Philips updates safety instructions for ultrasound system after four deaths reported
FDA says the device may fail during critical care and cause delays in treatment.
13 Oct 2026 1 read Compiled with AI
Philips is updating instructions for an ultrasound system after reporting eight serious injuries and four deaths. The Food and Drug Administration said Friday that the software issue can delay the use of the portable Luminy diagnostic ultrasound system. Healthcare professionals received this information as a safety alert regarding the device.
As of Sept. 29, Philips had reported these harms linked to the equipment. The FDA noted the risks stem from a failure in the Lumify Android or iOS applications. These apps sometimes do not recognize a previously registered transducer when used with the device.
When this happens, the system asks users to re-register the devices before scanning. The Lumify device cannot be used on patients until that re-registration is complete. Re-registration requires access to a Wi-Fi or cellular signal to proceed.
This creates a risk for devices used outside of hospitals. Lumify is intended for point-of-care use in ambulances, aircraft and field settings. If Wi-Fi and cellular signal access is limited there, users may be unable to re-register the devices.
Delays to diagnosis or treatment could lead to serious injury or death depending on the patient condition. Loss of scanning functionality or system failure may have greater consequences for Lumify than traditional ultrasound devices. The FDA said this reflects Lumify’s role in real-time decision-making and triage of unstable patients.
To mitigate the risk, Philips recommends healthcare professionals only use Lumify in areas with readily accessible Wi-Fi or cellular signals. The company advises users to always have backup ultrasound devices available for care. A spokesperson wrote that a USB cable connection may disconnect or be unstable, so a taskforce is working on a fix.