Summary of Field Safety Notices July 2024

01/08/2024
Medical devices Summary of field safety notices (FSN)

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

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

Documents

Aural Ventilation Tubes_Exmoor Plastics Limited_Advice regarding a device removal PDF : 1.14MB | 18/02/2025 Change Healthcare Cardiology_Change Healthcare Canada Company_Advice regarding the use of the device PDF : 413KB | 18/02/2025 Braun Thermoscan® Pro 6000_Welch Allyn, Inc._Advice regarding the use of the device PDF : 384KB | 18/02/2025 BioPince™, BioPinceUltra™ and TruCore™ II Automatic Biopsy Instruments_Argon Medical Devices, Inc. USA_Advice regarding a device removal PDF : 339KB | 18/02/2025 BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel_BioFire Diagnostics, LLC_Advice regarding the use of the device PDF : 287KB | 18/02/2025 CareLink Programmer_Medtronic Inc._Advice regarding a software upgrade PDF : 171KB | 18/02/2025 Centricity High Acuity Anesthesia_GE Healthcare Finland Oy_Advice regarding a software upgrade PDF : 254KB | 18/02/2025 Philips Respironics, Inc._Trilogy EVO_Advice regarding a software upgrade PDF : 502KB | 18/02/2025 BD BACTEC™ MGIT™ 960 PZA Kit_Becton Dickinson and Company_Advice regarding a device removal PDF : 304KB | 18/02/2025 SLE6000 Infant ventilator_Inspiration Healthcare_Advice regarding a device modification PDF : 260KB | 18/02/2025 PBiPaP Ventilators_Philips Respironics, Inc._Advice regarding the use of the device PDF : 543KB | 18/02/2025 Viva™, Brava™, Evera™, Evera MRI, Visia AF™, Visia AF MRI™, Primo MRI™, Mirro MRI™ , Claria MRI™, Amplia MRI™, Compia MRI™ CRT-Ds and ICDs_Medtronic Inc._Advice regardi PDF : 168KB | 18/02/2025 Vercise Genus™ Implantable Pulse Generator System_Boston Scientific Neuromodulation Corporation_Advice regarding a device modification PDF : 192KB | 18/02/2025 DEFIGARD Touch-7_Schiller Medical_Advice regarding a software upgrade PDF : 142KB | 18/02/2025 Products that contain a vacuum-tight version of a Venous Hardshell Cardiotomy Reservoir_Maquet Cardiopulmonary GmbH_Advice regarding a device removal PDF : 516KB | 18/02/2025 WaveWriter Alpha™ IPG Kit_Boston Scientific Neuromodulation Corporation_Advice regarding a device modification PDF : 156KB | 18/02/2025 VENTANA anti-CD10 (SP67) Rabbit Monoclonal Primary_Ventana Medical Systems Inc._Advice regarding a device removal PDF : 141KB | 18/02/2025 RAL Diff-Quik™ Fixative solution_RAL Diagnostics_Advice regarding the use of the device PDF : 87KB | 18/02/2025 Silicone Sheets, Discs and Strips_Exmoor Plastics Limited_Advice regarding the use of the device PDF : 210KB | 18/02/2025 FreeGo Pump_Zevex Inc. (doing business as Moog Medical Devices)_Advice regarding the use of the device PDF : 466KB | 18/02/2025 McGRATH MAC Video Laryngoscope_Covidien LLC_Advice regarding a device removal PDF : 390KB | 18/02/2025 NIM Contact™ EMG Reinforced Endotracheal Tubes and NIM™ Standard EMG Reinforced Endotracheal Tubes_Medtronic Xomed, Inc._Advice regarding a device removal PDF : 273KB | 18/02/2025 HeartMate 3 System Controller_Abbott Medical_Advice regarding the use of the device_FSN_Patients PDF : 417KB | 18/02/2025 Luminos Agile_S_iemens Healthcare GmbH_Advice regarding the use of the device PDF : 205KB | 18/02/2025 Philips Azurion R1.x_Philips Medical Systems Nederland BV_Advice regarding a software upgrade PDF : 282KB | 18/02/2025 Powerheart® G5 AED, Semi-Automatic, G5S_Zoll Medical Corporation_Advice regarding the use of the device PDF : 169KB | 18/02/2025 Hintermann Series H3 Total Ankle Replacement System_Dt MedTech_Advice regarding the use of the device PDF : 210KB | 18/02/2025 HeartStart Intrepid MonitorDefibrillator_Philips Goldway (Shenzhen) Industrial Inc._Advice regarding the use of the device PDF : 437KB | 18/02/2025 Luisa Ventilators LM150TD_ Löwenstein Medical Technology_Advice regarding a software upgrade PDF : 270KB | 18/02/2025 Kaltostat_Convatec Infusion Care_Advice regarding a device removal PDF : 781KB | 18/02/2025 Oncomine Dx Express Test Panel_Life Technologies Corporation_Advice regarding the use of the device PDF : 115KB | 18/02/2025 NIM™ Vital Nerve Monitoring System_Medtronic Xomed, Inc._Advice regarding a software upgrade PDF : 148KB | 18/02/2025 Delivery sets_Medline International France SAS_Advice regarding the use of the device PDF : 266KB | 18/02/2025 DxI 9000 Access Immunoassay Analyzer_Beckman Coulter_Advice regarding a device modification   (2) PDF : 178KB | 18/02/2025 HeartMate 3 System Controller_Abbott Medical_Advice regarding the use of the device PDF : 227KB | 18/02/2025 DxI 9000 Access Immunoassay Analyzer_Beckman Coulter_Advice regarding a device modification PDF : 181KB | 18/02/2025