GE Medical Systems, LLC
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
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.
LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
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 LP9490850
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →