FDA Early Alert Flags Philips Lumify Ultrasound Flaw Linked to Four Deaths

The US Food and Drug Administration has issued an early alert about a potentially high-risk issue with the Philips Lumify diagnostic ultrasound system, after Philips Ultrasound reported eight serious injuries and four deaths associated with a software problem that can block scanning when the device has no network connection.

The FDA early alert, issued on October 9, concerns the Lumify app for Android and iOS devices, which connects a Lumify transducer to a smartphone or tablet. According to the FDA, the app may fail to recognise a transducer that was previously registered and prompt the user to register it again without warning. Scanning is blocked until registration is complete, and registration requires Wi-Fi or cellular access.

Pre-hospital settings

The FDA said devices used in ambulances, aircraft and field settings are at greater risk because connectivity there can be limited. Philips has received reports of scanning being prevented and care being delayed in pre-hospital settings outside Wi-Fi or cellular coverage, according to the agency. The notice states: "Loss of functionality or system failure during a procedure may result in a delay in diagnosis and/or treatment."

Philips has also reported a second issue, in which the USB connection between the transducer cable and the tablet or phone may disconnect or become unstable during use, the FDA said. The company is developing a software update for the registration problem and investigating the connection problem, and it plans to send follow-up communications.

As of September 29, 2026, Philips had reported eight serious injuries and four deaths associated with the issue, according to the FDA.

Updated instructions, not a removal

Philips Ultrasound sent a letter to affected customers on September 24, 2026, with updated use instructions. The action does not require devices to be removed from use or sale. According to the FDA's summary of the letter, Philips recommends that customers "only use the Lumify diagnostic ultrasound system in areas with readily accessible Wi-Fi/cellular signals," unless a backup ultrasound device is immediately available, and that backup ultrasound devices or other imaging modalities be kept available.

The letter also asks customers to circulate the notice to all users of the device and to post it near affected units, the FDA said.

The affected software spans several generations of the Lumify app. The FDA lists iOS versions 2.X, 5.0, 5.1.2 and 5.1.3 and Android versions 1.X, 3.X, 4.X, 5.1 and 5.1.1, each identified by its device identifier. The FDA notice does not give a total number of affected devices.

How early alerts work

The FDA lists early alert communications alongside the most serious type of medical device recalls; the agency says such alerts concern corrective actions by companies that it believes are likely to become the most serious type of recall. Philips Ultrasound directs US customers with questions to its Customer Care Solutions Center, and the FDA asks health care professionals and consumers to report problems through its MedWatch program.