Philips updates Lumify ultrasound instructions after scan disruptions

Philips Ultrasound has updated instructions for its Lumify diagnostic ultrasound system after reports that software and transducer connection problems can prevent or delay scanning, the FDA said. The correction does not require removing devices from use or sale. The FDA identified it as the most serious type of recall and warned that using the device without following the updated instructions could cause serious injury or death.

Philips says its app may unexpectedly require transducer re-registration, which needs Wi-Fi or cellular access, and that USB cable connections may disconnect or become unstable. It recommends using Lumify only where Wi-Fi or cellular signals are readily accessible, unless a backup ultrasound device is immediately available. The FDA said Philips reported eight serious injuries and four deaths associated with the issue as of September 29, 2026. Philips is developing a software update for the registration issue and assessing the connection problem, with further customer updates to follow.