The FDA issued an early alert this week about the potentially high-risk issue with the diagnostic system’s software. The agency uses early alerts to warn about products with potentially high safety risks before they are classified as a recall.
“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,” the FDA said in its alert. “Scanning functionality is prevented until the registration step has been completed. Registration requires Wi-Fi or cellular signal access.”
The ultrasound 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,” the FDA said in the alert.
Due to Lumify’s use in pre-hospital settings, system failure or loss of functionality could lead to more severe consequences than traditional in-hospital diagnostic systems. A delay in diagnosis and treatment could lead to serious injuries or death, the FDA said.
“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,” the FDA said. “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.”
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The company also reported that the connection between the Lumify transducer USB cable and the user’s tablet or phone may disconnect or have an unstable connection, which may disrupt continuous function and delay care.
“Philips recognizes the role of the Lumify Ultrasound system in access to care,” a Philips spokesperson told MassDevice. “Our Ultrasound business has mobilized a dedicated task force to urgently address this situation, including offering customized advice and support to customers who are impacted.”
On Sept. 24, Philips issued a letter to customers recommending using Lumify only in areas where Wi-Fi and cell service are readily accessible unless a backup ultrasound device is available.
Philips says it’s developing a software update to address the registration issue and assessing the cause of the USB connection issue. The Philips Foundation is also supporting customers with Lumify systems in low-resource areas to provide additional support for continued access to diagnostic care, the spokesperson said.
