Field Safety Notices
Field Safety Notice - Nov 2018
Audiences
Healthcare professional
Industry member
Product type
Medical devices
30 November 2018
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 Nov 2018 | MULTICHEM IA PLUS, Technopath Manufacturing Ltd. (HSA 600:41/01-005/18/25_67) | |
30 Nov 2018 | Centricity Universal Viewer Zero Footprint Client, GE Healthcare (HSA 600:41/01-010/18/27_71) | |
30 Nov 2018 | BOND Slide Labeler Zebra Printer Power Supply Unit (PSU) for use with BOND-III and BOND-MAX Instruments, Leica Biosystems Melbourne (HSA 600:41/01-126/18/05_79) | |
29 Nov 2018 | Maestro Cochlear Implant system, MED-EL Elektromedizinische Geraete GmbH (HSA 600:41/01-247/18/01_64) | |
26 Nov 2018 | CWP 800 (Central Water Plant) systems and Clinic Panels, Gambro Lundia AB (HSA 600:41/01-001/18/05_37) | |
26 Nov 2018 | Nanoknife Disposable Single Electrode Probes, AngioDynamics, Inc (HSA 600:41/01-330/18/01_37) | |
22 Nov 2018 | Alinity i Reagent Kits, Abbott Ireland Diagnostics Division (HSA 600:41/01-005/18/24_67) | |
22 Nov 2018 | Lock Screw Square Drive, Biomet Orthopedics (HSA 600:41/01-008/18/19_52) | |
21 Nov 2018 | Visions PV .035 Intravascular Ultrasound (IVUS) Catheter, Volcano Corporation (HSA 600:41/01-070/18/23_54) | |
21 Nov 2018 | Pneumoclear Heated High-Flow Tube Set, Stryker Endoscopy (HSA 600:41/01-014/18/09_62) | |
21 Nov 2018 | Efficia 3/5 ECG Trunk Cable, Philips Goldway (Shenzhen) Industrial Inc., (HSA 600:41/01-026/18/32_62) | |
20 Nov 2018 | Philips HeartStart MRx Defibrillator/Monitor, Philips Medical Systems (HSA 600:41/01-026/18/31_48) | |
19 Nov 2018 | Covidien Emprint™ Ablation System, Covidien llc (HSA 600:41/01-046/18/12_64) | |
19 Nov 2018 | Geenen Sof-Flex Pancreatic Stents, Wilson-Cook Medical, Inc (HSA 600:41/01-013/18/08_48) | |
16 Nov 2018 | ThermoScientific™ Oxoid™ Brilliance VRE Agar, Oxoid Limited (Thermo Fisher Scientific (HSA 600:41/01-178/18/07_69) | |
15 Nov 2018 | STACLOT LA, Diagnostica Stago (HSA 600:41/01-137/18/03_34) | |
15 Nov 2018 | Carescape R860, Datex-Ohmeda, Inc (HSA 600:41/01-010/18/26_46) | |
15 Nov 2018 | Lineum ® OCT Spine System, LINEUM 4.35MM X 28MM CC SCREW, Zimmer Biomet Spine, Inc (HSA 600:41/01-008/18/18_44) | |
14 Nov 2018 | Nellix® EndoVascular Aneurysm Sealing System, Endologix International Holdings B.V. (HSA 600:41/01-329/18/01_52) | |
10 Nov 2018 | Early CDT-Lung Test kit, Oncimmune Limited (HSA 600:41/01-328/18/01_61) | |
8 Nov 2018 | HemoTrol High (Level 3), HemoCue AB (HSA 600:41/01-070/18/22_78) | |
7 Nov 2018 | Maintenance Solution Kit, Phadia AB (HSA 600:41/01-033/18/05_73) | |
7 Nov 2018 | Alere™ BinaxNOW® Legionella Urinary Antigen Card, Alere Scarborough, Inc. (HSA 600:41/01‐111/18/01_23) | |
5 Nov 2018 | DA VINCI SI® DRAPE AND DISPOSABLE ACCESSORY KITS, Intuitive Surgical Inc. (HSA 600:41/01-070/18/21_51) | |
2 Nov 2018 | NexGen Complete Knee Solution Femoral Augment Block Distal Only, Zimmer Inc. (HSA 600:41/01-008/18/17_76) | |
1Nov 2018 | Boston Scientific SQ-RX® Pulse Generator, Boston Scientific Corporation (HSA 600:41/01-007/18/06_50)Local Contact: Boston Scientific Asia Pacific Pte Ltd | |
1Nov 2018 | LifeStream Balloon Expandable Vascular Covered Stent, ClearStream Technologies Ltd. (HSA 600:41/01-050/18/07_44) | |
1Nov 2018 | Biosense Webster ThermoCool® SmartTouchTM Diagnostic/Ablation Deflectable Tip Catheter, Biosense Webster Inc. (HSA 600:41/01-002/18/08_51) | |
1Nov 2018 | Delfia Xpress Sample Tube Rack, Wallac Oy 9 HSA 600:41/01-127/18/01_49) | |
20 Dec 2017 | Cardiac Resynchronization Therapy pacemakers (VALITUDE™, VISIONIST™) and defibrillators (CHARISMA™, MOMENTUM™, RESONATE™, VIGILANT™, AUTOGEN™, DYNAGEN™, INOGEN™, ORIGEN™), Boston Scientific Corporation (HSA 600:41/01-007/17/14_43) | HSA 6004101-007-17-14_43 FSN_Redacted [PDF, 581 KB] This FSN is an update to the original FSN published in Dec 2017. |
1 Nov 2017 | Fabius with Auxilliary Common Gas Outlet (ACGO), Dragerwerk AG & Co. KGaA (HSA 600:41/01-063/17/05_62) | HSA 6004101-063-17-05_62 FSN_Redacted [PDF, 1638 KB] This FSN is an update to the original FSN published in Nov 2017. |