Field Safety Notices
Field Safety Notice - Apr 2019
Audiences
Healthcare professional
Industry member
Product type
Medical devices
30 April 2019
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 Apr 2019 | Oxford Unicompartmental Knee Drill Guides (Phase 3/Domed Lateral), Biomet UK Ltd (HSA 600:41/01-008/19/02_79) | |
29 Apr 2019 | MitraClip® XTR Clip Delivery System, Abbott Vascular (HSA 600:41/01-005/19/15_18) | |
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) | |
29 Apr 2019 | MAHURKAR and Argyle acute hemodialysis catheters, Covidien llc (HSA 600:41/01-046/19/04_46) | |
29 Apr 2019 | Alinity hq Analyzer, Abbott GmbH & Co. KG (HSA 600:41/01-005/19/14_31) | |
29 Apr 2019 | Philips PageWriter TC30 Cardiograph, Philips Medical Systems (HSA 600:41/01-026/19/13_68) | |
26 Apr 2019 | Defibrillation Electrode SCHILLER, Schiller AG (HSA 600:41/01-056/19/02_18) | |
25 Apr 2019 | Philips SureSigns VS3/VS4 Monitors, Philips Medical Systems (HSA 600:41/01-026/19/12_43) | |
25 Apr 2019 | Rotablator Rotational Atherectomy System and Labsystem PRO, Boston Scientific Corporation (HSA 600:41/01-007/19/04_46) | |
25 Apr 2019 | Getinge 86/88 Series Washer Disinfector, Getinge Disinfection AB (HSA 600:41/01-224/19/03_64) | |
22 Apr 2019 | ABBOTT ALINITY C PROCESSING MODULE, CUVETTE SEGMENT, Abbott GmbH&Co KG (HSA 600:41/01-005/19/13_57) | |
22 Apr 2019 | Brizio Membrane Oxygenator and Venous Reservoir, Nipro Medical Ltda (HSA 600:41/01-233/19/01_52) | |
18 Apr 2019 | Samsung GM85 Digital Mobile X-Ray Imaging Systems, Samsung Electronics Co., Ltd. (HSA 600:41/01-087/19/02_76) | |
18 Apr 2019 | Evis Lucera Duodenovideoscope, Evis Exera Duodenovideoscope, Olympus Medical Systems Corp. (HSA 600:41/01-004/19/02_44) | |
17 Apr 2019 | Schiller Medical DEFIGARD Touch 7, Schiller Medical (HSA 600:41/01-340/19/02_71) | |
16 Apr 2019 | DERMABONDTM PRINEOTM SKIN CLOSURE SYSTEM, Ethicon LLC (HSA 600:41/01-002/19/08_44) | |
16 Apr 2019 | Mentor MemoryGel Siltex Silicone Gel filled breast implant, Mentor Medical Systems B.V. (HSA 600:41/01-002/19/07_76) | |
15 Apr 2019 | CARDIOHELP EMERGENCY DRIVE, Maquet Cardiopulmonary GmbH (HSA 600:41/01-224/19/02_77) | |
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) | |
15 Apr 2019 | Alinity i Processing Module, Abbott GmbH & Co. KG (HSA 600:41/01‐005/19/12_23) | |
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) | |
11 Apr 2019 | Dornier Standard Diode and Nd:YAG Lightguides, Dornier MedTech GmbH (HSA 600:41/01-161/19/01_38) | |
11 Apr 2019 | NAVIO INSTRUMENT KIT UK/BE/FR/DE/IT, Smith & Nephew, Inc. (HSA 600:41/01-073/19/07_35) | |
10 Apr 2019 | AurigaTM 30 and AurigaTM XL 4007 Laser System, Boston Scientific Corporation (HSA 600:41/01-007/19/02_66) | |
09 Apr 2019 | Artis Zee and Arties Q/Q.zen Systems, Siemens Healthcare GmbH (HSA 600:41/01-022/19/09_54) | |
09 Apr 2019 | Algisite M Surgical Dressing, Smith & Nephew Medical Ltd (HSA 600:41/01-073/19/06_37) | |
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] 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) | |
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) | |
05 Apr 2019 | Lyphochek Specialty Immunoassay Control, Bio-Rad Laboratories Inc (HSA 600:41/01-027/19/01_59) | |
05 Apr 2019 | T7 Cannulated Driver AO and T7 Driver Solid AO, Biomet Orthopedics (HSA 600:41/01-008/19/01_18) | |
04 Apr 2019 | MobileDiagnost wDR, Philips Medical Systems (HSA 600:41/01-026/19/10_74) | |
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) | |
04 Apr 2019 | MyLab Six and MyLab Gamma, Esaote SpA (HSA 600:41/01-263/19/01_48) | |
04 Apr 2019 | FRED Easy defibrillator, Schiller Medical (HSA 600:41/01-340/19/01_46) | |
03 Apr 2019 | enFlow Disposable Cartridge & enFlow Disposable Cartridge with IV Extension Set, Vyaire Medical Inc. (HSA 600:41/01-199/19/02_71) | |
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) | |
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) | |
03 Apr 2019 | HeartMate 3™ Left Ventricular Assist System (LVAS) kit, Thoratec Corporation (HSA 600:41/01-339/19/01_52) | |
02 Apr 2019 | Drill Mini-Trephination 2.0mm, Medtronic Xomed (HSA 600:41/01-009/19/05_51) | |
02 Apr 2019 | Bilirubin direct Gen 2, cobas c701/702, Roche Diagnostics GmbH (HSA 600:41/01-016/19/05_69) | |
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) | |
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] This FSN is an update to the original FSN published in Jul 2018. |