Recall Europe Medical Device

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U.S. FDA classifies recall of Philips' respiratory devices as most ...

https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-classifies-recall-philips-respiratory-devices-most-serious-2023-02-16/

2 days ago · The U.S. Food and Drug Administration (FDA) on Thursday classified the recall of Dutch medical devices maker Philips' respiratory machines as most serious, saying their use could lead to injuries ...

Quality defects and recalls | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/post-authorisation/compliance/quality-defects-recalls

Rapid alerts and recalls. This content applies to human and veterinary medicines. The European Medicines Agency (EMA) coordinates the assessment of reports of product …

International Medical Devices Database

https://medicaldevices.icij.org/

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers. ... Implant Files is an …

Medical devices | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

The Regulations on Medical Devices (Regulation (EU) 2017/745) and on In Vitro Diagnostic Devices (Regulation (EU) 2017/746) changed the European legal …

Best Recall Practices Guidelines — Part 1 — Medical …

https://www.sidley.com/en/insights/publications/2021/02/best-recall-practices-guideline--part-1-medical-devices

Best Recall Practices Guidelines — Part 1 — Medical Devices. February 2021. In this first part of a short series of articles about the recall of products in the life sciences sector …

European medical device recalls increase by 11% - Sedgwick

https://www.sedgwick.com/news/2022/european-medical-device-recalls-increase-by-11

LONDON, 16 September 2022 – Sedgwick brand protection published their latest European product recall index report for Q2. Medical device recall increased to …

EU Medical Device Vigilance Reporting in Europe - Emergo

https://www.emergobyul.com/services/medical-device-vigilance-and-incident-reporting-europe

EU medical device adverse incident and FSCA reporting process. These are the basic steps to reporting an incident in Europe: Reference MEDDEV 2.12/1 to determine the …

Market surveillance and vigilance - Public Health

https://health.ec.europa.eu/medical-devices-sector/directives/market-surveillance-and-vigilance_en

Eudamed2 - European Databank on Medical Devices. Eudamed2 is the European Databank on Medical Devices. Its purpose is to strengthen market surveillance and …

Medical Device Product Recall per EU Requirements - Elsmar …

https://elsmar.com/elsmarqualityforum/threads/medical-device-product-recall-per-eu-requirements.62986/

EU Medical Device Regulations. 4. Dec 7, 2021. B. Acquired Medical Device Product Line - Documentation Requirements for Device Master Record. ISO …

GE HealthCare Recalls Nuclear Medicine 600/800 …

https://www.fda.gov/medical-devices/medical-device-recalls/ge-healthcare-recalls-nuclear-medicine-600800-series-systems-risk-detector-fall-may-injure-patients

See Medical Device Recall Database entry for more information. Distribution Dates: April 1, 2018 to December 16, 2022; Devices Recalled in the U.S.: 688; Date …

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