Software-related recalls: an analysis of records.

Public and internal databases were examined to evaluate software-related recalls in the medical device industry sector. In the analysis of recalls reported from 2005 through 2011, 19.4% of medical device recalls are related to software. This paper includes analysis results, challenges faced in determining the causes, and examples and trends in software-related recalls. This information can be useful in enhancing our understanding of why medical devices fail, and it can help to improve medical device safety, and patient and public health.