Summary of Field Safety Notices January 2024

01/02/2024
Medical devices Summary of field safety notices (FSN)

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

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

Documents

Thunderbeat Type – S_Olympus Medical Systems Corporation_Advice regarding a device removal PDF : 272KB | 18/02/2025 PMAC71RSC - Reusable Sensor Cable for PM7100 and PMAC71RIC Reusable Infant Sensor Adapter Cable for PM7100_Medtronics_Advice regarding a device removal PDF : 642KB | 18/02/2025 SOLTIVE Single-use Laser Fibers_Gyrus ACMI, Inc. (Olympus Surgical Technologies America)_Advice regarding a device removal PDF : 86KB | 18/02/2025 Pyrocardan® TMC Resurfacing Implant_TORNIER SAS_Advice regarding a device removal PDF : 243KB | 18/02/2025 Philips Allura Xper, Allura Centron and Azurion_Philips Medical Systems Nederland BV_Advice regarding the use of the device PDF : 371KB | 18/02/2025 Perceval Plus Sutureless Aortic Heart Valve_Corcym S.r.l._Advice regarding a device removal PDF : 114KB | 18/02/2025 Panther Fusion SARS-CoV-2Flu ABRSV Assay_Hologic Inc._Advice regarding the use of the device PDF : 160KB | 18/02/2025 icotec Torque Wrench_icotec ag_Advice regarding a device removal PDF : 80KB | 18/02/2025 iCHAIR SKY ; 1.620_Meyra GmbH_Advice regarding the use of the device PDF : 137KB | 18/02/2025 HRIS Acetabular Cup Cut Tips_Stryker Joint Replacement_Advice regarding a device removal PDF : 236KB | 18/02/2025 IC9-RS_GE Healthcare_Advice regarding a device removal PDF : 394KB | 18/02/2025 InSpace Medium_Ortho-Space Ltd._Advice regarding the use of the device PDF : 224KB | 18/02/2025 Integra Cranial Access Kit without drugs, bits_Integra Pain Management_Advice regarding a device removal PDF : 218KB | 18/02/2025 Medfusion™ Syringe Infusion Pump_Smiths Medical_Advice regarding a device modification PDF : 228KB | 18/02/2025 da Vinci Xi and da Vinci X Surgical System_Intuitive Surgical, Inc._Advice regarding the use of the device PDF : 570KB | 18/02/2025 Everest 30 Inflation Device_Medtronic Inc._Advice regarding a device removal PDF : 298KB | 18/02/2025 Emergency Chest Re-opening Pack_Mölnlycke Health Care AB_Advice regarding a device removal PDF : 118KB | 18/02/2025 Evis Lucera Elite Bronchofibervideoscopes_Olympus Medical Systems Corporation_Advice regarding changesupdates made to instructions for use PDF : 401KB | 18/02/2025 Centricity Anesthesia Critical Care_GE Healthcare_Advice regarding the use of the device PDF : 175KB | 18/02/2025 cobas® SARS-CoV-2 & Influenza AB_Roche Molecular Systems, Inc_Advice regarding the use of the device_FSN2 PDF : 284KB | 18/02/2025 Captus 4000e Thyroid Uptake System_Mirion Technologies (Capintec), Inc._Advice regarding the use of the device PDF : 213KB | 18/02/2025 AMICA-GEN_HS Hospital Service SpA_Advice regarding the use of the device PDF : 311KB | 18/02/2025 Atellica UAS 800 Analyzer, Atellica 1500 Automated Urinalysis System_Siemens Healthcare Diagnostics Inc._Advice regarding the use of the device PDF : 217KB | 18/02/2025 ARTIS iconopheno system_Siemens Healthineers_Advice regarding changesupdates made to instructions for use PDF : 531KB | 18/02/2025 Alinity s System_Abbott Laboratories_Advice regarding a software upgrade PDF : 192KB | 18/02/2025 cobas® SARS-CoV-2 & Influenza AB_Roche Molecular Systems Inc_Advice regarding the use of the device_FSN3 PDF : 359KB | 18/02/2025 BD Sensi-Disc_Becton, Dickinson and Company_Advice regarding the use of the device PDF : 314KB | 18/02/2025 DxI 9000 Immunoassay Analyzer _Beckman Coulter _Advice regarding the use of the device PDF : 193KB | 18/02/2025 3M™ Surgical 3M™ Specialty Clipper Blades_3M Company_Advice regarding changesupdates made to instructions for use PDF : 287KB | 18/02/2025 Alinity s System_Abbott Laboratories_Advice regarding the use of the device PDF : 170KB | 18/02/2025 Alinity i Anti-HBs Reagent Kit_Abbott Ireland Diagnostic Division_Advice regarding a device removal PDF : 165KB | 18/02/2025