Summary of Field Safety Notices May 2025

10/06/2025
Medical devices Summary of field safety notices (FSN)

We have published a monthly summary of Field Safety Notices (FSN) affecting the Irish market for May2025 below. 

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

Documents

Copeland Fetal Scalp Electrodes_Rocket Medical_ZDOCK167 IFU Rev. 17 PDF : 554KB | 10/06/2025 Philips Azurion_Philips Allura Xper_Philips Medical Systems_Advice regarding the use of the device_Follow up FSN PDF : 492KB | 10/06/2025 Olympic Brainz Monitor (Digital Acquisition Box)_Natus Medical_Advice regarding a device removal PDF : 261KB | 10/06/2025 Medumat Standard Ventilator_ Weimann Emergency Medical Technology_ Advice regarding device removal_ CRN00GC7Z PDF : 322KB | 10/06/2025 Centricity High Acuity Critical Care Anesthesia systems_ GE Healthcare_Advice regarding use of device_CRN00GCFH PDF : 150KB | 10/06/2025 Extended Tip Applicator (XTA)_INTEGRA LIFESCIENCES CORPORATION_Advice regarding a device removal PDF : 309KB | 10/06/2025 Micromyst® Applicator_INTEGRA LIFESCIENCES CORPORATION_Advice regarding a device removal PDF : 293KB | 10/06/2025 REAL 9000 PLUS, REAL 9200 TWIN, REAL 6100 PLUS_Mercado Medic AB_Advice regarding a device modification PDF : 412KB | 10/06/2025 BIOFIRE® Blood Culture Identification 2 (BCID2) Panel_BioMérieux UK Ltd_Advice regarding the use of the device PDF : 320KB | 10/06/2025 System 6,7,8,9 Reciprocating-Sternum Saw_Stryker Instruments_Advice regarding a device removal PDF : 861KB | 10/06/2025 Copeland Fetal Scalp Electrode_Rocket Medical_Advice regarding changes_updates made to IFU DOCX : 140KB | 10/06/2025 All consumables produced by MEDTRON AG_Advice regarding use of the device PDF : 165KB | 10/06/2025 ENDOPATH ECHELON™ Vascular White Reload_ETHICON ENDO-SURGERY_Advice regarding the use of the device PDF : 416KB | 10/06/2025 DxI 9000 Access Immunoassay Analyzer_Beckman Coulter_Advice regarding the use of the device_CRN00G8KH PDF : 162KB | 10/06/2025 CADD Solis Ambulatory Infusion Pumps_ICU Medical_Advice regarding changes made to IFU PDF : 153KB | 10/06/2025 CADD Solis Ambulatory Infusion Pumps_ICU Medical_Advice regarding software update PDF : 152KB | 10/06/2025 REMISOL Advance_Beckman Coulter_Advice regarding the use of the device PDF : 212KB | 10/06/2025 Novastar Plus & Novastar TS_Drägerwerk AG & Co. KGaA_Advice regarding changes made to IFU_Follow up FSN_V53809 PDF : 57KB | 10/06/2025 CADD Solis Ambulatory Infusion Pump_ICU Medical Inc_Advice regarding the use of device PDF : 156KB | 10/06/2025 Alinity m Resp-4-Plex AMP Kit_Abbott Molecular Inc_Advice regarding a device removal PDF : 141KB | 10/06/2025 DxI 9000 Access Immunoassay Analyzer_Beckman Coulter_Advice regarding the use of the device_CRN00G8KL PDF : 189KB | 10/06/2025 Universal Joint Screwdriver_Stryker Instruments_Advice regarding a device removal PDF : 197KB | 10/06/2025 MR systems with SW versions R11.1 and R12.1_Philips Medical Systems Nederland B.V._Advice regarding a software update PDF : 517KB | 10/06/2025 Sample probe_Beckman Coulter, Inc._Advice regarding a device removal PDF : 557KB | 10/06/2025 Constellation Total Plus Pak_Alcon Laboratories Inc._Advice regarding device removal PDF : 374KB | 10/06/2025 Ortho Vision and Vision Max Anayzers_QuidelOrtho_Advice regarding the use of the device PDF : 97KB | 10/06/2025 Hugo™ RAS Tower_Covidien llc_Advice regarding a software upgrade PDF : 263KB | 10/06/2025 Soltive Laser System_Olympus_Advice regarding the use of the device PDF : 578KB | 10/06/2025 Texium Needle-Free Syringe, Male luer_ BD_Advic regarding device removal PDF : 332KB | 10/06/2025 Instramed Thread Retriever and Instramed Medium Dressing Pack_Farla Medical Healthcare Ltd_Advice regarding a device removal PDF : 187KB | 10/06/2025 Panel 1_NHSBT_Advice regadring the use of the device PDF : 63KB | 10/06/2025 4Fr Single Lumen PowerPICC_Bard Access Systems_ Product Removal _Follow Up FSN(2) PDF : 306KB | 10/06/2025 Otopore&Nasopore_ Stryker Instruments_Advice regarding a device removal PDF : 312KB | 10/06/2025 Days adjustable crutch (standard)_Performance Health International Ltd_Advice regarding a device removal PDF : 270KB | 10/06/2025 Evis Exera III Duodenovideoscope, Evis Lucera Elite Duodenovideoscope, TJF-Q170V Duodenovideoscope_Olympus Medical Systems Corporation_Advice regarding changes made to the IFU PDF : 323KB | 10/06/2025 CHC Hemo_Change Healthcare Canada Company_Advice regarding a software update PDF : 744KB | 10/06/2025 Instinct Plus Endoscopic Clipping Device_Cook Endoscopy Wilson Cook Medical_Advice regarding the user of the device PDF : 202KB | 10/06/2025 DxI 9000 Access Immunoassay Analyzer_Beckman Coulter_Advice regarding the use of the device_CRN00G98W PDF : 184KB | 10/06/2025 Whole Blood Collection Sets_Macopharna_Advice regarding device removal PDF : 279KB | 10/06/2025 Universa® Soft Ureteral Stent Set & Universa® Firm Ureteral Stent Set_Cook Medical_advice regarding a device removal PDF : 132KB | 10/06/2025 BD BACTEC™ MGIT™ 960 PZA Kit_Becton Dickinson_Product Removal PDF : 264KB | 10/06/2025 Alinity i Total PSA Reagent Kit_Abbott Ireland Diagnostics Division_Advice regarding a device removal PDF : 186KB | 10/06/2025 Centricity High Acuity Critical Care Anesthesia systems_ GE Healthcare_Advice regarding use of device_CRN00GCGQ PDF : 84KB | 10/06/2025