Summary of Field Safety Notices March 2024

01/04/2024
Medical devices Summary of field safety notices (FSN)

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

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

Documents

Cystatin C Calibrator (CYSC CAL)_Randox Laboratories Ltd._Advice regarding changesupdates made to instructions for use PDF : 5.11MB | 18/02/2025 HIGH FLOW INSUFFLATION UNIT_Olympus_Advice regarding the use of the device PDF : 208KB | 18/02/2025 EXPO™ 5F Angiographic Catheters_Boston Scientific Corporation_Advice regarding a device removal PDF : 183KB | 18/02/2025 EQUASHIELD® Closed System Transfer Device, Spike Tubing, Ref. SA-1E_EQUASHIELD Medical Ltd_Advice regarding a device modification PDF : 113KB | 18/02/2025 Dako CoverStainer and Dako CoverStainer Certified Pre-Owned_Agilent Technologies Inc._Advice regarding the use of the device PDF : 209KB | 18/02/2025 Covidien Auto Suture™ Structural Balloon Trocar & Auto Suture™ Blunt Tip Trocar_Covidien IIc_Advice regarding the use of the device PDF : 118KB | 18/02/2025 CarboFlex®_Convatec Ltd_Advice regarding a device removal PDF : 528KB | 18/02/2025 AltoSa-XL-Gemini Balloon Catheter_Andratec GmbH_Advice regarding a device removal PDF : 589KB | 18/02/2025 Liquid Protein Calibrators_Randox Laboratories Ltd_Advice regarding a device modification PDF : 4.34MB | 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 : 177KB | 18/02/2025 Cannulae_Medtronic Inc._Advice regarding a device removal PDF : 294KB | 18/02/2025 Cardiohelp-i_Maquet Cardiopulmonary GmbH_Advice regarding a device modification PDF : 569KB | 18/02/2025 Allurion Device Elipse Gastric Balloon System_Allurion_Advice regarding the use of the device PDF : 1.26MB | 18/02/2025 Celex, Intelli-C_NRT X-Ray AS_Advice regarding a device modification PDF : 50KB | 18/02/2025 NxTAG Respiratory Pathogen Panel & NxTAG Respiratory Pathogen Panel SARS-CoV-2_Luminex, A DiaSorin Company_Advice regarding the use of the device (2) PDF : 731KB | 18/02/2025 Calibration Serum Level 3_Randox Laboratories Ltd_Advice regarding the use of the device PDF : 243KB | 18/02/2025 Atellica CH Iron3_Siemens Healthcare Diagnostics Inc_Advice regarding the use of the device PDF : 229KB | 18/02/2025 1.2 K-Draht, Lanzette, 150mm_Medartis GmbH_Advice regarding a device removal PDF : 282KB | 18/02/2025 CADD-Solis™ Ambulatory Infusion Pumps_Smiths Medical_Advice regarding a software upgrade PDF : 255KB | 18/02/2025 Alinity m System_Abbott Molecular, Inc._Advice regarding the use of the device PDF : 115KB | 18/02/2025 TriLock Distal Radius Plates_Medartis AG_Advice regarding a device removal PDF : 205KB | 18/02/2025 SOFTWARE APP 9735762 STEALTH S8 APPLICATION_Medtronic Navigation, Inc._Advice regarding a software upgrade PDF : 141KB | 18/02/2025 NxTAG Respiratory Pathogen Panel & NxTAG Respiratory Pathogen Panel SARS-CoV-2_Luminex, A DiaSorin Company_Advice regarding the use of the device PDF : 730KB | 18/02/2025 Palindrome Precision H Chronic Catheter Kit 23 cm40 cm_Medtronic Limited_Advice regarding a device removal PDF : 217KB | 18/02/2025 Soltive™ SuperPulsed Laser System_Gyrus ACMI, Inc. (Olympus Surgical Technologies America)_Advice regarding a device removal PDF : 229KB | 18/02/2025 Trilogy Evo,Trilogy Evo O2,Trilogy EV300_Philips Respironics, Inc._Advice regarding the use of the device PDF : 186KB | 18/02/2025 Regulated Decision Support Framework_Epic Systems Corporation_Advice regarding a software upgrade PDF : 598KB | 18/02/2025 Vizulize Irritated Eye Mist & Pollenase Allergy Eye Mist_Advena Limited_Advice regarding a device removal PDF : 172KB | 18/02/2025 PERI-GUARD Repair Patch and SUPPLE PERI-GUARD Repair Patch_SYNOVIS LIFE TECHNOLOGIES, INC (SUBSIDIARY OF BAXTER INTERNATIONAL INC)_Advice regarding changesupdates made to instructi PDF : 204KB | 18/02/2025 Peri-Guard Repair Patch and Supple Peri-Guard Repair Patch_SYNOVIS LIFE TECHNOLOGIES, INC (SUBSIDIARY OF BAXTER INTERNATIONAL INC)_Advice regarding changesupdates made to instruction PDF : 124KB | 18/02/2025 SureForm4560, Cannula Seal, Arm Drape, Obturator_Intuitive Surgical, Inc._Advice regarding a device removal PDF : 234KB | 18/02/2025 Perseus A500_Drägerwerk AG & Co. KGaA_Advice regarding the use of the device PDF : 189KB | 18/02/2025 HLS Set_Maquet Cardiopulmonary GmbH_Advice regarding the use of the device PDF : 1.28MB | 18/02/2025 MAQUET SAS_Maquet SAS’ OR Light Systems_Advice regarding changesupdates made to instructions for use PDF : 788KB | 18/02/2025 Hugo™ RAS Tower_Covidien llc_Advice regarding the use of the device PDF : 128KB | 18/02/2025 Hugo™ RAS Surgeon Console_Covidien llc_Advice regarding the use of the device PDF : 109KB | 18/02/2025 Impella CP, Impella 5.5, Impella RP, Impella 5.0_Abiomed Inc._Advice regarding the use of the device PDF : 183KB | 18/02/2025