Guide To Recalls Of Medical Devices

Medical Device Recalls | FDA

https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls

If you wish to find information on a recall, or a correction or removal action that has not yet been classified, you can search the Medical Device Recalls Database. Please note that the FDA...

Recalls, Corrections and Removals (Devices) | FDA

https://www.fda.gov/medical-devices/postmarket-requirements-devices/recalls-corrections-and-removals-devices

What is a Medical Device Recall? | FDA

https://www.fda.gov/medical-devices/medical-device-recalls/what-medical-device-recall

Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. A medical device recall does not always …

Guide to Recall of Medical Devices (GUI-0054) - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/problem-reporting/medical-devices-recall-guide-0054.html

Use the Medical Device Recall Reporting Form - Final (FRM-0360) to complete your final recall report. Health Canada's Recall Policy (POL-0016) further …

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 …

GE HealthCare Recalls Nuclear Medicine Systems for …

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 …

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, …

Philips recalls certain reworked Trilogy, Garbin ventilators

https://www.massdevice.com/philips-recalls-reworked-trilogy-garbin-ventilators/

1 day ago · The FDA notice includes devices distributed between March 1, 2022, and Sept. 6, 2022. Devices recalled in the U.S. total 13,811 since Philips initiated the recall on Dec. …

Philips CPAP Recall: Related MDRs Top 98K, Including 346 Deaths

https://www.drugwatch.com/news/2023/02/16/philips-cpap-recall-deaths/

Between April 2021 and Dec. 31, 2022, there have reportedly been 346 deaths related to the medical devices. The MDRs include adverse effects reportedly …

RQM+ Quick Guide to Medical Device …

https://www.rqmplus.com/blog/rqm-quick-guide-to-medical-device-recall-management

What are some best practices for medical device recall management? Avoid a recall in the first place.. Implement a risk management system that is in compliance with ISO …