Class II
Medical Device Recall: LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
GE Medical Systems, LLC · September 18, 2025
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.
Distribution
US Nationwide. Global Distribution.
States Affected
NATIONWIDE
Quantity Affected
31 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0156-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.