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04.12.2025 Urgent Field Safety Notice for UniCel DxI 600; UniCel DxI 800 by Beckman Coulter, Inc.

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 57272/25

03.12.2025 Proposal procedure to maintain OPS and ICD-10-GM

Proposal procedure for ICD-10-GM and OPS
03.12.2025 A fast-track approach for the authorization of multinational clinical trials in the EU/EEA will be launched as test

On November 27, 2025, European regulators and ethics committees agreed to pilot FAST‑EU, a new fast‑track approach for authorizing multinational clinical trials. Launching in January 2026, this initiative aims to deliver quicker, more predictable approvals while upholding Europe’s high scientific, ethical, and safety standards.
03.12.2025 Urgent Field Safety Notice for Otesus by Maquet GmbH

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 56118/25

03.12.2025 Urgent Field Safety Notice for LISA NE by FreiStil Tischlerei GmbH & Co. KG

Product group General equipment for medical treatment - furnishings
Reference 56069/25

03.12.2025 Urgent Field Safety Notice for CleanCell M by Roche Diagnostics GmbH

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 55975/25

03.12.2025 Urgent Field Safety Notice for Kendall SCD 700 Sequential Compression System by Cardinal Health 200, LLC

Product group Orthopaedic / Rehabilitation technology - orthoses
Reference 50474/25

02.12.2025 Urgent Field Safety Notice for FreeStyle Libre 3 and 3 Plus Sensor by Abbott Diabetes Care Ltd. UK

Product group Medical electronics / Electromedical devices - electric blood glucose meters
Reference 55464/25

01.12.2025 Analyse/Research

Analyse/Research
01.12.2025 Urgent Field Safety Notice for Intracranial Pressure Monitor Pressio®2 by Sophysa France

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 54884/25

01.12.2025 Urgent Field Safety Notice for Vue PACS (Diagnostic) V12, Vue Motion V12 by Philips Medical Systems Nederland B.V.

Product group Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine
Reference 56682/25

01.12.2025 Urgent Field Safety Notice for Carescape One by GE Medical Systems Information Technologies, Inc.

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 56465/25

01.12.2025 Urgent Field Safety Notice for ViewPoint 6 by GE Healthcare GmbH München

Product group Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine
Reference 56691/25

01.12.2025 Urgent Field Safety Notice for B125P/B105P/B125M/B105M/B155M Patient Monitor und Portrait VSM by GE Medical Systems Information Technologies, Inc.

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 56468/25

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

01.12.2025 Urgent Field Safety Notice for PALAMIX uno by Heraeus Medical GmbH

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 56642/25

01.12.2025 Downloads Iris Institute - Terms and conditions for downloading (PDF, 244 kB)

Downloads Iris Institute - Terms and conditions for downloading
28.11.2025 Urgent Field Safety Notice for Cardiosave Intraaortic Balloon Pump by Datascope Corp., Interventional Products Division

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 52623/25

28.11.2025 Urgent Field Safety Notice for Carescape B450 by GE Healthcare Finland Oy

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 56464/25

28.11.2025 Urgent Field Safety Notice for Cardiosave Intraaortic Balloon Pump by Datascope Corp., Interventional Products Division

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 52776/25