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Software Quality Lessons From Medical Device Failure Data



D Wallace, David R. Kuhn


Most complex systems today contain software, and systems failures activated by software faults can provide lessons for software development practices and software quality assurance. This report presents an analysis of 342 software-related failures of medical devices that caused no death or injury but led to recalls by the manufacturers. The analysis categorizes the failures by their symptoms and faults. Tables provide methods for preventing and detecting the faults. The nature of the faults provides lessons about the value of generally accepted quality practices for prevention and detection methods applied prior to system release. It also provides some insight into the need for formal requirements specification and for improved testing of complex hardware-software systems.
- 6407
Report Number


high assurance, medical devices, quality practices, software faults, system failures


Wallace, D. and Kuhn, D. (1999), Software Quality Lessons From Medical Device Failure Data, - 6407, National Institute of Standards and Technology, Gaithersburg, MD (Accessed April 17, 2024)
Created November 1, 1999, Updated October 16, 2008