Philips issues updated use instructions for Lumify ultrasound systems after software glitch risk

Philips Ultrasound has sent a letter to customers of its Lumify diagnostic ultrasound system, advising that the devices require updated use instructions.

The update addresses a software application or transducer connection issue that can cause loss of scanning functionality or delays, which the FDA classifies as a serious recall because it could lead to injury or death if not corrected.

The guidance instructs users to operate the Lumify units only in locations with reliable Wi-Fi or cellular signal, and to have a backup ultrasound device immediately available.

The notice lists the affected models, covering several iOS and Android versions of the Lumify system, and notes that the devices do not need to be removed from service, only the instructions must be followed.