Lumify Ultrasound System

Companies: Philips Ultrasound Llc, 22100 Bothell Everett Highway, Bothell, Washington, United States, 98021.

Potential issues with the Lumify Diagnostic Ultrasound System which may prevent or delay scanning functionality:

Due to a software issue, the Lumify application may not recognize a previously registered transducer and prompt for re-registration (outside of the defined criteria in the user guide) 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 reduced access to wi-fi/cellular. Philips has received reports that these erroneous 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 has identified that the connection between the Lumify transducer USB cable to a customer's tablet/ 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.