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12.09.2025
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Urgent Field Safety Notice for RENZAN by MicroVention,INC.
Product group Non-active implants -
special implants
Reference 43167/25
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11.09.2025
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Urgent Field Safety Notice for Allura Xper, Allura CV20 by Philips Nordic
Product group Radiological technology -
radiological equipment for vascular diagnostics
Reference 42673/25
|
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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
|
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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
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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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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
|
|
09.09.2025
|
Urgent Field Safety Notice for Kapillardrain by Primed Halberstadt Medizintechnik GmbH
Product group Injections / Infusions / Transfusions / Dialysis -
drainages and suction systems
Reference 42682/25
|
|
09.09.2025
|
Urgent Field Safety Notice for Blueflow Venous Stent by Contract Medical International GmbH
Product group Non-active implants -
special implants
Reference 39103/25
|
|
08.09.2025
|
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
|
|
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
|
|
08.09.2025
|
Urgent Field Safety Notice for Fujifilm FDR Visionary Suite by Shimadzu Corporation
Product group Radiological technology -
stationary radiological equipment
Reference 41141/25
|
|
08.09.2025
|
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
|
|
08.09.2025
|
Urgent Field Safety Notice for Liver Assist Perfusion Set by XVIVO B.V.
Product group Surgical equipment/ Anaesthesia -
surgical equipment
Reference 41271/25
|
|
08.09.2025
|
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
|
|
08.09.2025
|
Urgent Field Safety Notice for Defigard HD-7 by Schiller Medical SAS
Product group Medical electronics / Electromedical devices -
electrotherapy
Reference 42108/25
|
|
05.09.2025
|
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
|
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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