|
Early Alert: Diagnostic Ultrasound System Issue from Philips Ultrasound
The FDA is aware that Philips Ultrasound has issued a letter to affected customers recommending all Lumify diagnostic ultrasound systems have updated use instructions.
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.
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.
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.
Questions?
Customers in the U.S. with questions about this recall should contact Philips Ultrasound Customer Care Solutions Center at (800) 722-9377.
|
