Summary of Field Safety Notices November 2024

03/12/2024
Medical devices Summary of field safety notices (FSN)

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

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

Documents

One Step Pregnancy HCG Test_Atlastlink Technology_ Advice regarding a device removal PDF : 2.4MB | 07/02/2025 Viscosurgical device_Hyaltech_ Advice regarding the use of the device PDF : 1.16MB | 07/02/2025 ACURATE neo2TM and ACURATE PrimeTM Aortic Valve Systems_Boston Scientific_ Advice regarding changesupdates made to instructions for use PDF : 199KB | 07/02/2025 AK 98 hemodialysis machines_Baxter_ Advice regarding the use of the device PDF : 498KB | 07/02/2025 Access Substrate_BeckmanCoulter_Advice regarding a device removal PDF : 229KB | 07/02/2025 WEINMANN MEDUMAT Transport and MEDUMAT Standard² ventilators_Weinmann_ Advice regarding changesupdates made to instructions for use PDF : 211KB | 07/02/2025 Access hsTnI Reagent Kit_Beckman Coulter_ Advice regarding the use of the device PDF : 189KB | 07/02/2025 Proteus XRa systems_GE Healthcare_Advice regarding the use of the device PDF : 266KB | 07/02/2025 Sterilizable Internal Defibrillation Paddles_ Advice regarding the use of the device PDF : 327KB | 07/02/2025 Accu-Chek Spirit 3.15 ml cartridge system_Roche_ Advice regarding a device removal_HCP letter PDF : 114KB | 07/02/2025 TCM5 monitors_Radiometer_ Advice regarding a software upgrade PDF : 251KB | 07/02/2025 Thoraflex Hybrid_Terumo_ Advice regarding the use of the device PDF : 716KB | 07/02/2025 Tracheal Tube Reusable Introducer and Guides_Smiths Medical_ Advice regarding a device removal PDF : 310KB | 07/02/2025 Accu-Chek Spirit 3.15 ml cartridge system_Roche_ Advice regarding a device removal_Patient with Diabetes letter PDF : 114KB | 07/02/2025 Accu-Chek Spirit 3.15 ml cartridge system_Roche_ Advice regarding a device removal_Distributor letter PDF : 114KB | 07/02/2025 Philips MR system breast coils_Philips_ Advice regarding the use of the device PDF : 354KB | 07/02/2025 PD-L1 IHC 28-8 pharmDx PD-L1 28-8 pharmDx Kit (IUO)_Agilent Technologies_ Advice regarding the use of the device PDF : 254KB | 07/02/2025 Plum 360™, Plum A ™ & Plum A 3™ Infusion Systems_ICU Medical_ Advice regarding the use of the device PDF : 317KB | 07/02/2025 ROTEM sigma complete_Werfen_ Advice regarding the use of the device PDF : 405KB | 07/02/2025 AR-9800 Synergy RF Console_Arthrex GmbH_ Advice regarding a device modification PDF : 799KB | 07/02/2025 Vivo 45 LS (non-US) and Nippy 4 _Breas_ Advice regarding a software upgrade PDF : 127KB | 07/02/2025 DDP-100, 200P, 2001, 2002 Pediatric and Adult Defibrillation Pads_Defibtech_ Advice regarding a device removal PDF : 369KB | 07/02/2025 NxTAG® Respiratory Pathogen Panel_Diasorin_ Advice regarding a device removal PDF : 327KB | 07/02/2025 Percept™ RC Implantable Neurostimulator_Medtronic Limited _ Advice regarding a device removal_FSN 1 PDF : 173KB | 07/02/2025 MiniCap Extended Life PD transfer_Baxter_ Advice regarding the use of the device PDF : 251KB | 07/02/2025 BritePro Solo Single-Use Fiber Optic Laryngoscope_Flexicare_ Advice regarding the use of the device PDF : 523KB | 07/02/2025 ProBP 3400 Digital Blood Pressure Device_Baxter_Advice regarding a device removal PDF : 217KB | 07/02/2025 Q-FLOW SOLO, Q-FLOW DUO, Q-FLOW TRIO, Q-FLOW QUAD, Q-FLOW MOBILE_Merivaara_ Advice regarding a device modification PDF : 269KB | 07/02/2025 Percept™ RC Implantable Neurostimulator_Medtronic Limited _ Advice regarding a device removal_FSN2 PDF : 153KB | 07/02/2025 epoc® Blood Analysis System_Siemens_ Advice regarding a software upgrade PDF : 212KB | 07/02/2025 OMEGA Left Atrial Appendage (LAA) Occluder Device_Eclipse Medical_ Advice regarding a device removal PDF : 197KB | 07/02/2025 HScribe, Vision Express, Q-Stress, XScribe, and RScribe Software_Baxter_ Advice regarding a software upgrade PDF : 269KB | 07/02/2025 NIHON KOHDEN Recording Paper_Nihon Kohden_ Advice regarding the use of the device PDF : 152KB | 07/02/2025 DxI 9000 Access Immunoassay Analyzer_Beckman Coulter_ Advice regarding the use of the device PDF : 251KB | 07/02/2025 EZ Glide Aortic Cannulae_Edwards Lifesciences_ Advice regarding the use of the device PDF : 241KB | 07/02/2025 HOLDEX® Single-Use Holder PP single-packed_Greiner_ Advice regarding a device removal_FSN1 PDF : 66KB | 07/02/2025 HOLDEX® Single-Use Holder PP single-packed_Greiner_ Advice regarding a device removal_FSN3 PDF : 65KB | 07/02/2025 LIAISON® Q.S.E.T. Device Plus_Diasorin_ Advice regarding a device modification PDF : 124KB | 07/02/2025 Cybersecurity_BD_ Advice regarding a software upgrade PDF : 200KB | 07/02/2025 Corpuls AED_Corpuls_ Advice regarding a device removal PDF : 198KB | 07/02/2025 FACSLyric™ Flow Cytometers_BD_ Advice regarding a device modification PDF : 195KB | 07/02/2025 Cartiva Synthetic Cartilage Implant_Stryker_Advice regarding a device removal PDF : 344KB | 07/02/2025 HOLDEX® Single-Use Holder PP single-packed_Greiner_ Advice regarding a device removal_FSN2 PDF : 64KB | 07/02/2025 BD BBL Sensi Disc Ampicillin 2 μg (AM-2)_BD_ Advice regarding a device removal PDF : 301KB | 07/02/2025 EVIS LUCERA ELITE Videogastroscope_Olympus_ Advice regarding the use of the device PDF : 55KB | 07/02/2025 Allura Xper R7.6- R8.1 systems_Philips_ Advice regarding a device modification PDF : 426KB | 07/02/2025