HIGH

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

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.

Quick Facts at a Glance

Recall Date
September 18, 2025
Hazard Level
HIGH
Brand
GE Medical Systems
Geographic Scope
1 states

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact GE Medical Systems, LLC or your healthcare provider for instructions. Notification method: Letter

Full Description

LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535. Reason: 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.. Classification: Class II. Quantity: 31 units. Distribution: US Nationwide. Global Distribution.

View Original Recall on FDA - Medical Devices

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Product Classification

Product Details

Model Numbers
Model Number 5877535 UDI-DI: 00195278464668
Serial Numbers: LPZ490338 LPZ490347 LPZ490339 LPZ490147 LPZ490292 LPZ490019 LPZ490252 LPZ490348 LPZ490303 LPZ490304 LPZ490305 LPZ490306 LPZ490340 LPZ490350 LPZ490341 LPZ440658 LPZ440673 LPZ440674 LPZ490337 LPZ440641 LPZ440192 LPZ440258 LPZ440694 LPZ440695 LPZ440692 LPZ440632 LPZ440185 LPZ440107 LPZ440168 LPZ440046 LPZ440549
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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