On September 24, 2026, Philips Ultrasound, LLC initiated a Class I recall for its Lumify Diagnostic Ultrasound System. The recall affects devices distributed worldwide, including across the United States and numerous other countries.

The recall was prompted by issues that may prevent the ultrasound system from recognizing previous transducer registration and could disrupt function due to unstable connections, potentially causing delays in diagnosis and treatment.

Press Release: Food and Drug Administration

Published October 28, 2026. Reproduced in full from the Food and Drug Administration.

Philips Ultrasound, LLC medical device recall

  • Recalling company: Philips Ultrasound, LLC
  • Classification: Class I (the most serious type)
  • Recall numbers: Z-0152-2027
  • Status: Ongoing
  • 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, NO, HR, DE, KR, GB, ES, FI, PL, AU, TH, SG, NL, RO, CH, FR, MM, MX, BE, DK, MY, SE, LB, SI, BR, CL, GR, PH, CN, ID, LT, HK, MQ, JP, IT, IE, IL, AT, TW, AE, SA, HU, RU, VN, NZ, TR, SK, ZA, KE, AR, NP, PK, UY, DO, MN, LK, GT, BD, IS, IN, NI, LY, CY, CZ, SV, PA, BG, PE, EC, CO, VE, UZ, YE, KW, DZ, LU, EG, EE, UA, LV, KZ, TZ, MD, JO, GY, QA, MU, AM, OM, PT, TN, NG, BO, PF, ZM, GF, YT, ME, GD, RS, BW, GP, RE, MT, CR, MA, CI, NC, BA, SR, CG, TL, GH, AL, MV, XK, BN, LS, MK, CM, TT, ZW, BH, PS, HN, MC, WS, JE, PM, AZ.
  • Recall started: September 24, 2026

What was recalled

Philips Lumify Diagnostic Ultrasound System

Why

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.

This medical device recall appears in the FDA's weekly enforcement report. Details: FDA recall event 99878.