GE Medical Systems recalled 65 units of its LOGIQ P10 series ultrasound device on September 18, 2025. The device may show inaccurate liver steatosis measurements, risking inappropriate clinical decisions. Healthcare providers must cease use immediately and follow recall instructions.
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.
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
The recall affects the LOGIQ P10 series ultrasound device, model number 5877534 with software version R4.5.7. These units were distributed nationwide in the U.S. and globally.
The Ultrasound-Guided Attenuation Parameter (UGAP) may provide inaccurate measurements of liver steatosis. This inaccuracy could lead to incorrect clinical decisions impacting patient care.
No specific incidents or injuries have been reported related to this recall. The risk level is classified as high due to potential misdiagnosis.
Stop using the device immediately. Contact GE Medical Systems, LLC or your healthcare provider for instructions on returning the device.
For further information, visit the GE Medical Systems website or call customer service at 1-800-XXX-XXXX.
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