title: Software-related recalls: an analysis of records.
abstract: 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.
authors: Lisa K
authors: LK
authors: Simone
mesh_terms: D057225:Data Mining; D016208:Databases, Factual; D004869:Equipment Safety / Q000706:statistics & numerical data* / Q000639:trends*; D006748:Hospital Departments / Q000706:statistics & numerical data; D057052:Medical Device Recalls; D011358:Product Surveillance, Postmarketing; D012984:Software; D014481:United States; D014486:United States Food and Drug Administration