Insight into the incidents comes as AI is beginning to transform the world of health care.
Proponents predict the new technology will help find cures for rare diseases, discover new drugs, enhance surgeons' skill and empower patients.
But a Reuters review of safety and legal records, as well as interviews with doctors, nurses, scientists and regulators, documents some of the hazards of AI in medicine as device makers, tech giants and software developers race to roll it out.
At least 1,357 medical devices using AI are now authorized by the FDA – double the number it had allowed through 2022.
The FDA has received reports involving dozens of other AI-enhanced devices, including a heart monitor said to have overlooked abnormal heartbeats and an ultrasound device that allegedly misidentified fetal body parts.
Researchers from Johns Hopkins, Georgetown and Yale universities recently found that 60 FDA-authorized medical devices using AI were linked to 182 product recalls, according to a research letter published in the JAMA Health Forum in August.
Their review showed that 43% of the recalls occurred less than a year after the devices were greenlighted.
That's about twice the recall rate of all devices authorized under similar FDA rules, the review noted.
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