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15.10.2025
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Urgent Field Safety Notice for Zenition 50, Zenition 70 Systems by Philips Medical Systems Nederland B.V
Product group Radiological technology -
mobile radiological diagnostic facilities
Reference 47211/25
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15.10.2025
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Urgent Field Safety Notice for HeartWare Ventricular Assist System by Heartware, Inc.
Product group Active implantable medical devices -
artificial hearts
Reference 21994/20
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15.10.2025
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Urgent Field Safety Notice for Magnet Venting Path of 3 Tesla MRI System by Siemens Shenzhen Magnetic Resonance Ltd.
Product group Electromedical fields -
equipment for MR tomography
Reference 38389/25
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14.10.2025
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Urgent Field Safety Notice for MRI System by Siemens Healthcare GmbH - Diagnostic Imaging
Product group Electromedical fields -
equipment for MR tomography
Reference 37815/25
|
|
14.10.2025
|
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 48364/25
|
|
14.10.2025
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Urgent Field Safety Notice for Salem Sump Stomach Tubes with Anti-Reflux Valve by Cardinal Health 200, LLC
Product group Injections / Infusions / Transfusions / Dialysis -
probes
Reference 48122/25
|
|
14.10.2025
|
Urgent Field Safety Notice for CADD-Solis Ambulatory Infusion Pump by Smiths Medical ASD, Inc.
Product group Injections / Infusions / Transfusions / Dialysis -
infusion technology
Reference 48945/25
|
|
14.10.2025
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Urgent Field Safety Notice for BD Alaris System Infusion Pump by BD Switzerland Sarl
Product group Injections / Infusions / Transfusions / Dialysis -
infusion technology
Reference 48593/25
|
|
14.10.2025
|
Urgent Field Safety Notice for Linearity Test Kit by EKF-diagnostic GmbH
Product group In-vitro diagnostics -
equipment / products for clinical chemistry
Reference 48766/25
|
|
13.10.2025
|
Urgent Field Safety Notice for Citra-Lock S 4% by Sterisets Medical Products
Product group Injections / Infusions / Transfusions / Dialysis -
infusion technology
Reference 33610/25
|
|
13.10.2025
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Urgent Field Safety Notice for Procalcitonin FS by DiaSys Diagnostic Systems GmbH
Product group In-vitro diagnostics -
immunological products
Reference 48779/25
|
|
13.10.2025
|
Urgent Field Safety Notice for Eterna SCS IPG by Abbott - Neuromodulation Division
Product group Active implantable medical devices -
biostimulators
Reference 48274/25
|
|
13.10.2025
|
Urgent Field Safety Notice for Incisive CT, CT 5300 by Philips Healthcare (Suzhou) Co.,Ltd
Product group Radiological technology -
CT scanners
Reference 46209/25
|
|
13.10.2025
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Urgent Field Safety Notice for BD BACTEC Blood Culture System, BD Phoenix M50 Automated Microbiology System, BD MAX System, BD COR System, BD EpiCenter Microbiology Data Management System & BD Synapsys Informatics Solution by Becton, Dickinson and Company
Product group In-vitro diagnostics -
equipment / products for clinical chemistry
Reference 38239/24
|
|
13.10.2025
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Urgent Field Safety Notice for Automated Impella Controller by ABIOMED Inc.
Product group Medical electronics / Electromedical devices -
electrotherapy
Reference 46240/25
|
|
13.10.2025
|
Urgent Field Safety Notice for EVIS EXERA III COLONOVIDEOSCOPE by Olympus Medical Systems Corp.
Product group Optics / Precision engineering -
endoscopes
Reference 47215/25
|
|
09.10.2025
|
Direct Healthcare Professional Communication (DHPC) on caspofungin: Avoid use of polyacrylonitrile membranes during continuous renal replacement therapy.
Active substance: caspofungin
The marketing authorisation holders of caspofungin containing medicines would like to inform that during treatment with caspofungin the use of polyacrylonitrile membranes during continuous renal replacement therapy should be avoided.
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09.10.2025
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Urgent Field Safety Notice for ello 2.0 by VOSS healthcare GmbH
Product group Orthopaedic / Rehabilitation technology -
daily living aids
Reference 47553/25
|
|
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
|
|
09.10.2025
|
Variations
Information on the change of marketing authorisation holder were added.
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