Summary of Field Safety Notices February 2025

11/03/2025
Medical devices Summary of field safety notices (FSN)

We have published a monthly summary of Field Safety Notices (FSN) affecting the Irish market for February 2025 below. 

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

Documents

Laparascopic IrrigationSuction Set_Fairmont Medical Products_Advice regarding the use of the device PDF : 126KB | 11/03/2025 Helix Elite Inactivated QC Sets and Panels_Microbiologics, Inc._Advice regarding a device removal PDF : 406KB | 11/03/2025 3PLUS 1 ® Multilevel Plasma Calibrator Set, MassTox® Antimycotic DrugsEXTENDED, MassCheck® Antimycotic DrugsEXTENDED Plasma Control Level I and II_Chromsystem PDF : 2.42MB | 11/03/2025 Flex-Pusher II in Occlutech ASD, mVSD, PmVSD Occluder Procedure Pack_Occlutech AB International_Advice regarding a device removal PDF : 264KB | 11/03/2025 FilmArray® Gastrointestinal (GI) Panel_BioFire Diagnostics, LLC_Advice regarding changesupdates made to instructions for use PDF : 321KB | 11/03/2025 DLP Aortic Root Cannula with Flow-Guard,DLP Aortic Root Cannula with Flow-Guard Introducer, MiAR Aortic Root Cannula wuth Flow- Guard_Medtronic, Inc._Advice r PDF : 387KB | 11/03/2025 Dexcom G6 Receicer_Dexcom_Advice regarding a software upgrade PDF : 243KB | 11/03/2025 EdgeTaper Platinum, EdgeTaper, EdgeGlide Path, EdgeFile X7, EdgeOne Fire GlidePath, Edgeone Fire_US Endodontics_Advice regarding a device removal PDF : 679KB | 11/03/2025 Various Uniflow Coaxial Breathing Systems PDF : 533KB | 11/03/2025 DxI 9000 Access Immunoassay Analyzer_Beckman Coulter_Advice regarding the use of the device_CRN00G1XR PDF : 65KB | 11/03/2025 Hedia Diabetes Assistant_Hedia ApS, Denmark_Advice regarding a software upgrade PDF : 135KB | 11/03/2025 Heater Cooler Unit HCU 40_Maquet Cardiopulmonary GmbH_Advice regarding a device modification PDF : 290KB | 11/03/2025 DxI 9000 Access Immunoassay Analyzer_Beckman Coulter_Advice regarding the use of the device PDF : 154KB | 11/03/2025 Intubation ORALNASAL Endotracheal Tube_ICU Medical Inc_Advice regarding a device removal PDF : 275KB | 11/03/2025 Dreeft wheels_EPPUR_Advice regarding changesupdates made to instructions for use PDF : 324KB | 11/03/2025 Infinity® Central Station _Draeger Medical System, Inc._Advice regarding the use of the device PDF : 1.27MB | 11/03/2025 Transystem Specimen collection device 900-0370_Copan Italia S.p.A_Advice regarding a device removal PDF : 645KB | 11/03/2025 Spectral CT, Spectral CT Plus_Philips Medical Systems Nederland B.V._Advice regarding the use of the device PDF : 514KB | 11/03/2025 Spectral CT 7500, Spectal CT on Rails_Philips Medical Systems Nederland B.V._Advice regarding the use of the device PDF : 374KB | 11/03/2025 Precision Thin Blades_Stryker Instruments a division of Stryker Corporation_Advice regarding a device removal PDF : 322KB | 11/03/2025 Atellica CH Diluent_Siemens Healthcare Diagnostics Inc_Advice regarding a device removal PDF : 291KB | 11/03/2025 VARIPULSE Bi Directional Catheter_Biosense Webster Inc_Advice regarding changes updates made to instructions for use PDF : 381KB | 11/03/2025 Origin Data Management _Brainlab AG_Advice regarding the use of the device PDF : 381KB | 11/03/2025 ORTHOPILOT CAP EINMAL-MARKER - ORTHOPILOT CAP SINGLE-USE MARKERS PDF : 472KB | 11/03/2025 MiniCap Extended Life PD Transfer Sets with Twist_Baxter Healthcare SA (CH-MF-000026124)_Advice regarding the use of the device PDF : 323KB | 11/03/2025 Soltive Fiber Stripper, Soltive Fiber Cleaver_Gyrus ACMI, Inc. (Olympus Surgical Technologies America)_Advice regarding a device removal PDF : 119KB | 11/03/2025 Oxylog 3000 plus_Drägerwerk AG & Co. KGaA_Advice regarding changesupdates made to instructions for use_Attachment PDF : 254KB | 11/03/2025 Assurity and Endurity Pacemakers_Abbott Medical_Advice regarding the use of the device PDF : 143KB | 11/03/2025 Pipeline Vantage Embolization Device with Shield Technology_Micro Therapeutics, Inc._Advice regarding a device removal PDF : 197KB | 11/03/2025 Access 2 Immunoassay Analyzer_Beckman Coulter_Advice regarding the use of the device PDF : 227KB | 11/03/2025 Welch Allyn non-automated blood pressure gauges_Welch Allyn, Inc._Advice regarding the use of the device PDF : 189KB | 11/03/2025 BIOFIRE Pneumoniaplus (PNplus) Panel_BioFire Diagnostics, LLC_Advice regarding a software upgrade PDF : 342KB | 11/03/2025 PHYSIO-ASSIST S.A.S, Simeox_H_EU, advice regarding update to IFU PDF : 141KB | 11/03/2025 Microstream Advance and Microstream Luer Sampling Lines_Covidien llc_Advice regarding changesupdates made to instructions for use PDF : 302KB | 11/03/2025 MiniMed™ Paradigm™, MiniMed™ 600 series, and MiniMed™ 700 series insulin pump systems_Medtronic Minimed_Advice regarding the use of the device_HCP PDF : 152KB | 11/03/2025 ORTHOPILOT CAP EINMAL-MARKER ORTHOPILOT CAP SINGLE-USE MARKERS_Aesculap AG_Advice regarding a device removal PDF : 366KB | 11/03/2025 Oxylog 3000 plus_Drägerwerk AG & Co. KGaA_Advice regarding changesupdates made to instructions for use PDF : 86KB | 11/03/2025 MiniMed™ Paradigm™, MiniMed™ 600 series, and MiniMed™ 700 series insulin pump systems_Medtronic Minimed_Advice regarding the use of the device_User PDF : 180KB | 11/03/2025 LIFECODES PF4 IgG and LIFECODES PF4 Enhanced_Immucor GTI Diagnostics (A Werfen Company)_Advice regarding the use of the device PDF : 301KB | 11/03/2025