Summary of Field Safety Notices May 2024

03/06/2024
Medical devices Summary of field safety notices (FSN)

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

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

Documents

CardioLab, ComboLab_GE Medical Systems Information Technologies, Inc_Advice regarding a device modification PDF : 227KB | 11/02/2025 BiPAP A30 Ventilator, BiPAP A40 Ventilator_Respironics Inc_Advice regarding the use of the device PDF : 569KB | 11/02/2025 HeartMate System Monitor_Thoratec Corporation_Advice regarding the use of the device PDF : 456KB | 11/02/2025 Trevo RetrieversMicrocatheters, FlowGate2, Distal Access Catheter (DAC) and Synchro_Stryker Neurovascular_Advice regarding a device removal PDF : 300KB | 11/02/2025 DBS Clinician Programmer Model A610, Pocket Adaptor for Deep Brain Stimulation 64001, 64002_Medtronic Inc_Advice regarding the use of the device PDF : 376KB | 11/02/2025 MEGADYNE MEGA SOFT Pediatric Patient Return Electrode_Megadyne Medical Products, Inc_Advice regarding a device removal PDF : 350KB | 11/02/2025 Advanta VXT and Flixene Vascular Grafts _Atrium Medical CorporationGetinge_Advice regarding a device removal (2) PDF : 585KB | 11/02/2025 Elecsys Troponin T hs_Roche Diagnostics GmbH _Advice regarding changes updates made to instructions for use PDF : 749KB | 11/02/2025 Avalon Ultrasound Transducer_Philips Medizin Systeme Böblingen GmbH_Advice regarding the use of the device PDF : 498KB | 11/02/2025 BD MultitestTM 6-Color TBNK and BD MultitestTM 6-Color TBNK with BD TrucountTM Tube_Becton, Dickinson and Company_Advice regarding a device removal PDF : 285KB | 11/02/2025 Centricity High Acuity Anesthesia_GE Healthcare Finland Oy_Advice regarding a software upgrade PDF : 273KB | 11/02/2025 g-MDU connections for MR systems_Philips Medical Systems Nederland B.V._Advice regarding the use of the device PDF : 317KB | 11/02/2025 VICRYL™ & VICRYL™ Plus, PDS™ II & PDS™ II Plus, MONOCRYL™ & MONOCRYL™ Plus Sutures_Johnson & Johnson International Ethicon LLC_Advice regarding a device removal PDF : 639KB | 11/02/2025 IMMULITE 2000 Anti-TGAb_Siemens Healthcare Diagnostics Products Ltd_Advice regarding a device removal PDF : 255KB | 11/02/2025 Fluido Trauma set Sterile_The Surgical Company International B.V._Advice regarding a device removal PDF : 222KB | 11/02/2025 Ganz Osteotome_Surgical Holdings_Advice regarding a device modification PDF : 291KB | 11/02/2025 Antrum Punch, Sphenoid Punch, Galea Spring Hook, Uvula Retractor, Optical Biopsy and Grasping Forceps, Optical Scissor_KARL STORZ SE & Co. KG_Advice regarding the use of the device PDF : 265KB | 11/02/2025 PIC iX, PIC iX Expand_Philips Medical Systems_ Advice regarding a software upgrade PDF : 226KB | 11/02/2025 Ascenda™ Intrathecal Catheter_Medtronic_Advice regarding a device modification PDF : 177KB | 11/02/2025 Total Bilirubin Vanadate Oxidation Method_Randox Laboratories Ltd_Advice regarding changes updates made to instructions for use PDF : 64KB | 11/02/2025 Carescape multi-parameter patient monitors_GE Healthcare Finland Oy_Advice regarding the use of the device PDF : 194KB | 11/02/2025 Roche Diabetes Care Platform_Roche Diabetes Care GmbH_ Advice regarding a software upgrade PDF : 302KB | 11/02/2025 Philips Hemodynamic System_Philips Medical Systems Nederland BV_Advice regarding a software upgrade PDF : 326KB | 11/02/2025 High Voltage Capacitor Component (Blackwell and Polaris Devices)_Medtronic Inc_Advice regarding a device removal PDF : 140KB | 11/02/2025 Britepro Solo Single-Use Fiber Optic Laryngoscope_Flexicare Medical Limited_Advice regarding a device removal PDF : 332KB | 11/02/2025 Height Adjustable (HA) FlexTrak Trolley_Philips Medical Systems Nederland BV_Advice regarding the use of the device PDF : 249KB | 11/02/2025 Randox HbA1c Calibrator Set_Randox Laboratories Ltd_Advice regarding changes updates made to instructions for use PDF : 86KB | 11/02/2025 ClearCut Dual Bevel Sideport and A-OK CornealScleral V-Lance Ophthalmic knives_Alcon Laboratories, Inc._Advice regarding the use of the device PDF : 155KB | 11/02/2025 Cusa Excel 23kHz Straight Handpiece_Integra LifeSciences (Ireland) Limited_Advice regarding a device removal_HCP FSN PDF : 893KB | 11/02/2025 Cusa Excel 23kHz Straight Handpiece_Integra LifeSciences (Ireland) Limited_Advice regarding a device removal_ Distributor FSN PDF : 639KB | 11/02/2025 HAMILTON-C6_Hamilton Medical AG_Advice regarding a software upgrade PDF : 381KB | 11/02/2025 DxI 9000 Access Immunoassay Analyzer_Beckman Coulter_Advice regarding the use of the device_FSN1 PDF : 157KB | 11/02/2025 BIOFIRE FILMARRAY TORCH Base_BioFire Diagnosticss, LLC_Advice regarding the use of the device DOCX : 96KB | 11/02/2025 DxI 9000 Access Immunoassay Analyzer_Beckman Coulter_Advice regarding the use of the device_FSN2 PDF : 177KB | 11/02/2025