Field Safety Notices
Field Safety Notice - Feb 2018
Audiences
Healthcare professional
Industry member
Product type
Medical devices
28 February 2018
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Table caption
Date of Notification | Title | FSN |
|---|---|---|
27 Feb 2018 | HeartStart FRx, HeartStart Onsite, HeartStart Home AEDs, Philips Medical Systems (HSA 600:41/01-026/18/10_62) | |
27 Feb 2018 | Versatex™ Monofilament Mesh 50 x 50 cm, Sofradim Production (HSA 600:41/01-046/18/02_40) | |
27 Feb 2018 | REMEL™ R30166601 - NEISSERIA MENINGITIDIS POLY A-D 2ML/VL; REMEL™ R30167001 - NEISSERIA MENINGITIDIS GROUP D 2ML/VL, Remel Europe Ltd (HSA 600:41/01-178/18/01_57) | |
26 Feb 2018 | VITEK® 2 Compact 15; VITEK® 2 Compact 30 system; bioMerieux, Inc. (HSA 600:41/01-146/18/03_69) | |
26 Feb 2018 | Quick connect scale used with Maxi Sky 2 ceiling lifts, ArjoHuntleigh AB (HSA 600:41/01-065/18/01_56) | |
23 Feb 2018 | MeniCare SoR 70ML, Menicon Co., Ltd (HSA 600:41/01-319/18/02_46) | |
21 Feb 2018 | COBAS B 221 <2> SYSTEM, COBAS B 221 <4> SYSTEM, COBAS B 221 <6> SYSTEM, AUTOQC MODULE COMPLETE COBAS B 221, Roche Diagnostics GmbH (HSA 600:41/01-016/18/02_67) | |
21 Feb 2018 | Flow QC Tubing, Transonic Systems Inc. (HSA 600:41/01-070/18/04_43) | |
20 Feb 2018 | Oncor Impression Plus, Siemens Healthcare GmbH (HSA 600:41/01-022/18/06_46) | |
20 Feb 2018 | URF-P6/P6R, URF-V2/V2R URETERO-RENO ENDOSCOPES, Olympus Medical Systems Corp. (HSA 600:41/01-004/18/01_52) | |
14 Feb 2018 | Infinity Acute Care System (IACS), Infinity M540 patient monitor, Draeger Medical Systems, Inc. (HSA 600:41/01-063/18/01_63) | |
12 Feb 2018 | Alinity ci-series System Control Module (SCM), Abbott GmbH & Co. KG (HSA 600:41/01-005/18/01_31) | |
12 Feb 2018 | TEE probes: 6VT-D, 6Tc, 6Tc-RS, 9T, 9T-RS, 6T, 6T-RS, GE Vingmed Ultrasound AS (HSA 600:41/01-010/18/03_51) | |
12 Feb 2018 | Barrx™ 360 Express RFA Balloon Catheter, Covidien llc (HSA 600:41/01-046/18/01_44) | |
12 Feb 2018 | VeriQ Systems, VeriQ C Systems, MiraQ Systems, Medistim ASA (HSA 600:41/01-218/18/01_40) | |
12 Feb 2018 | Capio Suture Capturing Devices (SLIM, Standard, Open Access, RP), Uphold Vaginal Support System, Uphold LITE with Capio SLIM Vaginal Support System, Pinnacle Anterior Pelvic Floor Repair Kit, Pinnacle Posterior Pelvic Floor Repair Kit, Pinnacle LITE posterior with CAPIO SLIM Pelvic Floor Repair Kit, Boston Scientific Corporation (HSA 600:41/01-007/18/01_49) | |
12 Feb 2018 | VITROS Chemistry Products %A1c Performance Verifiers I&II, Ortho Clinical Diagnostics Inc (HSA 600:41/01-303/18/03_61) | |
09 Feb 2018 | Allura Xper with FlexVision large screen monitor, Philips Medical Systems Nederland BV (HSA 600:41/01-026/18/09_37) | |
09 Feb 2018 | Invivo DynaCAD Software, Invivo Corporation (HSA 600:41/01-026/18/08_45) | |
09 Feb 2018 | EXACTRAC VERSION 6.0 - 6.5, Brainlab AG (HSA 600:41/01-047/18/01_25) | |
09 Feb 2018 | 3M™ Surgical Clipper Professional 9681, 3M Health Care (HSA 600:41/01-031/18/01_35) | |
07 Feb 2018 | Somatom Emotion, Sensation, Spirit, Scope, Perspective, Siemens Healthcare GmbH (HSA 600:41/01-022/18/05_71) | |
07 Feb 2018 | Arctic Sun 5000 Temperature Management System, Bard Limited (HSA 600:41/01-050/18/01_66) | |
07 Feb 2018 | BIO-CAL Temperature Controller, Medtronic Inc (HSA 600:41/01-009/18/02_18) | |
06 Feb 2018 | Legion HK Distal Femoral Wedge SZ5 5mm, Smith & Nephew Inc. (HSA 600:41/01-073/18/02_56) | |
06 Feb 2018 | VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody, Roche Diagnostics GmbH (HSA 600:41/01-016/18/01_58) | |
06 Feb 2018 | ORBIT INCISOR PLUS EP-1 (6/BX), Smith & Nephew Inc (HSA 600:41/01-073/18/03_49) | |
06 Feb 2018 | Somatom Emotion, Spirit/Power, Scope/Power, Perspective, Siemens Shanghai Medical Equipment Ltd (HSA 600:41/01-022/18/04_68) | |
06 Feb 2018 | Dornier Gemini, Dornier MedTech GmbH (HSA 600:41/01-161/18/01_64) | |
05 Feb 2018 | Triathlon TS Augments, Howmedica Ostenics Corp (HSA 600:41/01-014/18/03_45) | |
02 Feb 2018 | Proteus 235 - Proton Therapy System, Ion Beam Applications S.A. (HSA 600:41/01-070/18/03_71) | |
02 Feb 2018 | Centricity Universal Viewer with PACS-IW foundation 6.0 and Centricity PACS-IW with Universal Viewer version 5.0, GE Healthcare (HSA 600:41/01-010/18/02_66) |