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GE Medical Systems, LLC recalls LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
Recalled October 22, 2025 · FDA recall Z-0156-2026 · GE Medical Systems
Hazard
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. · FDA Class II
Units
31 units
Sold at
US Nationwide. Global Distribution.
Description
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.
Product
LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
Manufacturer(s)
GE Medical Systems, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →