Medical device makers have been rushing to add AI to their products. While proponents say the new technology will revolutionize medicine, regulators are receiving a rising number of claims of patient injuries.

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.