AI in the OR raises safety alarms as malfunctions and lawsuits mount

Reuters documents safety concerns with AI-enabled medical devices, notably Johnson & Johnson’s Acclarent TruDi Navigation System, which added AI in 2021 and is tied to malfunctions and injuries, including misidentified anatomy and strokes, with several lawsuits alleging AI contributed to harm. The FDA reports thousands of AI-powered device alerts and dozens of recalls as regulators struggle to keep pace with rapid AI adoption in medicine, highlighting ongoing questions about safety and oversight as AI expands in the field.