FDA Classifies Philips Lumify Correction as Class I Recall

Philips’ correction for the Lumify ultrasound system has received a Class I recall classification, according to an October 19, 2026, update from the U.S. Food and Drug Administration. The agency says the correction changes instructions for using the system, rather than withdrawing devices from sale or use.

Lumify uses an app and a Philips transducer connected to a compatible device running Android or iOS. According to the FDA, the system is intended for diagnostic ultrasound imaging and analysis of fluid flow in health-care settings. It is portable for use beyond hospitals, including in ambulances.

According to the FDA’s account of information from Philips, the app may stop recognizing a transducer that has already been registered. Users then need to repeat registration before they can scan, a process requiring cellular or Wi-Fi connectivity. The FDA says these unexpected registration requests have blocked scanning in some pre-hospital settings and delayed care. As of September 29, 2026, Philips had recorded four deaths and eight serious injuries associated with that issue, according to the agency.

A separate problem concerns the USB link connecting the transducer to a tablet or phone. Philips stated to the FDA that this connection may become unstable or disconnect while the system is being used, interrupting operation and delaying patient care.

According to the FDA, a September 24, 2026, correction letter from Philips instructed affected customers to limit use to locations with readily accessible cellular or Wi-Fi service, unless another ultrasound device was available immediately. The letter also instructed customers to maintain access to backup ultrasound equipment or alternative modalities.

The FDA identifies the affected iOS releases as 2.X, 5.0, 5.1.2 and 5.1.3. For Android, the listed versions are 1.X, 3.X, 4.X, 5.1 and 5.1.1.

The agency’s recall database records September 24, 2026, as the date Philips began the correction. The entry, posted on October 16, 2026, lists the recall’s status as open and classified.

Philips stated to the FDA that work was underway on a software update addressing the registration problem, while a response to the cable instability remained under evaluation. According to the agency, Philips planned to provide customers with further instructions when that software update became available.

* This article is based on publicly available information at the time of writing.