Recall Z-0155-2026— GE Medical Systems, LLC

Name: FDA recall Z-0155-2026
Creator: U.S. Food and Drug Administration
Published: 2025-09-18

Class II · Ongoing

Class II FDA medical device recall by GE Medical Systems, LLC, initiated 2025-09-18. It names one FDA 510(k) clearance: K214039. Product: LOGIQ P10 series with software version R4.5.7 Model Number 5877534. 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..

Recalling firm: GE Medical Systems, LLC
Classification: Class II
Status: Ongoing
Initiated: 2025-09-18
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K214039 — LOGIQ P10, LOGIQ P9, LOGIQ P8GE Medical Systems Ultrasound and Primary Care Diagnostics·cleared 2022-03-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

LOGIQ P10 series with software version R4.5.7 Model Number 5877534

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.