Philips updated the instructions for using its Lumify ultrasound system after receiving reports of eight serious injuries and four deaths through September 29, according to an early notification published by the U.S. Food and Drug Administration (FDA). The agency said a software issue can delay use of the portable device, particularly outside hospitals where Wi‑Fi or cellular network connectivity may not be available.
How does the issue appear?
The Lumify application on Android or iOS devices may fail to recognize a previously registered probe, prompting the user to register it again. The device cannot perform an examination of patients until this step is completed, and the step requires a Wi‑Fi network or cellular service connection.
Philips said it had received reports of cases in which unexpected re-registration disrupted examinations and delayed care, with the reports concentrated in environments lacking wireless or cellular connectivity. A company spokesperson also wrote to MedTech Dive that the connection between the probe’s USB cable and the tablet or phone may be interrupted or unstable.
Why does this issue matter in field devices?
Lumify was designed for use at the point of care and is used in ambulances, aircraft, and field environments. The FDA believes that loss of imaging function or system failure may have greater consequences than failures of conventional ultrasound devices because Lumify is used to make immediate decisions, triage unstable patients, and provide diagnostic capabilities in mobile, remote, or underserved areas.
According to the agency, delayed diagnosis or treatment may result in serious injury or death, depending on the patient’s clinical condition. The source does not establish that each of the four cases resulted in the same way, but it links the reported risk to delays in using the device under conditions of disrupted connectivity.
Temporary measures and the expected update
Philips recommends that healthcare workers use Lumify only in locations where Wi‑Fi or cellular connectivity is readily available, unless a backup ultrasound device is immediately available. It also recommends keeping alternative imaging devices or methods ready while providing care.
The company had notified customers of the issue the previous month and is developing a software update to address it, while also working to determine the appropriate solution to the USB connection problem. Philips announced that it had formed a dedicated task force to provide advice and support to customers affected by the device correction procedure.
What remains unresolved?
The source does not specify when the software update will be released, nor does it yet clarify whether the final solution will address only the application issue or also the connection between the probe and the device. The current recommendations therefore remain risk-reduction measures, not a substitute for a final fix that ensures imaging can continue in environments where network connectivity is unavailable.