FDA recall Z-0156-2026

GE Medical Systems, LLC · Class II · device

Product

LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535

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.

Key facts

Status: Ongoing
Initiation date: 2025-09-18
Report date: 2025-10-22
Voluntary/Mandated: Voluntary: Firm initiated
Location: Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0156-2026