Published October 9, 2026. The U.S. Food and Drug Administration issued a potentially high-risk early alert covering Philips Lumify diagnostic ultrasound systems after reports that software and connection problems can interrupt point-of-care scanning.
The FDA said Philips had reported eight serious injuries and four deaths associated with the issue as of September 29. The agency’s notice does not say that every Lumify system will fail, but it warns that a loss of scanning capability can delay diagnosis or treatment in time-sensitive settings.
Which Lumify systems are affected
The alert covers multiple iOS and Android versions of the Lumify Diagnostic Ultrasound System. The listed iOS software versions are 2.X, 5.0, 5.1.2 and 5.1.3. The listed Android versions are 1.X, 3.X, 4.X, 5.1 and 5.1.1.
Lumify pairs a Philips transducer and mobile application with a compatible phone or tablet. It is designed for diagnostic ultrasound imaging and blood-flow analysis and can be used in hospitals, ambulances, aircraft and other mobile or remote care settings.
What can go wrong
According to the FDA, the Lumify app may unexpectedly fail to recognize a previously registered transducer and require the user to register it again before scanning. Re-registration requires Wi-Fi or cellular access. Philips has received reports that this prevented scans and delayed care in pre-hospital environments where connectivity was unavailable.
The company also reported that the USB connection between a Lumify transducer and a phone or tablet may disconnect or become unstable during use. That can interrupt continuous operation and delay care. Philips is developing a software update for the registration issue and is separately assessing the connection problem, the FDA said.
FDA and Philips instructions
- Use Lumify only where Wi-Fi or cellular service is readily available, unless a backup ultrasound device is immediately available.
- Keep backup ultrasound equipment or another imaging option available for care.
- Share Philips’ customer letter with everyone who uses the system.
- Post the notice near affected units so users can see the warning before use.
- Continue checking the FDA alert for updates and software-remediation instructions.
Philips sent its affected-customer letter on September 24. The FDA is still reviewing the matter, so the early alert may be updated as the agency receives additional information. An early alert is not the same as a final recall classification.
Why the risk is greater outside hospitals
Point-of-care ultrasound is often used to support rapid triage and treatment decisions. In an ambulance, aircraft or remote location, a surprise registration prompt can be especially consequential because connectivity and substitute imaging may be limited. The FDA said a delay in diagnosis or treatment could, depending on the patient and clinical situation, lead to serious injury or death.
U.S. customers with questions or product problems can contact the Philips Ultrasound Customer Care Solutions Center at 800-722-9377. Health professionals and consumers can also report adverse events or quality problems through the FDA’s MedWatch program.
For related coverage, see AskNovus’s report on the FDA’s new salt-substitute rule and the latest Health News.
Official source
Read the FDA’s October 9 early alert, including the complete software-version and UDI list. The FDA’s live notice should be treated as controlling if details change.
Featured image: National Cancer Institute via Unsplash. The photo is illustrative and does not show a Philips Lumify device.