[pending] 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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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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