… declares the table of contents for an article, subtitled Software problems are responsible for 20 recalls a month in IEEE’s Spectrum magazine December 2025 issue (the article is available without an IEEE account: https://spectrum.ieee.org/medical-device-recalls)
The article includes several summary charts about U.S. Food and Drug Administration (FDA) medical device recall data back to 2005, including a breakdown of software causes across 6 subcategories.
The largest software problem category by far – 82% – is “software design.”
There are at least two takeaways:
- It is not a good thing for medical device software issues to make the largest engineering professional association’s general publication.
- Just “slinging code” is not enough … good analysis and design is the foundation for reducing risk.
There are also at least two inferences we can make from the second observation above:
- AI may help with originating, proofing, and testing code at a low level, but it cannot substitute (yet) for good human macro architecture and design. Cutting corners in processes other than coding has significant medical device risk implications, especially for causing future medical device software problems.
- Cybersecurity is as much a software analysis and design effort as it is a software coding effort. The more cybersecurity risk that a device has, the more attention will be needed to integrate and initiate cybersecurity work across the entire software process, including operation in the market. This is also a regulatory expectation and another source for future medical device software problems.
Additional information about FDA recalls and causes can be found at:
- SoftwareCPR recall and warning letter updates: https://www.softwarecpr.com/tag/fda/
- FDA medical device recall database: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm
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