The FDA has published a report on a letter Philips Ultrasound issued to customers about new use instructions for all Lumify diagnostic ultrasound systems.

The company is telling consumers to only use the systems in areas with readily accessible Wi-Fi / cellular signals unless a backup ultrasound device is immediately available in order to prevent unintended loss or delays in scanning functionality.

Due to a software issue, the Lumify Android or iOS application used with its ultrasound transducers may not recognize a previously registered transducer and will prompt users for re-registration without warning prior to point-of-care use. Devices used outside the hospital are at higher risk due to more limited access to Wi-Fi or cellular signals. These unexpected re-registrations have prevented scanning in pre-hospital environments and delayed care.

The connection between the Lumify transducer USB cable to a customer's tablet or phone may also disconnect or have an unstable connection during use, which may disrupt continuous function of the device. 

As of September 29, 2026, Philips has reported eight serious injuries and four deaths associated with this issue.