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 series with software version R4.5.7 Model Number 5877534
Model 5877534 UDI-DI: 00195278464644, Serial Numbers: LPX441358 LPX441335 LPX440894 LPX440598 LPX440898 LPX441357 LPX441328 LPX441402 LPX441407 LPX441405 LPX441326 LPX441126 LPX441406 LPX441403 LPX441404 LPX441439 LPX441440 LPX441327 LPX441043 LPX441399 LPX441370 LPX441422 LPX441369 LPX441001 LPX441447 LPX440990 LPX441374 LPX441376 LPX441428 LPX441453 LPX441427 LPX440999 LPX441373 LPX441420 LPX441384 LPX441375 LPX441421 LPX441424 LPX441371 LPX441425 LPX441426 LPX441367 LPX441368 LPX441377 LPX441382 LPX441455 LPX441423 LPX441430 LPX441018 LPX441417 LPX441437 LPX441445 LPX441265 LPX441446 LPX441412 LPX441451 LPX441462 LPX441448 LPX441450 LPX441475 LPX441457 LPX441444 LPX490014 LPX441099 LPX441452 LPX441441 LPX441442 LPX441408 LPX441343 LPX441517 LPX441501
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 →