Summary of Field Safety Notices August 2024

02/09/2024
Medical devices Summary of field safety notices (FSN)

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

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

Documents

Braun Thermoscan Pro 6000_Welch Allyn Inc_Advice regarding the use of the device PDF : 1.26MB | 18/02/2025 ACUSON Juniper and ACUSON Maple_Siemens Medical Solutions USA, Inc. Ultrasound_Advice regarding a software upgrade PDF : 1.34MB | 18/02/2025 BD FACSDuet Sample Preparation Systems_Becton Dickinson and Company_Advice regarding a software upgrade PDF : 498KB | 18/02/2025 BD Phoenix M50 Automated Microbiology System Instrument BD Phoenix 100 Automated Microbiology System Instrument,_Becton Dickinson and Company_Advice regarding the use of the device PDF : 508KB | 18/02/2025 BLUSelect BLUgriggs and BLUperc Trach products_ICU Medical(Smith Medical)_Advice regarding a device removal PDF : 242KB | 18/02/2025 Quadrox Complete Pack, Membrane Perfusion Pack, Complete Neonatal Pack with HM, Miniaturised Neonatal Pack_Maquet Cardiopulmonary GmbH_Advice regarding a device removal PDF : 444KB | 18/02/2025 TEE Care System_S.I.D.EM. S.p.A_Advice regarding a device modification PDF : 437KB | 18/02/2025 Atellica CH UrinaryCerebrospinal Fluid Protein (UCFP)_Siemens Healthcare Diagnostics Inc_Advice regarding a device removal_FSN Update PDF : 209KB | 18/02/2025 Philips Azurion System_Philips Medical Systems Nederland BV_Advice regarding the use of the device PDF : 574KB | 18/02/2025 Atellica CH Urinary Cerebrospinal Fluid Protein(UCFP) ADVIA Chemistry Urinary Cerebrospinal Fluid Protein(UCFP)_Siemens Healthcare Diagnostics Inc_Advice regarding a device removal PDF : 213KB | 18/02/2025 Anaesthia systems_GE healthcare_Advice regarding the use of the device PDF : 169KB | 18/02/2025 WallFlex & Agile Esophageal Stent Systems_Boston Scientific Corporation, USA_Advice regarding a device removal PDF : 205KB | 18/02/2025 VKMO 70000 #SQUADROX-i HMO 70000 VHK7100_Maquet Cardiopulmonary GmbH_Advice regarding a device removal PDF : 277KB | 18/02/2025 Impella 5.5; Impella CP (with SmartAssist)_Abiomed Inc_Advice regarding the use of the device PDF : 530KB | 18/02/2025 Access HBc Ab Reagent_Beckman Coulter_Advice regarding a device removal PDF : 364KB | 18/02/2025 Atellica CH Microalbumin_2_Siemens Healthcare Diagnostics Inc_Advice regarding the use of the device PDF : 198KB | 18/02/2025 Alinity i HBsAg Controls, ARCHITECT HBsAg Controls_Abbott Ireland Diagnostics Division Sligo_Advice regarding a device removal PDF : 173KB | 18/02/2025 Fluido Trauma Fluido Standard set sterile_The Surgical Company International BV_Advice regarding the use of the device PDF : 272KB | 18/02/2025 Airvo 3_Fisher & Paykel Healthcare_Advice regarding a software upgrade PDF : 208KB | 18/02/2025 Atellica IM Anti-Thyroid Peroxidase (aTPO) Assay_Siemens Healthcare Diagnostics Inc_Advice regarding a device removal PDF : 291KB | 18/02/2025 Change Healthcare Cardiology HemoHemodynamics_Change Healthcare Canada Company_Advice regarding a software upgrade PDF : 405KB | 18/02/2025 Vercise Genus Implantable Pulse Generator System_Boston Scientific Limited_Advice regarding the use of the device PDF : 188KB | 18/02/2025 ERYTRA EFLEXIS_Diagnostic Grifols S.A._Advice regarding the use of the device PDF : 195KB | 18/02/2025 Biodesign Fistula Plug_Cook Biotech Inc. USA_Advice regarding a device removal PDF : 176KB | 18/02/2025 iBur Distal Bend Cutting Accessories_Stryker Instruments_Advice regarding a device removal PDF : 288KB | 18/02/2025 Airvo 3_Fisher & Paykel Healthcare_Advice regarding a software upgrade_HCP PDF : 166KB | 18/02/2025 UMIC Colistin_Bruker Daltonics GmbH & Co. KG_Advice regarding a device removal PDF : 219KB | 18/02/2025 Philips Allura Xper_Philips Medical Systems Nederland BV_Advice regarding the use of the device PDF : 216KB | 18/02/2025 High Flow Insufflation Unit (UHI-4)_Olympus Medical Systems Corporation_Advice regarding a software upgrade PDF : 220KB | 18/02/2025 Miami J Select cervical collar_Össur hf_Advice regarding a device removal PDF : 257KB | 18/02/2025 1.2 K-Draht, Lanzette, 150mm_Medartis AG, Switzerland_Advice regarding a device removal PDF : 131KB | 18/02/2025 DLP Single Stage Venous Cannulae_Medtronic Inc._Advice regarding a device removal PDF : 172KB | 18/02/2025 Braun Thermoscan Pro 6000_Welch Allyn, Inc._Advice regarding the use of the device_Updated FSN PDF : 289KB | 18/02/2025 Proteus XRa_GE Hualun Medical Systems Co. Ltd_Advice regarding changes or updates made to instructions for use PDF : 104KB | 18/02/2025 Centricity Universal Viewer Zero Footprint client_GE HealthCare_Advice regarding a software upgrade PDF : 150KB | 18/02/2025 Extremity drape_Mölnlycke Health Care AB_Advice regarding a device removal PDF : 79KB | 18/02/2025 Dailies Total1 & TOTAL30 soft contact lens_Alcon Laboratories_Advice regarding a device removal PDF : 118KB | 18/02/2025