Class II

Medical Device Recall: LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533

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

37 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0157-2026

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.

GE Medical Systems, LLC Medical Device Recall: LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533 | SafeCheck