FDA-Device2025-10-22Class II
LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
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
31 units
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0156-2026More GE Medical Systems, LLC recalls
- FDA-Device2026-06-17GE HealthCare Allia IGS 3 Pulse angiographic X-ray system recalled for electrical shock risk to service personnel
- FDA-Device2026-06-17GE Allia IGS Pulse X-ray system recalled for electrical shock risk to service personnel
- FDA-Device2026-06-17GE HealthCare Allia Moveo X-ray system recalled for electrical shock risk to service personnel
- FDA-Device2026-06-17GE Allia IGS 5 Pulse angiographic X-ray system recalled for electrical shock risk to service personnel
- FDA-Device2026-06-17GE Allia IGS 7 Pulse X-ray system recalled for electrical shock risk to service personnel
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