GE Medical Systems recalled 37 LOGIQ P9 ultrasound systems on September 18, 2025. The devices may display inaccurate liver steatosis data, risking inappropriate clinical decisions. Healthcare providers must stop using the devices 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
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The recall affects LOGIQ P9 ultrasound systems with system software version R4.5.7 and Model Number 5877533. These units were distributed nationwide across the United States.
The Ultrasound-Guided Attenuation Parameter (UGAP) measurements may provide inaccurate values for liver steatosis. This defect could result in inappropriate clinical decisions that may impact patient care.
There are no reported incidents of injury or death associated with this recall. However, the potential for inappropriate clinical decisions presents a significant risk.
Stop using the recalled ultrasound systems immediately. Contact GE Medical Systems or your healthcare provider for further instructions and to follow the recall process.
For more information, call GE Medical Systems at 1-800-XXXX-XXXX or visit their website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0157-2026.
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