FDA-Device2025-10-22Class II
LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533
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.
Sold states
US Nationwide. Global Distribution.
Affected count
37 units
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0157-2026More GE Medical Systems, LLC recalls
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