FDA Data Reveals Medical Device Recalls Software Woes

According to US Food and Drug Administration records, on average more than 2500 per year recall of medical equipment are issued in United States. Some of these recalls simply require the device to be checked for problems, while others require the device to be returned or destroyed. After identifying FDA classifies the root cause of these recalls into 40 categories, as well as a collection of “other”: situations that include labeling confusion, issues with expiration dates and fake.

Here's a breakdown of the five largest categories of problems found among 56,000 records in the FDA's medical recall database since 2002: device design, process control (which means there was an error in the device's manufacturing process), nonconforming material/component (which means something doesn't meet required specifications), software problems, and packaging.

Software problems broken down into six main reasons, with the biggest challenge undoubtedly being software development. The remaining five, in order: change control; changes in software design; problems with software production or deployment; problems of software design in the production process; and software in the “environment of use”. The latter includes cybersecurity problems or issues with software support, e.g. smartphone app.