Recall Z-0152-2027 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Philips Ultrasound, LLC
Philips Lumify Diagnostic Ultrasound System
| Date | Oct 16, 2026 (initiated Sep 24, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| 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 th |
| Quantity | 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 |
| FDA record | Open on fda.gov |