Summary of Field Safety Notices December 2024

01/01/2025
Medical devices Summary of field safety notices (FSN)

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

The naming convention for each document is <product name><manufacturer name><the nature of the FSN>.

Documents

Haemostatic forceps clamps_Aesculap AG_Advice regarding the use of the device PDF : 4.08MB | 06/02/2025 Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e_Maquet Critical Care AB_Advice regarding the use of the device_FSN3 PDF : 218KB | 06/02/2025 Figulla Flex II ASD Occluder_Occlutech GmbH_Advice regarding the use of the device PDF : 381KB | 06/02/2025 Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e_Maquet Critical Care AB_Advice regarding the use of the device_FSN1 PDF : 152KB | 06/02/2025 Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e_Maquet Critical Care AB_Advice regarding the use of the device_FSN2 PDF : 147KB | 06/02/2025 DLP™ Pediatric One-Piece Artierial Cannualae,EOPA™ Arterial Cannula, SelectSeries Arterial Cannula_Medtronic_Advice regarding a device removal PDF : 284KB | 06/02/2025 EVO IQ Large Volume Pump_Baxter Healthcare SA_Advice regarding a software upgrade PDF : 285KB | 06/02/2025 CyberKnife® System Standard Treatment Couch_Accuray Incorporated_Advice regarding a device modification PDF : 253KB | 06/02/2025 Coloplast urology devices_Coloplast AS_Advice regarding a device removal PDF : 227KB | 06/02/2025 BD PCR Cartridge_Becton, Dickinson and Company_Advice regarding the use of the device PDF : 256KB | 06/02/2025 OR light systems_KLS Martin SE & Co. KG_Advice regarding the use of the device PDF : 1.02MB | 06/02/2025 Single Use Mechanical Lithotriptor V_Olympus Medical Systems Corporation_Advice regarding a device removal PDF : 770KB | 06/02/2025 SpeedControl Dial used with the Smartdrive MX2 _Max Mobility LLC_Advice regarding a device modification PDF : 145KB | 06/02/2025 Thunderbeat Type –S_Olympus Medical Systems Corporation_Advice regarding the use of the device PDF : 264KB | 06/02/2025 XpertXpressCoV-2plusXpertXpressCoV-2FluRSVplus_Cepheid_Advice regarding the use of the device_Follow-up FSN PDF : 119KB | 06/02/2025 Atellica CH Immunoglobulin M_2 (IgM_2)_Siemens Healthcare Diagnostics Inc_Advice regarding the use of the device PDF : 250KB | 06/02/2025 SynchroMed™ Clinician Programmer Application_Medtronic_Advice regarding the use of the device PDF : 192KB | 06/02/2025 UNiD™ Adaptive Spine Intelligence_MEDICREA INTERNATIONAL SAS_Advice regarding the use of the device PDF : 1.09MB | 06/02/2025 AXIOS Stent and Electrocautery Enhanced Delivery System_Boston Scientific Corporation_Advice regarding a device removal PDF : 218KB | 06/02/2025 Tec 6 Plus, Tec 820, Tec 850_Datex-Ohmeda_Advice regarding the use of the device PDF : 284KB | 06/02/2025 Sterile Percutaneous Reference Pin_Medtronic Navigation Inc._Advice regarding a device removal PDF : 343KB | 06/02/2025 TruSystem 7000_Baxter Medical Systems GmbH Co. KG_Advice regarding a device modification PDF : 201KB | 06/02/2025 3M™ Transbond™ Self-Etching Primer_3M Unitek Corporation_Advice regarding a device removal PDF : 172KB | 06/02/2025 ACCOLADE Family of Pacemakers and CRT-Ps_Cardiac Pacemaker Inc - Boston Scientific Corporation_Advice regarding the use of the device PDF : 267KB | 06/02/2025 MICROPURE 123 and ISOPURE 123_BVI LiegePhysIOL_Advice regarding the use of the device PDF : 286KB | 06/02/2025 ROTEM sigma complete ROTEM sigma complete hep_Werfen_Advice regarding the use of the device PDF : 412KB | 06/02/2025 Infinia, VariCamVGVH, Brivo NM 615, Discovery NM 630, Discovery NMCT 670, and Optima NMCT 640 Nuclear Medicine systems_GE Medical Systems_Advice regarding the use of the device DOCX : 499KB | 06/02/2025 HemosIL Heparin Calibrators_Instrumentation Laboratory Co._Advice regarding the use of the device PDF : 190KB | 06/02/2025 PRISMAX V2 ROW_Baxter Healthcare SA_Advice regarding a software upgrade PDF : 209KB | 06/02/2025 Infinia, VariCamVGVH, Brivo NM 615, Discovery NM 630, Discovery NMCT 670, and Optima NMCT 640 Nuclear Medicine systems_GE Medical Systems_Advice regarding the use of the device PDF : 869KB | 06/02/2025 HLM tubing set_HMT Medizintechnik GmbH_Advice regarding a device removal PDF : 765KB | 06/02/2025 MAJ-891 ForcepsIrrigation Plug used with Cytoscope, Ureteroscope, Choledochoscope, Hysteroscope and Ventriculoscope_Olympus Medical Systems Corporation_Use of the device PDF : 385KB | 06/02/2025 MC Hemo, CHC Hemo_Change Healthcare Canada Company_Advice regarding a software upgrade PDF : 272KB | 06/02/2025 Haemostatic forceps clamps_Aesculap AG_Advice regarding the use of the device_Follow up FSN PDF : 6.92MB | 06/02/2025