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.
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| http://dx.doi.org/10.2345/0899-8205-47.6.514 | DOI Listing |
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