Summary
The FDA issued a Class I for Philips Lumify Diagnostic Ultrasound System by Philips Ultrasound, LLC. Reason: Ultrasound system may: 1) Not recognize previous transducer registration, prevent scanning, require re-registration with Wi-Fi/cellular access, which .
Details
Source
Device Recall
External ID
Z-0152-2027
Action Date
2026-10-28
Status
Ongoing
Category
device
Product Description
Philips Lumify Diagnostic Ultrasound System
Lot/Code Info: UDI-DI/Software Version: Android: 00884838122116/1.X, 3.X, 4.X, 5.X. iOS: 00884838124141/2.X and 5.X
Quantity Affected: 13,206
Reason for Recall
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-09-24
Company
Bothell, WA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 187 device recalls issued in the same week, part of 480 device-related FDA actions this month.
Philips Ultrasound, LLC has 27 FDA actions in our database, including 4 recalls and 23 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips Ultrasound, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips Ultrasound, LLC have FDA actions?
Philips Ultrasound, LLC has 27 FDA actions in our database, including 4 recalls and 23 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0152-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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