Summary of Field Safety Notices October 2024

01/11/2024
Medical devices Summary of field safety notices (FSN)

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

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

Documents

AQUAULTRACLEAR ULTRASOUND GEL260g_Ultragel Medical Kft_Advice regarding a device removal PDF : 6.1MB | 12/02/2025 MiniCap Extended Life PD transfer_Baxter Healthcare_Advice regarding the use of the device PDF : 291KB | 12/02/2025 MiniMed pumps_Medtronic_Advice regarding a device modification  _FSN_ Pump User Letter Prime Pump Only PDF : 405KB | 12/02/2025 MEERA Operating Table_Maquet GmbH_Advice regarding the use of the device PDF : 197KB | 12/02/2025 MAJ-1555 Single Use Biopsy Valve_Olympus Medical Systems Corporation_Advice regarding the use of the device PDF : 427KB | 12/02/2025 IPPB Flextube™ Breathing Systems_IntersurgicaL Ltd._Advice regarding the use of the device PDF : 543KB | 12/02/2025 HCYS_Roche Diagnostics GmbH_Advice regarding the use of the device PDF : 26KB | 12/02/2025 Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e_Maquet Critical Care AB_Advice regarding the use of the device_FSN PDF : 272KB | 12/02/2025 Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e_Maquet Critical Care AB_Advice regarding the use of the device_FSN_Follow Up PDF : 175KB | 12/02/2025 Gynko Sterile Single Use Disposable Hysteroscopy sheath _Cover SRL_Advice regarding changesupdates made to instructions for use PDF : 208KB | 12/02/2025 Giraffe Omnibed Carestation CS1, Giraffe Omnibed_Datex-Ohmeda, Inc_Advice regarding the use of the device PDF : 327KB | 12/02/2025 Halyard CPT 51-090544 and Q68419 containing Codman® Surgical Patties & Surgical Strips_ArcRoyal uc, an Owens & Minor Company_Advice regarding a device removal PDF : 227KB | 12/02/2025 Hemospray Endoscopic Hemostat_Cook EndoscopyWilson Cook Medical, Inc._Advice regarding a device removal PDF : 176KB | 12/02/2025 McGRATH MAC Video Laryngoscope _Covidien LLC_Advice regarding a device removal PDF : 137KB | 12/02/2025 Evis Exera III Gastrointestinal Videoscope_Olympus Medical Systems Corporation_Advice regarding changesupdates made to instructions for use PDF : 686KB | 12/02/2025 Atlan Family_Drägerwerk AG & Co. KGaA_Advice regarding the use of the device PDF : 801KB | 12/02/2025 Atellica CH Reaction Cuvette Segment_Siemens Healthcare Diagnostics Inc_Advice regarding a device removal_FSN_A PDF : 753KB | 12/02/2025 Codman® Surgical Patties & Surgical Strips_Unisurge International Limited_Advice regarding a device removal PDF : 442KB | 12/02/2025 Codman® Surgical Patties & Surgical Strips_Integra LifeSciences Mansfield_Advice regarding a device removal PDF : 223KB | 12/02/2025 CORTRAK 2 Enteral Access System (EAS)_Avanos Medical, Inc._Advice regarding a software upgrade_FSN_B PDF : 164KB | 12/02/2025 cobas® Influenza AB & RSV UC for use on the cobas® 68008800 Systems_Roche Molecular Systems, Inc._Advice regarding the use of the device PDF : 166KB | 12/02/2025 Accu-Chek Care_Roche Diabetes Care GmbH_Advice regarding a software upgrade PDF : 158KB | 12/02/2025 Vue PACS (Diagnostic)_Philips Medical Systems Nederland BV_Advice regarding a software upgrade PDF : 462KB | 12/02/2025 Ambu® VivaSight™ 2 DLT_Ambu AS_Advice regarding a device removal PDF : 288KB | 12/02/2025 4Fr Single-Lumen Power PICC Catheters_Bard Access Systems, Inc_Advice regarding the use of the device PDF : 348KB | 12/02/2025 Actim Partus Test_Actim Oy_Advice regarding a device removal PDF : 1.75MB | 12/02/2025 Centricity Universal Viewer Zero Footprint Client_GE Healthcare_Advice regarding a software upgrade PDF : 149KB | 12/02/2025 CORTRAK 2 Enteral Access System (EAS)_Avanos Medical, Inc._Advice regarding a software upgrade_FSN_A PDF : 220KB | 12/02/2025 Atellica CH Reaction Cuvette Segment_Siemens Healthcare Diagnostics Inc_Advice regarding a device removal_FSN_B PDF : 712KB | 12/02/2025 10mm Flextube Resus Breathing Systems, Neopuff_IntersurgicaL Ltd._Advice regarding a device removal PDF : 130KB | 12/02/2025 Approach CTO & Approach Hydro ST Micro WireGuide_Cook Incorporated_Advice regarding a device removal_FSN PDF : 171KB | 12/02/2025 Approach CTO & Approach Hydro ST Micro WireGuide_Cook Incorporated_Advice regarding a device removal_FSN Attachement PDF : 127KB | 12/02/2025 AMS 800™ Artificial Urinary Sphincter_Boston Scientific Corporation_Advice regarding a device removal PDF : 229KB | 12/02/2025 RAPIDPoint 500 Systems Measurement Cartridge_Siemens Healthcare Diagnostics Inc._Advice regarding the use of the device PDF : 196KB | 12/02/2025 Side Guards_Panthera AB_Patricija Pavelskopfa_CRN00FRQZ_Panthera AB PDF : 1005KB | 12/02/2025 POLARx & POLARx FIT Cryoablation Balloon Catheters_Boston Scientific Corporation_Advice regarding the use of the device PDF : 225KB | 12/02/2025 SoKINOX ServiNO Monnal iNO_INOSYSTEMS_Advice regarding the use of the device_FSN_Service Personnel PDF : 145KB | 12/02/2025 Venclose™ RF Ablation Catheter_Venclose, Inc._Advice regarding the use of the device PDF : 306KB | 12/02/2025 UroPass® Ureteral Access Sheath Set_Gyrus ACMI, Inc. (Olympus Surgical Technologies America)_Advice regarding the use of the device PDF : 281KB | 12/02/2025 XpertXpressCoV-2plusXpertXpressCoV-2FluRSVplus_Cepheid_Advice regarding the use of the device PDF : 125KB | 12/02/2025 Wound Care Dressings (Multitude)_Advanced Medical Solutions_Advice regarding a device removal PDF : 526KB | 12/02/2025 Philips Zenition 50 & Philips Zenition 70_Philips Medical Systems Nederland BV_Advice regarding a device modification PDF : 862KB | 12/02/2025 TruSystem 7000_Baxter Medical Systems GmbH Co. KG_Advice regarding a device modification PDF : 196KB | 12/02/2025 paraPAC Plus™ ventilators_Smiths Medical ASD Inc. (currently ICU Medical Inc.)_Advice regarding the use of the device (2) PDF : 183KB | 12/02/2025 Philips Intera, Achieva, Ingenia CX_Philips Healthcare_Advice regarding a software upgrade PDF : 162KB | 12/02/2025 SoKINOX ServiNO Monnal iNO_INOSYSTEMS_Advice regarding the use of the device_FSN_USER PDF : 220KB | 12/02/2025 Silicone Oil_Dutch Ophthalmic Research Center (International) B.V._Advice regarding the use of the devic PDF : 80KB | 12/02/2025 Reusable and Single Use Flow Sensors_SLE Ltd_Advice regarding a device removal PDF : 136KB | 12/02/2025 Outer sheath, 22.5 Fr (for rigid cystoscope) _Olympus Winter & Ibe GmbH_Advice regarding the use of the device PDF : 109KB | 12/02/2025 paraPAC Plus™ ventilators_Smiths Medical ASD Inc. (currently ICU Medical Inc.)_Advice regarding the use of the device PDF : 180KB | 12/02/2025 Orchestra- and Pilot-Series_Fresenius Kabi_Advice regarding the use of the device PDF : 149KB | 12/02/2025 OLYMPUS Sol ve™ SuperPulsed Laser System_Gyrus ACMI, Inc. (Olympus Surgical Technologies America)_Advice regarding changesupdates made to instructions for use PDF : 171KB | 12/02/2025 MiniMed pumps_Medtronic_Advice regarding the use of the device_FSN_pump user PDF : 180KB | 12/02/2025 MiniMed pumps_Medtronic_Advice regarding the use of the device_FSN-HCP PDF : 208KB | 12/02/2025 NextSeq 550Dx MiSeq Dx NovaSeq 6000Dx_Illumina, Inc._Advice regarding the use of the device PDF : 146KB | 12/02/2025 MiniMed pumps_Medtronic_Advice regarding a device modification  _FSN_Pump User Letter PDF : 402KB | 12/02/2025 MiniMed pumps_Medtronic_Advice regarding a device modification  _FSN_HCP PDF : 169KB | 12/02/2025 My life App_SINOVO health solutions GmbH_Advice regarding a software upgrade PDF : 139KB | 12/02/2025 Nasopharyngeal Airway 6.0MM 10BX, Nasopharyngeal Airway 7.0MM 10BX, Nasopharyngeal Airway 8.0MM 10BX, 15mm Double Swivel Connector 10BX_ICU Medical Inc_Advice regarding a device re PDF : 232KB | 12/02/2025