In 2021, a unit of healthcare giant Johnson & Johnson announced “a leap forward”: It had added artificial intelligence to a ...

One FDA report in June 2025 alleged that AI software used for prenatal ultrasounds was misidentifying foetal body parts.

AI-powered medical devices are linked to injuries, recalls, and lawsuits as regulators struggle to oversee a fast-growing wave of artificial intelligence in healthcare.

Since AI was added to the device, the FDA has received unconfirmed reports of at least 100 malfunctions and adverse events.

Cerebrospinal fluid reportedly leaked from one patient’s nose. In another reported case, a surgeon mistakenly punctured the base of a patient’s skull. In two other cases, patients each allegedly ...