Device product

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

Z-0156-2026

September 18, 2025

Class II

Product summary

Firm: GE Medical Systems, LLC
Event: Event 97726
Status: Ongoing
Classification: Class II
Quantity: 31 units
Official record key: device-enforcement:Z-0156-2026

Official wording

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.

Code information: 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

Distribution pattern: US Nationwide. Global Distribution.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.