SeriousFDAOngoing
Can cause serious harm or death.
Philips Lumify Diagnostic Ultrasound System
Check the device or its packaging for
UDI-DI/Software Version: Android: 00884838122116/1.X, 3.X, 4.X, 5.X. iOS: 00884838124141/2.X and 5.X
- 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.
- Distributed
- 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.
- Company
- Philips Ultrasound, LLC
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-0152-2027 · retrieved 16 October 2026
Read the official notice