Z-0152-2027

Philips Lumify Diagnostic Ultrasound System

Name: Z-0152-2027 Philips Lumify Diagnostic Ultrasound System
Creator: Philips Ultrasound, LLC
Published: 2026-09-24
License: https://open.fda.gov/license/

Philips Ultrasound, LLC / initiated 2026-09-24 / Open, Classified

FDA source

Recall record

Recall number: Z-0152-2027
Status: Open, Classified
Initiated: 2026-09-24
Posted: 2026-10-16
Recalling firm: Philips Ultrasound, LLC
Product: Philips Lumify Diagnostic Ultrasound System
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
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.
FDA root cause: Device Design
Action: On 9/24/2026, correction notices were mailed to customers who were asked to do the following: Until software update is available and installed: " Do not use the affected systems outside of areas with readily accessible Wi-Fi/Cellular (e.g. prehospital transport (ambulance, helicopter) or use outside of a traditional healthcare setting (care in the field). " Always have backup ultrasound devices and/or modalities available for care as advised in the User Guide. " Circulate this notice to all users of the device so that they are aware of the product issue and associated hazard / harm. " Post this notice near the affected unit(s) for ease of reference. " Forward this notice to any area/facility that may have the device. Additionally: 1) Complete and return the response form via email to [email protected] 2) Firm is developing a software update to address the identified registration issue. Firm is also assessing the unstable cable connection issue to identify the appropriate solution. Firm will communicate once the software update is available and provide instructions on any actions required. Questions can be directed to the firm's local representatives or to the Customer Care Solutions Center (1-800-722-9377).
Quantity in commerce: 13,206
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.
Product codes and lots: UDI-DI/Software Version: Android: 00884838122116/1.X, 3.X, 4.X, 5.X. iOS: 00884838124141/2.X and 5.X

Product code IYN

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-10-21. View this recall on fda.gov (opens on fda.gov)