Summary of Field Safety Notices September 2024

01/10/2024
Medical devices Summary of field safety notices (FSN)

We have published a monthly summary of Field Safety Notices (FSN) affecting the Irish market for September 2024 below. 

The naming convention for each document is <product name><manufacturer name><the type of action taken by the manufacturer>.

Documents

NuVisc Pro_CROMA-PHARMA GmbH_Advice regarding changesupdates made to instructions for use PDF : 2.45MB | 12/02/2025 Leica Biosystems Cryostats_Leica Biosystems Nussloch GmbH_Advice regarding changesupdates made to instructions for use PDF : 1MB | 12/02/2025 Maquet Cardiosave Hybrid and Maquet Cardiosave Rescue_Datascope Corp._Advice regarding a software upgrade PDF : 819KB | 12/02/2025 Spaceplus Perfusor® (with TOM functionality)_B.Braun Melsungen AG_Advice regarding a software upgrade PDF : 671KB | 12/02/2025 Allura Xper, Azurion, Integris, MultiDiagnost Eleva_Philips Medical Systems Nederland BV_Advice regarding a device modification PDF : 617KB | 12/02/2025 MEGA Intra-aortic balloon catheter_Datascope Corporation_Advice regarding a device removal PDF : 652KB | 12/02/2025 All BiPAP A30, BiPAP A30 EFL, BiPAP A30 Hybrid, BiPAP A40, BiPAP A40 EFL, BiPAP A40 Pro devices_Respironics, Inc._Advice regarding changesupdates made to instructions for use PDF : 593KB | 12/02/2025 BodyGuard MultiPurpose Infusion Pump System_Caesarea Medical Electronics Limited_Advice regarding the use of the device PDF : 294KB | 12/02/2025 Ly-on_Jenx Ltd_Advice regarding the use of the device PDF : 343KB | 12/02/2025 Bronchovideoscope (BFH1100), Bronchovideoscope (BF-1TH1100), EVIS EXERA III Gastrointestinal Videoscope (GIF-H190N), EVIS EXERA III Small Intestinal Videoscope (SIF-H190), Gastro PDF : 344KB | 12/02/2025 CADD-Solis AC Adapter Model 21-0270-25_Smiths Medical _Advice regarding the use of the device PDF : 339KB | 12/02/2025 Halyard IR1080 and IR1087 CPT_ArcRoyal uc, an Owens & Minor Company_Advice regarding a device removal PDF : 410KB | 12/02/2025 Trilogy Evo, Trilogy Evo O2, Trilogy EV300_Philips Respironics, Inc._Advice regarding the use of the device PDF : 378KB | 12/02/2025 CADD Medication Cassette Reservoir_Smiths Medical. ASD Inc. (currently ICU Medical Inc.)_Advice regarding a device removal PDF : 390KB | 12/02/2025 Chameleon™ Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter_Covidien llc_Advice regarding a device removal PDF : 381KB | 12/02/2025 Wireless Recharger Kits, Models RS6230 and RS7230_Medtronic Inc._Advice regarding a device removal PDF : 240KB | 12/02/2025 Yankauer Suction Tube_Blink Medical_Advice regarding a device removal PDF : 228KB | 12/02/2025 Viewpoint_GE Healthcare GmbH_Advice regarding a software upgrade PDF : 175KB | 12/02/2025 Blue Diamond, basixTOUCH, DiamondTOUCH, IntelliSystem, BlueFIRE, MONARCH, Custom Inflation Kit, basixSKY, and StabilitiTOUCH inflation devices_Merit Medical Systems, Inc. USA_Adv PDF : 189KB | 12/02/2025 Access TSH (3rd IS) 2x200 DET Reagent Packs_lmmunotech S.A.S. - A Beckman Coulter Company_Advice regarding a device removal PDF : 161KB | 12/02/2025 Battery corpuls cpr (LiPo) REF 09120_GS Elektromedizinische Geräte G. Stemple GmbH_Advice regarding a device modification PDF : 164KB | 12/02/2025 Centricity Universal Viewer Zero Footprint client_GE Healthcare_Advice regarding a software upgrade PDF : 200KB | 12/02/2025 Giraffe Warmer, Panda iRes Warmer_Datex-Ohmeda, Inc. _Advice regarding the use of the device PDF : 202KB | 12/02/2025 bk3500, bk3000, bk5000 & bkActiv 2300 Ultrasound Devices with battery option _BK Medical Aps_Advice regarding the use of the device PDF : 113KB | 12/02/2025 OFP 2 Flushing Pump_Olympus KeyMed_Advice regarding the use of the device PDF : 135KB | 12/02/2025 ACUSON Redwood_Siemens Medical Solutions USA, Inc. Ultrasound_Advice regarding a software upgrade PDF : 134KB | 12/02/2025 AVVIGO Multi-Modality Guidance System_Boston Scientific Corporation_Advice regarding the use of the device PDF : 156KB | 12/02/2025 Randox HbA1c Calibrator Set_Randox Laboratories Ltd._Advice regarding changesupdates made to instructions for use PDF : 162KB | 12/02/2025 Coombs Anti-IgG, ID-DiaCell I-II-III, LISSCoombs_BioRadDiaMed GmbH_Advice regarding the use of the device PDF : 205KB | 12/02/2025 GMK Sphere Tibial Insert Flex_Medacta International_Advice regarding a device removal PDF : 91KB | 12/02/2025 CADD-Solis Ambulatory Infusion Pump Rechargeable Battery Pack_Smiths Medical _Advice regarding the use of the device PDF : 186KB | 12/02/2025 Centricity PACS System_GE Healthcare_Advice regarding the use of the device PDF : 90KB | 12/02/2025