Philips Ultrasound, Llc: System, Imaging, Pulsed Doppler, Ultrasonic

Recall Summary Philips Lumify Diagnostic Ultrasound Systems are recalled due to two potential problems: the system may fail to recognize previously registered transducers and require re-registration in areas without Wi-Fi or cellular access (such as ambulances or aircraft), and the connection between the transducer cable and the tablet/phone may become unstable or disconnect during use. These issues could delay diagnosis and treatment. The affected systems have been distributed nationwide in the U.S. and internationally.

Recalling firm: Philips Ultrasound, LLC
Product: Philips Lumify Diagnostic Ultrasound System
Reason: Ultrasound system may: 1) Not recognize previous transducer registration, prevent scanning, require re-registration with Wi-Fi/cellular access, which may be unavailable outside of the hospital (ambulances/aircraft/field); 2) At connection between transducer USB cable to tablet/phone, there may be an unstable connection/may disconnect disrupting function. May cause diagnosis/treatment delay.
Classification: Class II
Category: medical device recall
Country: United States
Agency: FDA-DEVICES
Recall date: 2026-09-24
Status: Open, Classified
Areas affected: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution: Worldwide - US Nationwide distribution including in the states of CA, MA, IL, NY, OR, GA, TX, WA, FL, PA, WI, LA, NJ, KY, VA, MS, AZ, SC, CT, MN, UT, OH, AL, MI, NH, MO, TN, IN, DC, NE, NM, MT, NV, NC, MD, IA, SD, VT, KS, AK, CO, ID, OK, WV, AR, RI, ME, WY, HI, DE, ND and the countries of CA,...

Recall details on Nibble Recalls: https://trynibble.app/recalls/99ddfadd-4f40-45e0-a6e7-79f73f14948c