Software Related Medical Device 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.

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

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

Five years ago the largest medical device recall was nearly twice the size of that in 2017, caused by a single sterility-compromised product that resulted in 102 million …

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

Software-Related Recalls of Health Information …

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

Provisions of the 21st Century Cures Act that became law in late 2016 will reduce safeguards further. Absent stronger regulations and implementation to create robust risk …

Software‐Related Recalls of Health Information …

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5594275/

Unfortunately, there is currently very little published information available that describes the impact of health IT and other types of software on patient safety.11 Earlier …

Software-Related Recalls of Health Information …

https://www.milbank.org/quarterly/articles/software-related-recalls-health-information-technology-medical-devices-implications-fda-regulation-digital-health/

Medical software has become an increasingly critical component of health care, yet the regulatory landscape for digital health is inconsistent and controversial. Researchers used FDA databases to …

Study of Software-Related Causes in the FDA Medical …

https://experts.illinois.edu/en/publications/study-of-software-related-causes-in-the-fda-medical-device-recall

Collecting all software-related medical device recalls is an effort that needs the support and contributions from a large research, industrial, and medical community, To facility …

Medical device recalls due to software …

https://www.statista.com/statistics/618218/medical-device-software-related-recalls/

This statistic shows the number of medical devices recalled due to software issues in the U.S. from 2010 to 2018. In 2015, there were 243 such recalls reported in 2015. However, during …

5 Staggering Medical Device Recall …

https://www.qualio.com/blog/medical-device-recall-statistics

1. Recalls Jumped 71% in 2018 and 2019 vs. the Previous Two Years. 409.5 million medical device units were recalled in 2016-2017, averaging 58.19 million units per quarter. In 2018 and …