Analysis And Classification Of Medical Device Recalls

Analysis and Classification of Medical Device Recalls

https://link.springer.com/chapter/10.1007/978-3-540-36841-0_957

Medical Device Recalls | FDA

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

The FDA posts summaries of information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that …

Recalls, Corrections and Removals (Devices) | FDA

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

Medical Device Recalls - Food and Drug Administration

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

Medical Device Recall Report - FDAnews

https://www.fdanews.com/ext/resources/files/03/03-31-14-Recalls.pdf

The majority of recalls with primarily software causes are associated with one of four device panels: radiology, cardiovascular, clinical chemistry, and general hospital. The table …

Analysis and Classification of Medical Device Recalls

https://www.semanticscholar.org/paper/Analysis-and-Classification-of-Medical-Device-Bliznakov-Mitalas/86ecdefa2cbe88783e60055734d7a3cb52f67442

The present analysis reveals the tendencies and the areas to focus for the achievement of highest level of safety and quality in biomedical technology. The results reveal that one in …

An exploratory analysis of U.S. FDA Class I medical …

https://pubmed.ncbi.nlm.nih.gov/30896310/

An exploratory analysis of U.S. FDA Class I medical device recalls: 2014-2018 Medical device manufacturing and distribution is globalised; consequently, medical device failures …

Recalls Background and Definitions | FDA

https://www.fda.gov/safety/industry-guidance-recalls/recalls-background-and-definitions

Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. Market withdrawal: occurs when a product has a …

Analysis and Classification of Medical Device Recalls

https://www.researchgate.net/publication/227032993_Analysis_and_Classification_of_Medical_Device_Recalls

The results reveal that one in every three medical devices, making use of software for their operation, has been recalled due to failure in the software itself. In …

118. An Analysis of Medical Device Recalls

https://www.boisestate.edu/undergraduate-research/2020/04/22/118-an-analysis-of-medical-device-recalls/

A recent study examined cybersecurity attacks in medical devices, then characterized the vulnerabilities based on reports from the CVE and ICS …