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10.09.2025
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Direct Healthcare Professional Communication (DHPC) on Isozid 0.5 N powder for solution for infusion: Visual particles, use of a particle filter
Active substance: isoniazid
Esteve Pharmaceuticals GmbH has issued a warning about visible particles in batch 286490A of the medicinal product Isozid 0.5 N powder for solution for infusion after reconstitution.
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09.09.2025
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Urgent Field Safety Notice for SenTiva Generator Model 1000 by LivaNova, Inc
Product group Active implantable medical devices -
biostimulators
Reference 42764/25
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09.09.2025
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Urgent Field Safety Notice for Kapillardrain by Primed Halberstadt Medizintechnik GmbH
Product group Injections / Infusions / Transfusions / Dialysis -
drainages and suction systems
Reference 42682/25
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09.09.2025
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Urgent Field Safety Notice for Blueflow Venous Stent by Contract Medical International GmbH
Product group Non-active implants -
special implants
Reference 39103/25
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08.09.2025
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Direct Healthcare Professional Communication (DHPC) on Clozapine: Revised recommendations for routine blood count monitoring with regard to the risk of agranulocytosis
Active substance: clozapine
The marketing authorisation holders of clozapine-containing medicinal products provide information on the revised recommendations for routine blood count monitoring.
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08.09.2025
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Urgent Field Safety Notice for VITROS Chemistry Products LAC Slides by Ortho-Clinical Diagnostics, Inc.
Product group In-vitro diagnostics -
equipment / products for clinical chemistry
Reference 36571/25
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08.09.2025
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Urgent Field Safety Notice for Philips Allura Xper, Allura Centron, Allura CV20 by Philips Nordic
Product group Radiological technology -
radiological equipment for vascular diagnostics
Reference 42563/25
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08.09.2025
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Urgent Field Safety Notice for Fujifilm FDR Visionary Suite by Shimadzu Corporation
Product group Radiological technology -
stationary radiological equipment
Reference 41141/25
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08.09.2025
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Urgent Field Safety Notice for ACCOLADE, ACCOLADE MRI; ALTRUA; PROPONENT, PROPONENT MRI; ESSENTIO, ESSENTIO MRI; VISIONIST X4; VALITUDE X4 by Boston Scientific CRM
Product group Active implantable medical devices -
cardiac pacemakers
Reference 43752/24
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08.09.2025
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Urgent Field Safety Notice for Liver Assist Perfusion Set by XVIVO B.V.
Product group Surgical equipment/ Anaesthesia -
surgical equipment
Reference 41271/25
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08.09.2025
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Urgent Field Safety Notice for Indiko (ISE), Indiko Plus (ISE) by Thermo Fisher Scientific Oy
Product group In-vitro diagnostics -
equipment / products for clinical chemistry
Reference 42064/25
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08.09.2025
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Urgent Field Safety Notice for Defigard HD-7 by Schiller Medical SAS
Product group Medical electronics / Electromedical devices -
electrotherapy
Reference 42108/25
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05.09.2025
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Levamisole: Review of the risk of leukoencephalopathy
Active substance: levamisole
The European Medicines Agency (EMA) is initiating a safety review of medicines containing levamisole for the treatment of parasitic worm infections.
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05.09.2025
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Urgent Field Safety Notice for StimuLong Sono II NanoLine by PAJUNK GmbH Medizintechnologie
Product group Injections / Infusions / Transfusions / Dialysis -
injection kits
Reference 42292/25
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04.09.2025
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Urgent Field Safety Notice for Automated Impella Controller by ABIOMED Inc.
Product group Medical electronics / Electromedical devices -
electrotherapy
Reference 40098/25
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04.09.2025
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Urgent Field Safety Notice for ATELLICA CH / ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP) by Siemens Healthcare Diagnostics Inc. Tarrytown
Product group In-vitro diagnostics -
equipment / products for clinical chemistry
Reference 41837/25
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04.09.2025
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Urgent Field Safety Notice for MEDILOOPS by Neuromedex GmbH
Product group Dressings / Pads -
surgical sutures, vascular loops etc.
Reference 41843/25
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04.09.2025
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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
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03.09.2025
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Urgent Field Safety Notice for Dexcom G6 CGM System by Dexcom, Inc
Product group Medical electronics / Electromedical devices -
electric blood glucose meters
Reference 38781/25
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03.09.2025
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Urgent Field Safety Notice for Blue sail EndoBule Endoscopic Stapler I by Changzhou Tongchuang Medical Instrument Technology Co. Ltd.
Product group Medical instruments for use in humans -
general instruments
Reference 40208/25
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