FDA Recalls Attributed to Software Failures

Today FDA released its FY2011 OSEL Annual Report.  Of relevance to medical device software, Figure 5 on page 22 charts the impact of software on medical device recalls.  The figure indicates that last year, about 24% of FDA recalls of medical devices were attributable to software failures. The report also proposes an analogue to "flight data recording" to get better introspection into adverse events on medical devices (page 39).