Summary of Field Safety Notices February 2024

01/03/2024
Medical devices Summary of field safety notices (FSN)

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

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

Documents

Anti-k_DiaMed GmbH_Advice regarding the use of the device PDF : 273KB | 18/02/2025 ARCHITECT STAT Myoglobin Reagent Kit_Abbott Laboratories Diagnostics Division_Advice regarding a device removal PDF : 180KB | 18/02/2025 ACUSON Redwood ultrasound system_Siemens Medical Solutions USA, Inc. Ultrasound_Advice regarding the use of the device PDF : 167KB | 18/02/2025 ACUSON JuniperJuniper Select ultrasound system_Siemens Medical Solutions USA, Inc Ultrasound_Advice regarding the use of the device PDF : 167KB | 18/02/2025 Access Substrate_Beckman Coulter Diagnostics Limited_Advice regarding the use of the device PDF : 131KB | 18/02/2025 ACL TOP FAMILY 50 SERIES_Werfen_Advice regarding a software upgrade PDF : 152KB | 18/02/2025 TROJAN MAGNUM RIBBED 12CT_Pemberton Marketing International Limited_Advice regarding a device removal PDF : 109KB | 18/02/2025 Folding Walking Frame_IDENTITES 49_Advice regarding a device removal PDF : 913KB | 18/02/2025 Soltive™ SuperPulsed Laser System_Gyrus ACMI, Inc. (Olympus Surgical Technologies America)_Advice regarding the use of the device PDF : 91KB | 18/02/2025 Original Perfusor® Line_B.Braun Melsungen AG_Advice regarding a device removal PDF : 651KB | 18/02/2025 Orthopaedic bone screw, non-bioabsorbable, sterile_In2Bones SAS_Advice regarding a device removal PDF : 272KB | 18/02/2025 Trochanteric Fixation Nail - Advanced; 2.7mm VA LCP Clavicle Plates System; OPAL Intervertebral Cage_Synthes GmbH_Advice regarding a device removal PDF : 199KB | 18/02/2025 S-Dilator Set_Biorad Medysis PVT LTD_Advice regarding a device removal PDF : 774KB | 18/02/2025 Surgilon Braided Nylon Sofsilk Waxsilicone Coated Braided Silk, Ti-Cron Coated Braided Polyester, Monosof Monofilament Nylon Stainless Steel Suture Sutures_Covidien IIc_Advi PDF : 488KB | 18/02/2025 POLYPERF SAFE®_Vygon_Advice regarding a device removal PDF : 172KB | 18/02/2025 HeartSine samaritanPAD 350P360P450P500P_HeartSine Technologies Ltd(Stryker Medical)_Advice regarding a device removal PDF : 369KB | 18/02/2025 Philips Achieva, Ingenia CZ, Intera, SmartPath MR systems with 60cm wide bore_Philips Healthcare_Advice regarding a device modification PDF : 266KB | 18/02/2025 Medtronic NIM™ Standard Reinforced EMG Endotracheal Tube & NIM CONTACT Reinforced EMG Endotracheal Tube_Medtronic Xomed Inc._Advice regarding changesupdates made to instructions PDF : 187KB | 18/02/2025 MINC Benchtop Incubator_William A. Cook Australia Pty Ltd_Advice regarding a device modification PDF : 211KB | 18/02/2025 POLARSHEATH Steerable Sheath_Boston Scientific Corporation_Advice regarding a device removal PDF : 280KB | 18/02/2025 ExcelsiusGPS® Cannula A, 9mm x 250mm_Globus Medical_Advice regarding a device removal PDF : 535KB | 18/02/2025 BIOFIRE Pneumoniaplus (PNplus) Panel_BioFire Diagnostics, LLC_Advice regarding the use of the device PDF : 256KB | 18/02/2025 Duet External Drainage and Monitoring System_ Medtronic Inc._Advice regarding a device removal PDF : 229KB | 18/02/2025 FilmArray® Gastrointestinal (GI) Panel_BioFire Diagnostics, LLC_Advice regarding the use of the device PDF : 212KB | 18/02/2025 BD BodyGuard™ MicroSets_Caesarea Medical Electronics Limited_Advice regarding a device removal PDF : 393KB | 18/02/2025 fabian HFO fabian nCPAP evolution, and fabian Therapy evolution_Acutronic Medical Systems AG_Advice regarding changesupdates made to instructions for use_IFU Update PDF : 224KB | 18/02/2025 IH-500_DiaMed GmbH_Advice regarding the use of the device PDF : 442KB | 18/02/2025 paraPAC Plus™ ventilators_Smiths Medical_Advice regarding the use of the device PDF : 231KB | 18/02/2025 DLP™ Vessel Cannulae_Medtronic_Advice regarding a device removal PDF : 164KB | 18/02/2025 Ionolux_VOCO GmbH_Advice regarding a device removal PDF : 130KB | 18/02/2025 Kangaroo Enteral Feeding Pump Sets_Covidien llc_Advice regarding the use of the device PDF : 188KB | 18/02/2025 HeartMate II & HeartMate 3 LVAS Kits & Outflow Grafts_Thoratec Corporation_Advice regarding the use of the device PDF : 158KB | 18/02/2025 iSLEEVE™ Expandabel Introducer Set_Boston Scientific Corporation_Advice regarding a device removal PDF : 151KB | 18/02/2025 Kangaroo Enteral Feeding Pump Sets_Covidien llc_Advice regarding the use of the device_AttachmentA PDF : 154KB | 18/02/2025 Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, Vascular Probe Intravascular Probe, Ma Recette Mitonnee Leg MP 6_SYNOVIS LIFE TECHNOLOGIES INC._Advice PDF : 172KB | 18/02/2025 BIOFIRE BCID2 Panel_BioFire Diagnostics, LLC_Advice regarding the use of the device PDF : 247KB | 18/02/2025 DxA 500 Automation System DxA Aliquoter_Beckman Coulter Diagnostics Limited_Advice regarding the use of the device PDF : 114KB | 18/02/2025 fabian HFO fabian nCPAP evolution, and fabian Therapy evolution_Acutronic Medical Systems AG_Advice regarding changesupdates made to instructions for use PDF : 180KB | 18/02/2025 Care Plus Incubators Lullaby incubators_GE Healthcare_Advice regarding the use of the device PDF : 486KB | 18/02/2025 Dilators - Coons Taper; Entuit™ Secure Adjustable Gastrointestinal Suture Anchor Sets; Chiba Biopsy Needles _Cook Incorporated_Advice regarding a device removal PDF : 157KB | 18/02/2025 CU-SP1, CU-SP1 AUTO iPAD AEDs_CU Medical Systems, Inc._Advice regarding a device removal PDF : 688KB | 18/02/2025 CEREBASE DA Guide Sheath_Medos International SARL_Advice regarding a device removal PDF : 431KB | 18/02/2025 Atellica IM Cortisol and ADVIA Centaur Cortisol_Siemens Healthineers_Advice regarding the use of the device_FollowUpFSN PDF : 166KB | 18/02/2025