The U.S. Food and Drug Administration has classified a correction involving Philips Lumify diagnostic ultrasound systems as a Class I recall following reports of four deaths and eight serious injuries associated with device functionality issues.
The FDA announced the classification Oct. 19, 2026, following an early alert issued Oct. 9. A Class I recall is the agency’s most serious recall classification, indicating that use of the affected devices may cause serious injury or death.
According to the FDA, Philips reported four deaths and eight serious injuries associated with issues that could interrupt ultrasound scanning and delay patient care. The reports do not necessarily establish that the devices caused the deaths or injuries.
The correction involves updated instructions for using affected Philips Lumify ultrasound systems. The FDA said the devices are not being removed from service or sale.
One issue involves Lumify software unexpectedly requiring users to re-register an ultrasound transducer that was previously registered. The problem can prevent scanning until the registration process is completed, which requires Wi-Fi or cellular connectivity.
The issue is particularly concerning in prehospital environments, including ambulances, aircraft and field settings, where reliable wireless connectivity may not be available.
Philips has received reports of unexpected re-registration events that prevented ultrasound scanning and delayed patient care in prehospital settings without Wi-Fi or cellular access, according to the FDA.
A separate issue involves the USB cable connection between the Lumify transducer and a compatible smartphone or tablet. An unstable connection or unexpected disconnection during use may interrupt ultrasound imaging and delay patient care.
The Philips Lumify system combines an ultrasound transducer, a mobile application and a compatible Android or iOS device to provide diagnostic ultrasound imaging and fluid flow analysis. The portable technology is used in various healthcare environments, including emergency and mobile care settings.
The FDA warned that interruptions in point-of-care ultrasound imaging could delay diagnosis or treatment, potentially resulting in serious injury or death.
FDA Outlines Safety Precautions
In a Sept. 24 letter to affected customers, Philips Ultrasound recommended precautions to reduce the risk of interrupted scanning and delayed patient care.
The company advised healthcare providers to use Lumify systems only in locations with readily accessible Wi-Fi or cellular service unless a backup ultrasound device is immediately available.
Philips also recommended maintaining backup ultrasound equipment or alternative imaging modalities to support patient care.
Healthcare facilities were instructed to distribute the safety notification to personnel using affected systems and post the notice near the equipment.
The correction affects multiple versions of the Lumify application for Android and iOS devices, including 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.
Philips is developing a software update to address the unexpected transducer registration issue and plans to provide additional instructions when the update becomes available.
The company is also investigating the USB connection issue to determine its cause and identify an appropriate solution.
Healthcare facilities using Philips Lumify ultrasound systems should review the updated instructions and ensure clinical staff and medical imaging personnel understand the potential risks.
U.S. customers with questions may contact the Philips Ultrasound Customer Care Solutions Center at 800-722-9377.
For additional information, including affected products and safety recommendations, visit the FDA’s Philips Lumify ultrasound system recall notice.
