Field Safety Notices
Field Safety Notice - Nov 2018
30 November 2018
Audiences
Healthcare professional
Industry member
Product-type
Medical devices
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Table caption
Date of Notification | Title | FSN |
|---|---|---|
30 Nov 2018 | MULTICHEM IA PLUS, Technopath Manufacturing Ltd. (HSA 600:41/01-005/18/25_67) | HSA 6004101-005-18-25_67 FSN_Redacted [PDF, 663 KB] (opens in new tab) |
30 Nov 2018 | Centricity Universal Viewer Zero Footprint Client, GE Healthcare (HSA 600:41/01-010/18/27_71) | HSA 6004101-010-18-27_ 71 FSN_Redacted [PDF, 318 KB] (opens in new tab) |
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) | HSA 6004101-126-18-05_79 FSN_Redacted [PDF, 3956 KB] (opens in new tab) |
29 Nov 2018 | Maestro Cochlear Implant system, MED-EL Elektromedizinische Geraete GmbH (HSA 600:41/01-247/18/01_64) | HSA 6004101-247-18-01_64 FSN_Redacted [PDF, 52 KB] (opens in new tab) |
26 Nov 2018 | CWP 800 (Central Water Plant) systems and Clinic Panels, Gambro Lundia AB (HSA 600:41/01-001/18/05_37) | HSA 6004101-001-18-05_37 FSN_Redacted [PDF, 107 KB] (opens in new tab) |
26 Nov 2018 | Nanoknife Disposable Single Electrode Probes, AngioDynamics, Inc (HSA 600:41/01-330/18/01_37) | HSA 6004101-330-18-01_37 FSN_Redacted [PDF, 207 KB] (opens in new tab) |
22 Nov 2018 | Alinity i Reagent Kits, Abbott Ireland Diagnostics Division (HSA 600:41/01-005/18/24_67) | HSA 6004101-005-18-24_67 FSN_Redacted [PDF, 422 KB] (opens in new tab) |
22 Nov 2018 | Lock Screw Square Drive, Biomet Orthopedics (HSA 600:41/01-008/18/19_52) | HSA 6004101-008-18-19_52 FSN_Redacted [PDF, 240 KB] (opens in new tab) |
21 Nov 2018 | Visions PV .035 Intravascular Ultrasound (IVUS) Catheter, Volcano Corporation (HSA 600:41/01-070/18/23_54) | HSA 6004101-070-18-23_54 FSN_Redacted [PDF, 832 KB] (opens in new tab) |
21 Nov 2018 | Pneumoclear Heated High-Flow Tube Set, Stryker Endoscopy (HSA 600:41/01-014/18/09_62) | HSA 6004101-014-18-09_62 FSN_Redacted [PDF, 247 KB] (opens in new tab) |
21 Nov 2018 | Efficia 3/5 ECG Trunk Cable, Philips Goldway (Shenzhen) Industrial Inc., (HSA 600:41/01-026/18/32_62) | HSA 6004101-026-18-32_62 FSN_Redacted [PDF, 159 KB] (opens in new tab) |
20 Nov 2018 | Philips HeartStart MRx Defibrillator/Monitor, Philips Medical Systems (HSA 600:41/01-026/18/31_48) | HSA 6004101-026-18-31_48 FSN_Redacted [PDF, 951 KB] (opens in new tab) |
19 Nov 2018 | Covidien Emprint™ Ablation System, Covidien llc (HSA 600:41/01-046/18/12_64) | HSA 6004101-046-18-12_64 FSN_Redacted [PDF, 887 KB] (opens in new tab) |
19 Nov 2018 | Geenen Sof-Flex Pancreatic Stents, Wilson-Cook Medical, Inc (HSA 600:41/01-013/18/08_48) | HSA 6004101-013-18-08_48 FSN_Redacted [PDF, 1291 KB] (opens in new tab) |
16 Nov 2018 | ThermoScientific™ Oxoid™ Brilliance VRE Agar, Oxoid Limited (Thermo Fisher Scientific (HSA 600:41/01-178/18/07_69) | HSA 6004101-178-18-07_69 FSN_Redacted [PDF, 391 KB] (opens in new tab) |
15 Nov 2018 | STACLOT LA, Diagnostica Stago (HSA 600:41/01-137/18/03_34) | HSA 6004101-137-18-03_34 FSN_Redacted [PDF, 156 KB] (opens in new tab) |
15 Nov 2018 | Carescape R860, Datex-Ohmeda, Inc (HSA 600:41/01-010/18/26_46) | HSA 6004101-010-18-26_46 FSN_Redacted [PDF, 585 KB] (opens in new tab) |
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) | HSA 6004101-008-18-18_44 FSN_Redacted [PDF, 239 KB] (opens in new tab) |
14 Nov 2018 | Nellix® EndoVascular Aneurysm Sealing System, Endologix International Holdings B.V. (HSA 600:41/01-329/18/01_52) | HSA 6004101-329-18-01_52 FSN_Redacted [PDF, 1370 KB] (opens in new tab) |
10 Nov 2018 | Early CDT-Lung Test kit, Oncimmune Limited (HSA 600:41/01-328/18/01_61) | HSA 6004101-328-18-01_61 FSN_Redacted [PDF, 111 KB] (opens in new tab) |
8 Nov 2018 | HemoTrol High (Level 3), HemoCue AB (HSA 600:41/01-070/18/22_78) | HSA 6004101-070-18-22_78 FSN_Redacted [PDF, 369 KB] (opens in new tab) |
7 Nov 2018 | Maintenance Solution Kit, Phadia AB (HSA 600:41/01-033/18/05_73) | HSA 6004101-033-18-05_73 FSN_Redacted [PDF, 82 KB] (opens in new tab) |
7 Nov 2018 | Alere™ BinaxNOW® Legionella Urinary Antigen Card, Alere Scarborough, Inc. (HSA 600:41/01‐111/18/01_23) | HSA 6004101-111-18-01_23 FSN [PDF, 208 KB] (opens in new tab) |
5 Nov 2018 | DA VINCI SI® DRAPE AND DISPOSABLE ACCESSORY KITS, Intuitive Surgical Inc. (HSA 600:41/01-070/18/21_51) | HSA 6004101-070-18-21_51 FSN [PDF, 313 KB] (opens in new tab) |
2 Nov 2018 | NexGen Complete Knee Solution Femoral Augment Block Distal Only, Zimmer Inc. (HSA 600:41/01-008/18/17_76) | HSA 6004101-008-18-17_76 FSN_Redacted [PDF, 263 KB] (opens in new tab) |
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 | HSA 6004101-007-18-06_50 FSN_Redacted [PDF, 6426 KB] (opens in new tab) |
1Nov 2018 | LifeStream Balloon Expandable Vascular Covered Stent, ClearStream Technologies Ltd. (HSA 600:41/01-050/18/07_44) | HSA 6004101-050-18-07_44 FSN_Redacted [PDF, 283 KB] (opens in new tab) |
1Nov 2018 | Biosense Webster ThermoCool® SmartTouchTM Diagnostic/Ablation Deflectable Tip Catheter, Biosense Webster Inc. (HSA 600:41/01-002/18/08_51) | HSA 6004101-002-18-08_51 FSN_Redacted [PDF, 287 KB] (opens in new tab) |
1Nov 2018 | Delfia Xpress Sample Tube Rack, Wallac Oy 9 HSA 600:41/01-127/18/01_49) | HSA 6004101-127-18-01_49 FSN_Redacted [PDF, 2319 KB] (opens in new tab) |
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] (opens in new tab) 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] (opens in new tab) This FSN is an update to the original FSN published in Nov 2017. |