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14.10.2025
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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
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14.10.2025
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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
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13.10.2025
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Urgent Field Safety Notice for Citra-Lock S 4% by Sterisets Medical Products
Product group Injections / Infusions / Transfusions / Dialysis -
infusion technology
Reference 33610/25
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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
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13.10.2025
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Urgent Field Safety Notice for Eterna SCS IPG by Abbott - Neuromodulation Division
Product group Active implantable medical devices -
biostimulators
Reference 48274/25
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13.10.2025
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Urgent Field Safety Notice for Incisive CT, CT 5300 by Philips Healthcare (Suzhou) Co.,Ltd
Product group Radiological technology -
CT scanners
Reference 46209/25
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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
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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
|
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13.10.2025
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Urgent Field Safety Notice for EVIS EXERA III COLONOVIDEOSCOPE by Olympus Medical Systems Corp.
Product group Optics / Precision engineering -
endoscopes
Reference 47215/25
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09.10.2025
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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
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09.10.2025
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Urgent Field Safety Notice for Aeson Total Artificial Heart by CARMAT SA
Product group Active implantable medical devices -
artificial hearts
Reference 47997/25
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08.10.2025
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Urgent Field Safety Notice for Azurion by Philips Medical Systems Nederland B.V.
Product group Radiological technology -
radiological equipment for vascular diagnostics
Reference 26421/24
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08.10.2025
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Urgent Field Safety Notice for Spectra Optia BMP Set by Terumo BCT, Inc
Product group Medical instruments for use in humans -
bone surgery
Reference 46956/25
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08.10.2025
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Urgent Field Safety Notice for CD4 easy count kit, CD4% easy count kit by Sysmex Partec GmbH
Product group In-vitro diagnostics -
immunological products
Reference 46265/25
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08.10.2025
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Variation submission
Information on the change of marketing authorisation holder were added.
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07.10.2025
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Urgent Field Safety Notice for Signia Small Diameter Curved Tip Intelligent Reloads by Covidien llc
Product group Medical instruments for use in humans -
general instruments
Reference 46212/25
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07.10.2025
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Urgent Field Safety Notice for DxI 9000 Access Immunoassay Analyzer, DxC 500i by Beckman Coulter, Inc.
Product group In-vitro diagnostics -
equipment / products for clinical chemistry
Reference 46254/25
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07.10.2025
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Urgent Field Safety Notice for MEDAP TWISTA S. 1070, MEDAP BORA UP 2080, MEDAP VENTA S. 26 N, ATMOS Varioair 3 by ATMOS MedizinTechnik GmbH & Co. KG
Product group Surgical equipment/ Anaesthesia -
surgical equipment
Reference 46806/25
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07.10.2025
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Urgent Field Safety Notice for VITUS-Fi Distal Fibula Nail Ø 3.6mm, L 145mm by Dieter Marquardt-Medizintechnik GmbH
Product group Non-active implants -
bone surgery
Reference 47243/25
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