LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
Pending LLM rewrite. Source: FDA_DEVICE Z-0156-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
The recalled product
- Product
- LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
- Manufacturer
- GE Medical Systems, LLC
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model Number 5877535 UDI-DI: 00195278464668
Distribution
Distributed nationwide across the United States.
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