Summary of Field Safety Notices December 2025

06/01/2026
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 2025 below. 

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

Documents

Checkcell_Immucor Inc_Advice regarding a device removal PDF : 225KB | 19/12/2025 Carestation 600 and 700 series_GE healthcare_Advise regarding device correction PDF : 117KB | 30/12/2025 Creatinine Kinase CK-NAC_Randox Laboratories Ltd_Advice regarding a device removal PDF : 47KB | 28/11/2025 CAMHB WLHB and BRUCELLA BROTH 11ml_Remel Inc_ Advice regarding a device removal PDF : 283KB | 25/11/2025 Cobas c 703 analytical unit_Roche Diagnostics GmbH_ Advice regarding the use of a device PDF : 343KB | 09/12/2025 DataLinQ 2PAD_Fysicon B.V._Advice regarding a software upgrade PDF : 116KB | 09/12/2025 Flexor Check-Flo Introducer Set and the Rosch-Uchida Transjugular Liver Access Set_Cook Incorporated_Advice regarding a device removal PDF : 260KB | 24/11/2025 BD neXus V700 Infusion Pump & S700 Syringe Pump _Medcaptain_Advise on use of device PDF : 1.77MB | 30/12/2025 KWIK-STIK and LYFO DISK controls_Microbiologics_Advice regarding a lot removal PDF : 335KB | 05/12/2025 Philips Azurion R2.1.10 and R.2.2.10 systems_Philips Medical Systems_Advice regarding a software update PDF : 363KB | 12/12/2025 PALACOS® and COPAL® Pro Systems_Heraeus Medical GmbH_Advice regarding changesupdates made to instructions for use PDF : 166KB | 04/12/2025 Efficia DFM100 DefibrillatorMonitor_Philips Goldway Industrial Inc._Advice regarding a software upgrade PDF : 606KB | 11/12/2025 Permobil M and F series with Corpus seating system_Permobil AB_Advice regarding a device modification PDF : 205KB | 05/12/2025 UniCel DxI 600 and UniCel DxI 800_Beckman Coulter_Advice Regarding the Use of the Device PDF : 253KB | 19/11/2025 RADspeed safire and RADspeed Pro Ceiling Type X Ray Tube Support CH-200 and CH-200M_Shimadzu Corporation_Advice regarding a device modification PDF : 391KB | 07/10/2025 Synthes Cutting Tools - DePuy Synthes Saw Blades_Synthes GmbH Swizterland_Advice regarding a product removal PDF : 139KB | 02/12/2025 Philips Azurion R3.1 systems_Philips Medical Systems_Advice regarding a software update PDF : 326KB | 12/12/2025 Vanta LT Clinician Programmer_Medtronic, Inc_Advice regarding a software upgrade PDF : 119KB | 30/12/2025 Tempus Pro Patient Monitor_Remote Diagnostic Technologies Ltd._Advice regarding the use of the device PDF : 422KB | 25/11/2025 2 Cell Antibody Screen_NHSBT_Advice regarding the use of the device PDF : 89KB | 11/12/2025 Zimmer® Air Dermatome and Zimmer® Dermatome AN_Zimmer Surgical_Advice regarding a device removal PDF : 505KB | 18/12/2025 ACCESS PORT KIT, WOUND RETRACTOR_Intuitive Surgical_Advice regarding a device removal PDF : 433KB | 16/12/2025 Alinity ci-series System Control Module (SCM)_Abbott Laboratories_Advice regarding the use of the device PDF : 188KB | 13/11/2025 AEQUALIS, DARCO, EVOLVE, G-FORCE, HUNTER, ORTHOLOC_Wright Medical Technology Inc_Advice regarding a device removal PDF : 764KB | 01/12/2025 Automated Tube Sorter TS-10_Sysmex Europe SE_ Advice regarding the use of a device PDF : 1.1MB | 15/12/2025 MINOP Trocar 150mm 4 Wking Channel 6mm_Aesculap AG_Advice regarding the use of the device PDF : 2.64MB | 04/12/2025 Codman Microsensor and Cerelink ICP Basic Kits_Integra LifeSciences_advice regarding a device removal PDF : 445KB | 09/12/2025