Recall Z-1007-2026 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Philips Ultrasound, LLC
Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795234 REF: 795117, 795122
| Date | Dec 31, 2025 (initiated Jul 14, 2022) |
| Status | Completed |
| Reason | Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer. |
| Root cause | Software Design Change |
| Action | On July 18, 2022, Phillips issued a product notification to affected consignees. Philips ask consignees to take the following actions: 1. If the X5-1c transducer is connected to the right-most port (when viewing from the front), this problem will not occur. Please ensure your X5-1c is connected to the right-most connector until the software update (FCO79500561) has been installed. 2. Please retain this letter with your product documentation until the software update (FCO79500561) has been implemented on your system. 3. Please circulate this notice to all users of this device so that they a |
| Quantity | 1,721 systems |
| Distribution | Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Argentina, Australia, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K231190 | EPIQ Series Diagnostic Ultrasound System Philips Ultrasound, LLC, May 12, 2023 |