CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Affected Product
The FDA is aware that Philips Ultrasound has issued a letter to affected customers recommending all Lumify diagnostic ultrasound systems have updated use instructions.
Affected devices:
| Software Version | UDI-DI (GTIN) |
|---|---|
| Lumify Diagnostic Ultrasound System iOS (2.X) | 00884838103405 |
| Lumify Diagnostic Ultrasound System iOS (5.0) | 00884838120266 |
| Lumify Diagnostic Ultrasound System iOS (5.1.2) | 00884838124141 |
| Lumify Diagnostic Ultrasound System iOS (5.1.3) | 00884838124141 |
| Lumify Diagnostic Ultrasound System Android (1.X) | 00884838106987 |
| Lumify Diagnostic Ultrasound System Android (3.X) | 00884838100121 |
| Lumify Diagnostic Ultrasound System Android (4.X) | 00884838108455 |
| Lumify Diagnostic Ultrasound System Android (5.1) | 00884838122116 |
| Lumify Diagnostic Ultrasound System Android (5.1.1) | 00884838122116 |
What to Do
To prevent unintended loss or delays in scanning functionality, only use the Lumify diagnostic ultrasound system in areas with readily accessible Wi-Fi/cellular signals unless a backup ultrasound device is immediately available.
On September 24, 2026, Philips Ultrasound sent all affected customers a letter recommending the following actions:
- To prevent unintended loss or delays in scanning functionality, only use the Lumify diagnostic ultrasound system in areas with readily accessible Wi-Fi/cellular signals unless a backup ultrasound device is immediately available.
- Always have backup ultrasound devices and/or modalities available for care.
- Circulate the Philips Ultrasound provided letter to all users of the device so that they are aware of the product issue and its associated hazard/harm.
- Post the notice provided by Philips Ultrasound near the affected unit(s) for ease of reference
Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.
Reason for Alert
Philips Ultrasound stated that due to a software issue, the Lumify Android or iOS application used with its ultrasound transducers may not recognize a previously registered transducer and will prompt users for re-registration without warning prior to point-of-care use. Scanning functionality is prevented until the registration step has been completed. Registration requires Wi-Fi or cellular signal access.
Lumify devices used outside the hospital, such as in ambulances, aircraft, or field settings, are at greater risk due to more limited access to Wi-Fi/cellular signals. Philips has received reports that the unexpected re-registration events have prevented scanning in pre-hospital environments and delayed care to patients. These pre-hospital events occurred outside of Wi-Fi or cellular access.
Philips stated it is developing a software update to address the registration issue. Philips will send a follow-up communication once the software update is available and will provide instructions on any actions required.
Additionally, Philips reported that the connection between the Lumify transducer USB cable to a customer’s tablet or phone may disconnect or have an unstable connection during use, which may disrupt continuous function of the device and result in a delay of care.
Philips stated it is working to assess the cause of the connection issue and identify an appropriate solution. Updates will be communicated to customers as soon as further information is available.
Loss of functionality or system failure during a procedure may result in a delay in diagnosis and/or treatment. Because the Lumify system is intended for point-of-care use, where ultrasound imaging supports rapid diagnosis and treatment; real-time decision-making; triage of unstable patients; and access to diagnostic capabilities in mobile, underserved, or remote settings, loss of functionality or system failure may have greater consequences than with traditional ultrasound devices. Depending on the clinical situation and patient condition, delays in diagnosis or treatment could lead to serious injury or death.
As of September 29, 2026, Philips Ultrasound has reported eight serious injuries and four deaths associated with this issue.
Device Use
The Philips Lumify Ultrasound system consists of the combination of a Philips transducer, the Philips Lumify application, and a compatible Android device or a compatible iOS device. It is indicated for diagnostic ultrasound imaging and fluid flow analysis. The Lumify system is intended for use in environments where health care is provided. The device is transportable and may be used in settings outside of the hospital such as in an ambulance.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact the Philips Ultrasound Customer Care Solutions Center at (800) 722-9377.
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.
- How do I recognize a UDI on a label?
- AccessGUDID database - Identify Your Medical Device
- Benefits of a UDI System
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.