Philips Lumify Class I Recall Addresses Loss of Scanning
Philips is correcting Lumify use instructions after unexpected transducer re-registration and unstable USB connections could prevent or interrupt scanning. FDA's October 19 communication confirms Class I recall status; the correction does not involve removing devices.
Decision support
Decision summary
Official recall information is separated from MedTech Current editorial analysis.
Official recall information
What happened
The Lumify application may unexpectedly fail to recognize a previously registered transducer, preventing scanning until registration is repeated with Wi-Fi or cellular access. A separate unstable USB connection can disrupt operation. Philips initiated the correction on September 24, 2026; FDA's October 19 communication announced Class I classification.
MedTech Current analysis
Why it matters
Loss of scanning can delay diagnosis or treatment, particularly in prehospital settings without network access. As of September 29, Philips had reported eight serious injuries and four deaths associated with the issue; the communication does not establish that the defect caused every reported outcome.
Actions by role
MedTech Current analysis — editorial interpretation, not FDA-authored guidance.
- MedTech Current analysisR&D teamsReview offline readiness and recovery testing for unexpected registration-state changes and disrupted physical connections in intended use environments.
Official recall information
Official actions
According to FDA's current Lumify safety communication:
- Use Lumify only where Wi-Fi or cellular signals are readily accessible, unless a backup ultrasound device is immediately available.
- Always have backup ultrasound devices and/or modalities available for care.
- Circulate the Philips letter to all device users and post the notice near affected systems.
Detailed recall information
Detailed sourced information from the published Recall Brief follows.
What changed
Philips Ultrasound, LLC initiated a correction for its Lumify diagnostic ultrasound system on September 24, 2026. FDA’s matching recall record, Z-0152-2027, was posted on October 16 and lists the recall as Class I, with status “Open, Classified.” FDA updated its public safety communication on October 19 to announce the classification, following an October 9 Early Alert. The correction updates use instructions and does not involve removing devices from where they are used or sold.
The Lumify application may unexpectedly fail to recognize a previously registered transducer. Scanning is unavailable until re-registration is completed, requiring Wi-Fi or cellular access. FDA highlights greater risk in ambulances, aircraft and field settings with limited connectivity. Separately, an unstable USB connection between the transducer cable and a phone or tablet may interrupt operation.
Either problem can delay diagnosis or treatment. As of September 29, Philips had reported eight serious injuries and four deaths associated with the issue. These are manufacturer-reported associated events, not confirmation that the defect caused every reported outcome.
Who and what are affected
FDA’s current safety communication identifies the Lumify application versions below. They are application versions, not mobile operating-system versions.
| Platform | Application versions listed by FDA |
|---|---|
| iOS | 2.X, 5.0, 5.1.2, 5.1.3 |
| Android | 1.X, 3.X, 4.X, 5.1, 5.1.1 |
The matching CDRH record uses broader version-family notation: iOS 2.X and 5.X; Android 1.X, 3.X, 4.X and 5.X. It records worldwide distribution, including the United States. The safety communication provides version-specific UDI-DIs for identification. Both sources concern the same registration and USB-connection correction under event 99878.
Official actions
According to FDA’s current safety communication, users should:
- Use Lumify only where Wi-Fi or cellular signals are readily accessible, unless a backup ultrasound device is immediately available.
- Always have backup ultrasound devices and/or modalities available for care.
- Circulate the Philips letter to all users and post the notice near affected systems.
The communication says Philips is developing a registration-related software update and will issue further instructions when it is available. The company is also investigating the USB connection issue. An available software fix has not been announced in this communication.
As an engineering interpretation, R&D teams can use the case to review offline readiness, unexpected registration-state changes and recovery from disrupted connections. Such reviews should reflect intended transport and field environments. These are MedTech Current’s analytical observations, not additional FDA requirements or clinical instructions.