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Date Title:
20.11.2025 Urgent Field Safety Notice for Anti-GBM by Orgentec Diagnostika GmbH

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 53627/25

11.11.2025 Urgent Field Safety Notice for AMNIOQUICK CARD (Ref 1090005) AMNIOQUICK CARD BSX (Ref 1090005_BSX) AMNIOQUICK DUO+ (Ref 1090004) AMNIOQUICK DUO+ BSX (Ref 1090004_BSX) by BIOSYNEX SA

Product group In-vitro diagnostics - immunological products
Reference 53415/25

01.12.2025 Urgent Field Safety Notice for Ambulatory Elastomeric Infusion Pumps by Baxter Healthcare S. (Opfikon)

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 56549/25

10.07.2025 Urgent Field Safety Notice for Ambu SPUR II by AMBU A/S

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 28516/25

11.11.2025 Urgent Field Safety Notice for Ambu SPUR II by AMBU A/S

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 48596/25

29.10.2025 Urgent Field Safety Notice for Altair Lifting Solutions by Human Care HC AB

Product group General equipment for medical treatment - ward equipment and equipment for emergency medical services
Reference 50196/25

11.09.2025 Urgent Field Safety Notice for Allura Xper, Allura CV20 by Philips Nordic

Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 42673/25

07.08.2025 Urgent Field Safety Notice for Allura Xper by Philips Medical Systems Nederland B.V.

Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 36163/25

04.09.2025 Urgent Field Safety Notice for AlloSeq cfDNA Software IFU by CareDx Pty Ltd

Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 37399/25

02.10.2025 Urgent Field Safety Notice for Alinity hq Analyzer by Abbott GmbH

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 45652/25

04.12.2025 Urgent Field Safety Notice for Alinity ci-series System Control Module (SCM) by Abbott GmbH

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 54741/25

26.08.2025 Urgent Field Safety Notice for Alcon Standalone Vitrectomy Consumables by Alcon Laboratories, Inc.

Product group ophthalmological technology - equipment for ophthalmological therapeutics
Reference 38501/25

18.09.2025 Urgent Field Safety Notice for AIRVO2 Humidifier / myAIRVO2 Humidifier by Fisher & Paykel Healthcare Ltd

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 43871/25

07.08.2025 Urgent Field Safety Notice for Agilia Connect VP by Fresenius Kabi AG

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 32960/25

01.08.2025 Urgent Field Safety Notice for Aeson Total Artificial Heart by CARMAT SA

Product group Active implantable medical devices - artificial hearts
Reference 23743/25

09.10.2025 Urgent Field Safety Notice for Aeson Total Artificial Heart by CARMAT SA

Product group Active implantable medical devices - artificial hearts
Reference 47997/25

02.09.2025 Urgent Field Safety Notice for AeroWalk Carbon Rollator by Drive Medical GmbH & Co. KG

Product group Orthopaedic / Rehabilitation technology - daily living aids
Reference 40093/25

19.08.2025 Urgent Field Safety Notice for AEROpart - Aerosol-Set 11-E, Aerosol-Inhalationsset, Erwachsene und Kinder, mit Aerosolmaske, Standard Medikamenten-Vernebler und Sauerstoff-Sicherheitsschlauch 2 m Inhalt des Verneblers: 6 ml by Jiangsu Weikang Jiejing Medical Apparatus Co.

Product group Physical therapy - inhalation therapy
Reference 23751/25

01.07.2025 Urgent Field Safety Notice for ACL TOP 970 CL by Instrumentation Laboratory Co.

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 27696/25

08.07.2025 Urgent Field Safety Notice for Achieva 3.0T/XR, Evolution upgrade 1.5T/3.0T, Ingenia 1.5T/1.5T S/3.0T/3.0T CX/Ambition S/Ambition X/Elition S/Elition X/Intera 3.0T Quasar Dual, MR 5300, MR 7700, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0 by Philips Medical Systems Nederland B.V.

Product group Electromedical fields - equipment for MR tomography
Reference 28689/25