026-19-11_48 FSN_Redacted [PDF, 1490 KB] (opens in new tab) |
08 Apr 2019 | ARCHITECH HbA1c Calibrators, ARCHITECT Intact PTH Calibrators, ARCHITECT Intact PTH Controls, Multichem S Plus (assayed) Level 1, Multichem S Plus (assayed) Level 2, ARCHITECT STAT High Sensitive Troponin-I Calibrators, ARCHITECT STAT High Sensitive Troponin-I Control, Alinity i Anti-TPO Calibrators, ARCHITECT Sirolimus Calibrators, ABBOTT GmbH & Co. KG, Abbott Ireland Diagnostics Division, Abbott Laboratories Diagnostics Division, Technopath Manufacturing Ltd (HSA 600:41/01-005/19/11_69) | HSA 6004101-005-19-11_69 FSN [PDF, 295 KB] (opens in new tab) |
05 Apr 2019 | Lyphochek Specialty Immunoassay Control, Bio-Rad Laboratories Inc (HSA 600:41/01-027/19/01_59) | HSA 6004101-027-19-01_59 FSN [PDF, 112 KB] (opens in new tab) |
05 Apr 2019 | T7 Cannulated Driver AO and T7 Driver Solid AO, Biomet Orthopedics (HSA 600:41/01-008/19/01_18) | HSA 6004101-008-19-01_18 FSN_Redacted [PDF, 250 KB] (opens in new tab) |
04 Apr 2019 | MobileDiagnost wDR, Philips Medical Systems (HSA 600:41/01-026/19/10_74) | HSA 6004101-026-19-10_74 FSN_Redacted [PDF, 142 KB] (opens in new tab) |
04 Apr 2019 | GE Healthcare Detector Mounting Screws for Nuclear Medicine Systems (Discovery NM 630, Discovery NM/CT 670 CZT, Discovery NM/CT 670 DR,Discovery NM/CT 670 ES, Optima NM/CT 640, NM 830, NM/CT 850, NM/CT 860, NM/CT 870 CZT, NM/CT 870 DR), GE Medical Systems Israel (HSA 600:41/01-010/19/09_38) | HSA 6004101-010-19-09_38 FSN_Redacted [PDF, 113 KB] (opens in new tab) |
04 Apr 2019 | MyLab Six and MyLab Gamma, Esaote SpA (HSA 600:41/01-263/19/01_48) | HSA 6004101-263-19-01_48 FSN_Redacted [PDF, 157 KB] (opens in new tab) |
04 Apr 2019 | FRED Easy defibrillator, Schiller Medical (HSA 600:41/01-340/19/01_46) | HSA 6004101-340-19-01_46 FSN_Redacted [PDF, 414 KB] (opens in new tab) |
03 Apr 2019 | enFlow Disposable Cartridge & enFlow Disposable Cartridge with IV Extension Set, Vyaire Medical Inc. (HSA 600:41/01-199/19/02_71) | HSA 6004101-199-19-02_71 FSN_Redacted [PDF, 367 KB] (opens in new tab) |
03 Apr 2019 | PROXIMATE ILS Curved and Straight Intraluminal Stapler and ENDOPATH ILS Endoscopic Curved Intraluminal Stapler, Ethicon Endo-Surgery, LLC (HSA 600:41/01-002/19/06_43) | HSA 6004101-002-19-06_43 FSN_Redacted [PDF, 328 KB] (opens in new tab) |
03 Apr 2019 | Philips Ingenia Ambition S and Philips Ingenia Ambition X, Philips Medical Systems Nederland B.V (HSA 600:41/01-026/19/09_56) | HSA 6004101-026-19-09_56 FSN_Redacted [PDF, 193 KB] (opens in new tab) |
03 Apr 2019 | HeartMate 3™ Left Ventricular Assist System (LVAS) kit, Thoratec Corporation (HSA 600:41/01-339/19/01_52) | HSA 6004101-339-19-01_52 FSN_Redacted [PDF, 160 KB] (opens in new tab) |
02 Apr 2019 | Drill Mini-Trephination 2.0mm, Medtronic Xomed (HSA 600:41/01-009/19/05_51) | HSA 6004101-009-19-05_51 FSN_Redacted [PDF, 130 KB] (opens in new tab) |
02 Apr 2019 | Bilirubin direct Gen 2, cobas c701/702, Roche Diagnostics GmbH (HSA 600:41/01-016/19/05_69) | HSA 6004101-016-19-05_69 FSN [PDF, 130 KB] (opens in new tab) |
02 Apr 2019 | The Infinity® Acute Care System and Standalone Infinity® M540 patient monitor, Draeger Medical Systems, Inc. (HSA 600:41/01-063/19/03_56) | HSA 6004101-063-19-03_56 FSN_Redacted [PDF, 850 KB] (opens in new tab) |
18 July 2018 | Philips SureSigns Patient Monitors, VS3 System,VS4 Vital Signs Monitor, and VSV Vital Signs Viewer, Philips Medical Systems (HSA 600:41/01-026/18/21_54) | HSA 6004101-026-18-21_54 FSN_Redacted [PDF, 157 KB] (opens in new tab) This FSN is an update to the original FSN published in Jul 2018. |