Medical devices
Philips updates instructions for ultrasound system linked to four deaths
Philips advises using Lumify only where Wi-Fi or cellular service is available, unless a backup ultrasound device is immediately available.
Philips is advising healthcare professionals to use its Lumify ultrasound system only where Wi-Fi or cellular signals are readily available, unless a backup ultrasound device is immediately available. The instructions address a software issue that can make the system unusable until a transducer is re-registered.
The Lumify app may fail to recognize a previously registered transducer and prompt users to register it again. Re-registration requires Wi-Fi or cellular access, which can delay scans in ambulances, aircraft and field settings. Philips reported eight serious injuries and four deaths as of Sept. 29. The FDA said delays to diagnosis or treatment could cause serious injury or death, depending on the clinical situation and patient condition.
Philips is developing a software update and working to identify a solution to a possible unstable connection between the transducer’s USB cable and a tablet or phone, a company spokesperson told MedTech Dive.
