Medical Device Software Recalls

Medical Device Recalls | FDA

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

Summaries of information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that they could cause serious health problems or death.

Recalls, Corrections and Removals (Devices) | FDA

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

2022 Medical Device Recalls | FDA

https://www.fda.gov/medical-devices/medical-device-recalls/2022-medical-device-recalls

11/01/22. Philips Respironics Recalls Certain Masks for BiPAP, CPAP Machines Due to Safety Issue with Magnets That May Affect Certain Medical Devices. 10/18/22. Jiangsu …

Medical Device Recalls - Food and Drug Administration

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm

2021 Medical Device Recalls | FDA

https://www.fda.gov/medical-devices/medical-device-recalls/2021-medical-device-recalls

Dec 16, 2021

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 …

Software is a top cause of medical device recalls: Here's …

https://www.medicaldesignandoutsourcing.com/software-leading-cause-medical-device-recalls/

More than a quarter (25.7%) of all medical device recalls in Q4 2017 were due to software issues, making it the top cause for the seventh consecutive quarter. ...

Medical device recalls hit two-year high in Q2, report finds

https://www.medtechdive.com/news/device-recalls-two-year-high-q2-sedgwick/629979/

Sarah Silbiger via Getty Images. Medical device recalls reached their highest point over the last two years in the second quarter with safety and software …

Software-Related Recalls of Health Information …

https://pubmed.ncbi.nlm.nih.gov/28895231/

Software problems in medical devices are not rare and have the potential to negatively influence medical care. Premarket regulation has not captured all the software issues …

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, …