Summary of Field Safety Notices June 2024

02/07/2024
Medical devices Summary of field safety notices (FSN)

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

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

Documents

Horizon DXA System_Hologic, Inc._Advice regarding the use of the device PDF : 820KB | 18/02/2025 Aqualine, Aqualine S, Aqualine RCA, Aqualine D_Haemotronic S.p.A_Advice regarding the use of the device PDF : 1.17MB | 18/02/2025 Everest Bipolar Cutting Forceps_Gyrus ACMI, Inc. (Olympus Surgical Technologies America)_Advice regarding a device removal PDF : 256KB | 18/02/2025 Various SIGNADiscoveryOptimaBrivo MR systems_GE HealthcareGE Medical Systems_Advice regarding the use of the device PDF : 349KB | 18/02/2025 BioFire BCID2 Panel_bioMérieux UK Ltd_Advice regarding the use of the device PDF : 427KB | 18/02/2025 Exeter 2.5 I M Plug_Stryker Joint Replacement_Advice regarding a device removal PDF : 308KB | 18/02/2025 Vasoview Hemopro, Vasoview Hemopro 2 _Maquet Cardiovascular, LLCGetinge USA_Advice regarding the use of the device PDF : 688KB | 18/02/2025 IdyllaTM EGFR Mutation Test_Biocartis_Advice regarding changesupdates made to instructions for use PDF : 503KB | 18/02/2025 ESG-410 electrosurgical generator_Olympus Winter & Ibe GmbH_Advice regarding a device modification PDF : 93KB | 18/02/2025 Bivona® NeonatalPediatric and Adult Tracheostomy_Smith Medical_Advice regarding a device removal PDF : 217KB | 18/02/2025 Discovery Humeral Stems_LimaCorporate S.p.A._Advice regarding the use of the device PDF : 220KB | 18/02/2025 DxI 9000 Access Immunoassay Analyzer_Beckman Coulter_Advice regarding the use of the device PDF : 139KB | 18/02/2025 INGENIO™, VITALIO™, and ADVANTIO™ dual chamber (DR) extended life (EL) pacemakers and INLIVEN™, INTUA™, and INVIVE™ cardiac resynchronization therapy pacemakers (CRT-Ps)_Cardiac Pacem PDF : 196KB | 18/02/2025 CPT 1196 containing MONOCRYL™ Plus Sutures_ArcRoyal uc, an Owens & Minor Company_Advice regarding a device removal PDF : 890KB | 18/02/2025 SYNCHRO Guidewires_Stryker Neurovascular_Advice regarding the use of the device PDF : 277KB | 18/02/2025 Surgical Guidance Software - Real Intelligence CORI_Smith & Nephew Orthopaedics_Advice regarding the use of the device PDF : 309KB | 18/02/2025 BiPAP A40 Pro, BiPAP A40 EFL, BiPAP A30 EFL_Philips Respironics, Inc._Advice regarding the use of the device PDF : 392KB | 18/02/2025 BeneHeart D1 Automated External Defibrillator_Shenzhen Mindray Bio-Medical Electronics_Advice regarding the use of the device PDF : 287KB | 18/02/2025 BeneHeart C Series Automated External Defibrillator_Shenzhen Mindray Bio-Medical Electronics Co., Ltd. _Advice regarding a software upgrade PDF : 337KB | 18/02/2025 ABL800 Basic and ABL8XX FLEX analyzers_Radiometer Medical ApS_Advice regarding the use of the device PDF : 172KB | 18/02/2025 SLE6000 Infant ventilator_Inspiration Healthcare_Advice regarding a device modification PDF : 260KB | 18/02/2025 Proclaim™, Proclaim™ XR, and Proclaim™ Elite SCS System, Proclaim™ DRG Neurostimulation System_Abbott Neuromodulation_Advice regarding the use of the device PDF : 232KB | 18/02/2025 Afinion 2_Abbott Diagnostics Technologies AS_Advice regarding the use of the device PDF : 250KB | 18/02/2025 Panoscreen I and II_Immucor, Inc._Advice regarding the use of the device PDF : 288KB | 18/02/2025 Multiva 1.5T_Philips Healthcare (Suzhou) Co., Ltd_Advice regarding a device modification PDF : 337KB | 18/02/2025 AU IgM (Immunoglobulin M )_Beckman Coulter Ireland Inc_Advice regarding the use of the device PDF : 166KB | 18/02/2025 BD Sensi-Disc_Becton, Dickinson and Company_Advice regarding changesupdates made to instructions for use PDF : 285KB | 18/02/2025 2nd Generation CentriMag Primary Console_Abbott Medical_Advice regarding the use of the device PDF : 188KB | 18/02/2025 CPT® Hip System Femoral Stem 1214 Neck Taper_Zimmer Inc._Advice regarding changesupdates made to instructions for use PDF : 242KB | 18/02/2025 cobas® EGFR Mutation Test v2_Roche Diagnostics GmbH_Advice regarding a software upgrade PDF : 37KB | 18/02/2025 Panocell®-10_Immucor, Inc._Advice regarding the use of the device PDF : 288KB | 18/02/2025 SENSE XL Torso coil (1.5T and 3.0T)_Philips Healthcare_Advice regarding the use of the device PDF : 418KB | 18/02/2025 Papenzyme-plus_Lorne Laboratories Ltd._Advice regarding a device removal PDF : 365KB | 18/02/2025 Spectra Optia Apheresis System_Terumo BCT Inc_Advice regarding the use of the device_ Customer Letter PDF : 198KB | 18/02/2025 Ringlight Fiber_LSO Medical_Advice regarding the use of the device PDF : 276KB | 18/02/2025 Puritan Bennett 500 series ventilators_Medtronics_Advice regarding the use of the device PDF : 190KB | 18/02/2025 Leoni plus HFO _Löwenstein Medical SE & Co. KG_Advice regarding the use of the device PDF : 208KB | 18/02/2025 LumiraDx Platform Instrument_LumiraDx_Advice regarding the use of the device PDF : 228KB | 18/02/2025 Spectra Optia Apheresis System_Terumo BCT Inc_Advice regarding the use of the device PDF : 127KB | 18/02/2025 Afinion HbA1c_Abbott Diagnostics Technologies AS_Advice regarding the use of the device PDF : 182KB | 18/02/2025 Infinity™ DBS System_Abbott Neuromodulation_Advice regarding the use of the device PDF : 211KB | 18/02/2025 Capio™ SLIM Suture Capturing Device_Boston Scientific Corporation_Advice regarding a device removal PDF : 211KB | 18/02/2025 MEGADYNE™ MEGA SOFT™ and MEGA 2000™ Reusable Patient Return Electrodes_Megadyne Medical Products, Inc._Advice regarding the use of the device PDF : 213KB | 18/02/2025 LINQ™IIInsertable Cardiac Monitor_MedtronicInc_Advice regarding a device removal PDF : 157KB | 18/02/2025 HD Lightweight Pendulum Camera Head_Olympus Medical Systems Corporation_Advice regarding a device modification PDF : 230KB | 18/02/2025