The US Food and Drug Administration (FDA) has classified a correction involving Philips Lumify diagnostic ultrasound systems as a Class I recall following reports of 8 serious injuries and 4 deaths associated with device functionality issues as of September 29, 2026. The October 19 classification, the FDA's most serious recall designation, follows an October 9 early alert concerning potential delays in diagnosis and treatment.
According to the FDA, a software issue may cause the Lumify application to unexpectedly fail to recognize a previously registered ultrasound transducer, prompting re-registration without warning. Scanning cannot resume until registration is completed, which requires Wi-Fi or cellular connectivity.
The malfunction poses particular risks in ambulances, aircraft, and field settings, where network access may be limited. Philips has received reports of unexpected reregistration events preventing ultrasound scanning and delaying patient care in prehospital environments without connectivity.
A separate issue involves unstable or disconnected USB connections between the transducer and a compatible smartphone or tablet, potentially interrupting continuous imaging and delaying care.
The FDA warned that loss of functionality during point-of-care ultrasound examinations could interfere with rapid diagnosis, treatment decisions, and triage of unstable patients. Depending on the clinical circumstances, these delays could result in serious injury or death.
Affected systems include Lumify iOS software versions 2.X, 5.0, 5.1.2, and 5.1.3, and Android versions 1.X, 3.X, 4.X, 5.1, and 5.1.1.
In a September 24 letter, Philips instructed customers to use Lumify systems only where Wi-Fi or cellular connectivity is readily accessible unless a backup ultrasound device is immediately available. The company also recommended maintaining alternative imaging capabilities and distributing safety notices to device users.
The recall involves updated operating instructions rather than device removal. The FDA noted that Philips is developing a software update to address unexpected reregistration and separately evaluating the USB connectivity problem.
Source: US Food and Drug Administration
