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18.09.2025
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Urgent Field Safety Notice for MADSEN AccuScreen TEAOE/DPOAE/ABR Probe by PATH MEDICAL GmbH
Product group Medical electronics / Electromedical devices -
ENT equipment
Reference 43282/25
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18.09.2025
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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
|
|
18.09.2025
|
Urgent Field Safety Notice for TactiFlex Force Sensing Ablation Catheter, S. by Abbott Plymouth, Product Performance Group
Product group Injections / Infusions / Transfusions / Dialysis -
catheters
Reference 43964/25
|
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18.09.2025
|
Urgent Field Safety Notice for Inogen Rove 4 Portable Oxygen Concentrator by Inogen, Inc.
Product group Physical therapy -
equipment for oxygen therapy
Reference 44123/25
|
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18.09.2025
|
Urgent Field Safety Notice for Catalyft PL Expandable Interbody System by Medtronic Sofamor Danek Inc.
Product group Non-active implants -
bone surgery
Reference 44690/25
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18.09.2025
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Urgent Field Safety Notice for BRONCHOVIDEOSCOPE and BRONCHOFIBERSCOPE, divers by Olympus Medical Systems Corp.
Product group Optics / Precision engineering -
endoscopes
Reference 42982/25
|
|
16.09.2025
|
Finasteride- and dutasteride-containing medicines: Suicidal thoughts and behaviours
Active substance: finasteride, dutasteride
The Federal Institute for Drugs and Medical Devices (BfArM) implements the final decision of the EU Commission nationally.
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|
16.09.2025
|
Urgent Field Safety Notice for Heater Unit HU35 by Maquet Cardiopulmonary AG
Product group Surgical equipment/ Anaesthesia -
surgical equipment
Reference 43846/25
|
|
16.09.2025
|
Urgent Field Safety Notice for Sharesource Claria Connectivity Platform (Product Code 5CGM01 by Baxter Healthcare S. (Opfikon)
Product group Injections / Infusions / Transfusions / Dialysis -
dialysis technology
Reference 41831/25
|
|
15.09.2025
|
Urgent Field Safety Notice for FreeStyle Libre 3 Plus by Abbott Diabetes Care Ltd. UK
Product group Medical electronics / Electromedical devices -
electric blood glucose meters
Reference 42777/25
|
|
15.09.2025
|
Direct Healthcare Professional Communication (DHPC) on finasteride und dutasteride: New measures to minimise the risk of suicidal thoughts
Active substance: finasteride, dutasteride
The marketing authorisation holders of finasteride- and dutasteride-containing medicinal products provide information on suicidal thoughts as an adverse drug reaction of orally administered finasteride-containing products.
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|
12.09.2025
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Azithromycin: Re-evaluation of the benefits and risks
Active substance: azithromycin
The European Commission's final decision on the risk assessment procedure for azithromycin has been published.
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|
12.09.2025
|
Urgent Field Safety Notice for MassCheck Dried Blood Spot Control Bi-Level I+II by Chromsystems Instruments & Chemicals GmbH
Product group In-vitro diagnostics -
equipment / products for clinical chemistry
Reference 43400/25
|
|
12.09.2025
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Urgent Field Safety Notice for Charging unit mounted W/T AC TS7500 by Baxter Medical Systems GmbH + Co. KG
Product group Surgical equipment/ Anaesthesia -
surgical equipment
Reference 42068/25
|
|
12.09.2025
|
Urgent Field Safety Notice for STA LIATEST DDI PLUS (IVDR Class C) by Diagnostica Stago
Product group In-vitro diagnostics -
haematological, histological and cytological products
Reference 42894/25
|
|
12.09.2025
|
Urgent Field Safety Notice for RENZAN by MicroVention,INC.
Product group Non-active implants -
special implants
Reference 43167/25
|
|
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
|
|
10.09.2025
|
Urgent Field Safety Notice for Getinge 88-series by Getinge Disinfection AB
Product group General equipment for medical treatment -
cleaning / disinfection / sterilisation
Reference 39788/25
|
|
10.09.2025
|
Urgent Field Safety Notice for Evolution Upgrade 1.5T, 3.0T; Ingenia 1.5T, 1.5T CX, 1.5T S. 3.0T, 3.0T CX, Ambition S. Ambition X, Elition S. Elition X; MR 5300, MR 7700; SmartPath to dStream for 1.5T, 3.0T, XR and 3.0T, Ingenia Elition X; Upgrade to MR 7700 by Philips Medical Systems Nederland B.V.
Product group Electromedical fields -
equipment for MR tomography
Reference 19824/25
|
|
10.09.2025
|
Urgent Field Safety Notice for FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26 by Agilent Technologies Singapore
Product group In-vitro diagnostics -
immunological products
Reference 37144/25
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