Summary of Field Safety Notices April 2024

01/05/2024
Medical devices Summary of field safety notices (FSN)

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

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

Documents

HistoCore Pegasus and HistoCore Pegasus Plus_Leica BioSystems_Advice regarding the use of the device PDF : 2.05MB | 11/02/2025 Hintermann Series H3 Total Ankle Replacement (TAR) system_DT MedTech _Advice regarding the use of the device PDF : 3.42MB | 11/02/2025 Hintermann Series H3 Total Ankle Replacement (TAR) system_DT MedTech _Advice regarding the use of the device - Updated FSN PDF : 1.27MB | 11/02/2025 ARTERIOFIX ART.-KATH.-SET 20G 80MM_B Braun_Advice regarding a device removal PDF : 890KB | 11/02/2025 APC (Schneider Electric IT Corporation) UPS for PIC iX_Philips Medical Systems_Advice regarding the use of the device PDF : 749KB | 11/02/2025 Various Mapleson F Anaesthetic Breathing Systems_Intersurgical Ltd_Advice regarding the use of the device PDF : 247KB | 11/02/2025 Cup Removal Starter Instrument-54MM_Innomed, Inc._Advice regarding a device removal PDF : 324KB | 11/02/2025 HeartMate 3_Thoratec Corporation_Advice regarding the use of the device PDF : 115KB | 11/02/2025 NeoFit® screw_In2Bones SAS_Advice regarding a device removal PDF : 1.15MB | 11/02/2025 Vyaire Medical GmbH_Twin Tube and Twin Tube Probenschlauch_Advice regarding the use of the device PDF : 821KB | 11/02/2025 Software App 9735762 Stealth S8 Application V1.0.1, 1.0.2, 1.0.3, 1.1.0 and 1.2.0_Medtronic B.V US_Advice regarding a software upgrade PDF : 389KB | 11/02/2025 Epix UNIVERSAL CLIP APPLIER_Applied Medical Resources Corporation_Advice regarding a device removal PDF : 418KB | 11/02/2025 Electrosurgical Electrode_Dongguan QueenMed Equipment Mfg Co Ltd [EN]_Advice regarding a device removal PDF : 315KB | 11/02/2025 Coombs Anti-IgG, ID-DiaCell I-II-III, LISS Coombs_BioRad DiaMed GmbH_Advice regarding the use of the device PDF : 203KB | 11/02/2025 Cardiosave Intra-Aortic Balloon Pumps_Datascope Corp. Getinge_Advice regarding the use of the device PDF : 740KB | 11/02/2025 Supine 2 Multistander 2 Actuator_Jenx Ltd_Advice regarding a device modification PDF : 386KB | 11/02/2025 Esoflip Dilation Catheter_Covidien llc_Advice regarding a device removal PDF : 106KB | 11/02/2025 Randox Evidence MULTISTAT_Randox Laboratories Ltd._Advice regarding the use of the device PDF : 572KB | 11/02/2025 Sodium Chloride Irrigation, Eye Wash and inhalation Solution 0.9%_Legency Remedies Private Limited_Advice regarding a device removal PDF : 531KB | 11/02/2025 Sleepnet masks with magnets_Sleepnet_Advice regarding the use of the device PDF : 467KB | 11/02/2025 Antrum Punch, Sphenoid Punch, Galea Spring Hook, Uvula Retractor, Optical Biopsy, Grasping Forceps, Optical Scissor, Working Insert,_KARL STORZ SE & Co. KG_Advice on use of device PDF : 259KB | 11/02/2025 Philips MR systems_Philips Healthcare_Advice regarding the use of the device PDF : 369KB | 11/02/2025 Tempus LS_SCHILLER AG_Advice regarding changes updates made to instructions for use PDF : 372KB | 11/02/2025 HeartSine samaritan® PAD 350P 360P 450P 500P_HeartSine Technologies, Ltd. (Stryker Medical)_Advice regarding the use of the device PDF : 440KB | 11/02/2025 fabian HFO Classic and HFOi Ventilator_Acutronic Medical Systems AG_Advice regarding a software upgrade PDF : 944KB | 11/02/2025 EXETER 2.5 I M PLUG_Stryker Limerick_Advice regarding a device removal PDF : 306KB | 11/02/2025 Cardinal Health Monoject™ Syringes_Smith Medical_Advice regarding a device removal PDF : 235KB | 11/02/2025 LIAISON® BRAHMS PCT® II GEN_DiaSorin_Advice regarding changes updates made to instructions for use PDF : 409KB | 11/02/2025 BD BACTEC™ MicroMGIT Calibration Vial_Becton, Dickinson and Company_Advice regarding a device removal PDF : 261KB | 11/02/2025 DxI 9000 Access Immunoassay Analyzer_Beckman Coulter _Advice regarding the use of the device PDF : 137KB | 11/02/2025 Infinity Resection Guide Adjustment Block_Wright Medical Technology, Inc._Advice regarding a device removal PDF : 288KB | 11/02/2025 Patient Information Center iX_Philips Medizin Systeme Böblingen GmbH_Advice regarding a software upgrade PDF : 241KB | 11/02/2025 ProBP 3400, Spot Vision Screener_Welch Allyn, Inc. _Advice regarding the use of the device PDF : 183KB | 11/02/2025 Stylage M Lidocaine_Laboratoires Vivacy_Advice regarding a device removal PDF : 259KB | 11/02/2025 Portex Blue Line Siliconised PVC Tracheotomy Tube_Smith Medical_Advice regarding a device removal PDF : 222KB | 11/02/2025 Integra Cranial Access Kit without drugs, bits_Integra Pain Management_Advice regarding a device removal PDF : 184KB | 11/02/2025 FiberOptix Ultra 8 IAB, Ultra 8 IAB, UltraFlex IAB Catheters_Telefelx Inc_Advice regarding the use of the device PDF : 679KB | 11/02/2025 AIRVO2 Humidifier myAIRVO2 Humidifier_Fisher & Paykel Healthcare Ltd _Advice regarding a device removal_Distributor FSN PDF : 309KB | 11/02/2025 AIRVO2 Humidifier myAIRVO2 Humidifier_Fisher & Paykel Healthcare Ltd_Advice regarding a device removal_Healthcare Professional FSN PDF : 299KB | 11/02/2025 Vercise Genus™ Implantable Pulse Generator System_Boston Scientific Neuromodulation Corporation_Advice regarding a device modification PDF : 145KB | 11/02/2025 Multiva 1.5T_Philips Healthcare (Suzhou) Co., Ltd_Advice regarding the use of the device PDF : 437KB | 11/02/2025 Infinity® Acute Care System (M540)_Draeger Medical Systems, Inc. _Advice regarding a device modification PDF : 889KB | 11/02/2025