28.08.2025
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Urgent Field Safety Notice for Troponin I Test (Triage) by Quidel Corporation
Product group In-vitro diagnostics -
immunological products
Reference 40851/25
|
28.08.2025
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Urgent Field Safety Notice for CADD Medication Cassette Reservoir by ICU Medical Inc
Product group Injections / Infusions / Transfusions / Dialysis -
infusion technology
Reference 40521/25
|
28.08.2025
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Urgent Field Safety Notice for ARGUS PB-3000 by Schiller AG
Product group Medical electronics / Electromedical devices -
electrodiagnostics
Reference 37479/25
|
27.08.2025
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Urgent Field Safety Notice for ICEfx Cryoablation System by Boston Scientific Corporation Marlborough
Product group Surgical equipment/ Anaesthesia -
surgical equipment
Reference 39061/25
|
27.08.2025
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Urgent Field Safety Notice for Tentos 4F by optimed Medizinische Instrumente GmbH
Product group Injections / Infusions / Transfusions / Dialysis -
catheters
Reference 39287/25
|
26.08.2025
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Urgent Field Safety Notice for Alcon Standalone Vitrectomy Consumables by Alcon Laboratories, Inc.
Product group ophthalmological technology -
equipment for ophthalmological therapeutics
Reference 38501/25
|
26.08.2025
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Urgent Field Safety Notice for Heartstring III (Proximales Versiegelungssystem; HST III System) by Maquet Cardiovascular LLC
Product group Medical instruments for use in humans -
vascular surgery
Reference 40312/25
|
26.08.2025
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Urgent Field Safety Notice for MEDRAD Centargo by Imaxeon Pty Ltd Imaxeon is a subsidiary company of Bayer
Product group Injections / Infusions / Transfusions / Dialysis -
infusion technology
Reference 43923/24
|
25.08.2025
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Urgent Field Safety Notice for GORE ACUSEAL Vascular Graft by W. L. Gore & Associates, Inc.
Product group Non-active implants -
special implants
Reference 39840/25
|
25.08.2025
|
Pharmacoepidemiology
Pharmacoepidemiology
|
22.08.2025
|
Urgent Field Safety Notice for VITROS Chemistry Products Performance Verifier I & II by QuidelOrtho (Ortho Clinical Diagnostics Inc)
Product group In-vitro diagnostics -
equipment / products for clinical chemistry
Reference 27854/25
|
22.08.2025
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Urgent Field Safety Notice for Op-Air One TIIR by MEDICOM SAS
Product group General equipment for medical treatment -
auxiliary equipment
Reference 38680/25
|
22.08.2025
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Urgent Field Safety Notice for ViziShot 2 Flex by Gyrus ACMI Inc.
Product group Optics / Precision engineering -
endoscopes
Reference 37682/25
|
22.08.2025
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Direct Healthcare Professional Communication (DHPC) on Amversio 1 g powder for oral administration: wrong PZN encoded in the 2D barcode
Active substance: betaine
SERB Pharmaceuticals has reported that three batches were packaged for the German market with a faulty PZN number in the NTIN-DE and in the 2D barcode.
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21.08.2025
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Urgent Field Safety Notice for DLP Left Heart Vent Catheter by Medtronic Inc
Product group Injections / Infusions / Transfusions / Dialysis -
catheters
Reference 39581/25
|
21.08.2025
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Urgent Field Safety Notice for Versius Surgeon Console by CMR Surgical Ltd
Product group Surgical equipment/ Anaesthesia -
surgical equipment
Reference 38141/25
|
21.08.2025
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Urgent Field Safety Notice for Enterprise Archive by GE Healthcare
Product group Radiological technology -
auxiliary equipment and supplies for radiology / nuclear medicine
Reference 39630/25
|
21.08.2025
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Urgent Field Safety Notice for Exactech Equinoxe Humeral Liners by EXACTECH, Inc.
Product group Non-active implants -
bone surgery
Reference 39736/25
|
21.08.2025
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Urgent Field Safety Notice for Brilliance, Ingenuity and IQon CT systems by Philips Medical Systems Nederland B.V.
Product group Radiological technology -
CT scanners
Reference 39588/25
|
21.08.2025
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Direct Healthcare Professional Communication (DHPC) on Evrysdi 0,75 mg/ml powder for oral solution: Omission of mandatory labelling statement
Active substance: Risdiplam
The marketing authorization holder Roche Registration GmbH informs about the omission of a mandatory labelling statement on the bottle labels, product carton, summary of product characteristics and Instruction for
Constitution.
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