Abstract
In Brief Medical device recalls for software-related issues for 2009 were collected from the Food and Drug Administration database and analyzed. The recalls were analyzed by classifications, device categories, and failure symptoms. The results indicate the growing importance of software in the domain of medical devices and in medical device problems. The study also presents some suggestions for both device companies and biomedical and clinical engineers. Medical device recalls for software-related issues for 2009 were collected from the Food and Drug Administration database and analyzed. The recalls were analyzed by classifications, device categories, and failure symptoms. The results indicate the growing importance of software in the domain of medical devices and in medical device problems. The study also presents some suggestions for both device companies and biomedical and clinical engineers.
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