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09.07.2025
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Urgent Field Safety Notice for Carotid Wallstent Monorail by Boston Scientific Corporation Marlborough
Product group Non-active implants -
special implants
Reference 29555/25
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09.07.2025
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Urgent Field Safety Notice for UniCel DxI 800 Access Immunoassay-Analysegerät und weitee by Beckman Coulter
Product group In-vitro diagnostics -
equipment / products for clinical chemistry
Reference 29764/25
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09.07.2025
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Urgent Field Safety Notice for Philips Intera, Achieva, Ingenia CX by PHILIPS HEALTHCARE FRANCE
Product group Electromedical fields -
equipment for MR tomography
Reference 32635/23
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08.07.2025
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Urgent Field Safety Notice for Micro Joystick R-net, Multi Joystick R-net, All-round Joystick (Light) R-net, Heavy Duty Joystick R-net by mo-Vis bv
Product group Orthopaedic / Rehabilitation technology -
mobility aids
Reference 27077/25
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08.07.2025
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Urgent Field Safety Notice for Infinia and VG Series Nuclear Medicine systems by GE Medical Systems Israel, Functional Imaging
Product group Radiological technology -
equipment for nuclear medical functional and localisation diagnostics
Reference 28681/25
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08.07.2025
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Urgent Field Safety Notice for Q-Link 13, Adapter kit LikoScale, and LIKO UNO 102 EE Mobile lift by Liko AB
Product group General equipment for medical treatment -
ward equipment and equipment for emergency medical services
Reference 26673/25
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08.07.2025
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Urgent Field Safety Notice for lifecath CT PICC easy by VYGON GmbH & Co. KG
Product group Injections / Infusions / Transfusions / Dialysis -
catheters
Reference 29361/25
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|
08.07.2025
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Urgent Field Safety Notice for Nellcor Bedside SpO2 Monitor by Covidien llc
Product group Medical electronics / Electromedical devices -
electrodiagnostics
Reference 27511/25
|
|
08.07.2025
|
Urgent Field Safety Notice for Unity Femoral Sizer by Corin Medical Ltd.
Product group Medical instruments for use in humans -
bone surgery
Reference 29300/25
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|
08.07.2025
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Urgent Field Safety Notice for 3mensio Workstation by Pie Medical Imaging B.V.
Product group Medical data processing (software) -
software for computer-based treatment
Reference 28334/25
|
|
08.07.2025
|
Urgent Field Safety Notice for Achieva 3.0T/XR, Evolution upgrade 1.5T/3.0T, Ingenia 1.5T/1.5T S/3.0T/3.0T CX/Ambition S/Ambition X/Elition S/Elition X/Intera 3.0T Quasar Dual, MR 5300, MR 7700, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0 by Philips Medical Systems Nederland B.V.
Product group Electromedical fields -
equipment for MR tomography
Reference 28689/25
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|
08.07.2025
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Urgent Field Safety Notice for Heater Unit HU35 by Maquet Cardiopulmonary AG
Product group Surgical equipment/ Anaesthesia -
surgical equipment
Reference 10605/22
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|
04.07.2025
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Submission of Variations
Aerosol dispensers containing fluorinated greenhouse gases, including medicinal metered dose inhalers, may only be placed on the market, supplied or made available to third parties in the EU from 1 January 2025 if they are labelled in accordance with Article 12(3) of Regulation (EU) 2024/573 on fluorinated greenhouse gases (F-Gas Regulation).
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04.07.2025
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Proposal procedure to maintain OPS and ICD-10-GM
Proposal procedure for ICD-10-GM and OPS
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|
03.07.2025
|
Urgent Field Safety Notice for POLYCENTRIC 4 BAR MANUAL LOCKING KNEE by Regal Prosthesis Ltd
Product group Non-active implants -
bone surgery
Reference 27664/25
|
|
02.07.2025
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Urgent Field Safety Notice for BiPAP A40 Pro, BiPAP A40 EFL, BiPAP A30 EFL by Respironics, Inc. Pittsburgh
Product group Surgical equipment/ Anaesthesia -
anaesthesia and medical gas supply
Reference 20133/24
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|
02.07.2025
|
Urgent Field Safety Notice for SWISS optio regflow by Gebr. Gloor AG
Product group Surgical equipment/ Anaesthesia -
anaesthesia and medical gas supply
Reference 27126/25
|
|
02.07.2025
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Urgent Field Safety Notice for DxI 9000 Access Immunoassay Analyzer by Beckman Coulter Inc.
Product group In-vitro diagnostics -
equipment / products for clinical chemistry
Reference 25450/25
|
|
02.07.2025
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Urgent Field Safety Notice for Injection needle by Spiggle & Theis Medizintechnik GmbH
Product group Injections / Infusions / Transfusions / Dialysis -
syringes and cannulas
Reference 27934/25
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|
01.07.2025
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DRKS - List of all studies registered in 2025, as of 2025/06/30
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