FDA-Device2026-10-16Class IPROCESSING DEFECT

Philips Lumify Diagnostic Ultrasound System recalled for connection failures and registration issues

OTHERNationwide distributionMedical devices

What this means

The Philips Lumify portable ultrasound system may fail to recognize previously saved transducer settings, forcing re-registration that requires Wi-Fi or cellular access—unavailable in ambulances, aircraft, or remote field settings. Additionally, the USB cable connection between the transducer and tablet/phone may become unstable or disconnect, disrupting scans. These issues could delay diagnosis or treatment.

If you use a Philips Lumify system, contact Philips immediately for updated software or guidance
Do not rely on the system in settings without reliable Wi-Fi/cellular access until the issue is resolved
Check for connection stability before critical scanning procedures
Report any connection failures or registration problems to Philips

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The agency's original wording

Hazard

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.

Intended for

Adults

Illnesses reported

None reported

Sold states

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.

Affected count

13,206

Manufactured in

22100 Bothell Everett Hwy, Bothell, Washington, United States

Products

Philips Lumify Diagnostic Ultrasound System

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0152-2027

More Philips recalls

FDA-Device2026-09-30
Philips EPIQ Elite ultrasound system recalled for doppler measurement software error

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