Class 1 Device Recall Lumify Diagnostic Ultrasound System

• Date Initiated by Firm: September 24, 2026
• Date Posted: October 16, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0152-2027
• Recall Event ID: 99878
• 510(K)Number: K242519 K242670
• Product Classification: System, imaging, pulsed doppler, ultrasonic - Product Code IYN
• Product: Philips Lumify Diagnostic Ultrasound System
• Code Information: UDI-DI/Software Version: Android: 00884838122116/1.X, 3.X, 4.X, 5.X. iOS: 00884838124141/2.X and 5.X
• FEI Number: 3019216
• Recalling Firm/ Manufacturer: Philips Ultrasound, LLC; 22100 Bothell Everett Hwy; Bothell WA 98021-8431
• For Additional Information Contact: Philips Customer Care Solutions Center; 800-722-9377
• Manufacturer 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 Determined 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 Philips.Recall@philips.com 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = IYN