Recall Z-0155-2026 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
GE Medical Systems, LLC
LOGIQ P10 series with software version R4.5.7 Model Number 5877534
| Date | Oct 15, 2025 (initiated Sep 18, 2025) |
| Status | Open, Classified |
| Reason | The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care. |
| Root cause | Software design |
| Action | An URGENT MEDICAL DEVICE CORRECTION notification letter dated 9/18/25 was sent to customers. Actions to be taken by Customer/User For LOGIQ P9 and LOGIQ P10 series ultrasound systems with system software version R4.5.7, discontinue using the UGAP feature (please see Appendix for product identification). You may continue using other imaging features. After the correction has been implemented, please destroy the installation media for software R4.5.7 at your site. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please |
| Quantity | 65 units |
| Distribution | US Nationwide. Global Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K214039 | LOGIQ P10, LOGIQ P9, LOGIQ P8 GE Medical Systems Ultrasound and Primary Care Diagnostics, Mar 22, 2022 |