GE Medical Systems recalled 31 LOGIQ P10 R4.5 HD ultrasound systems on September 18, 2025. The devices may display inaccurate liver steatosis data, risking inappropriate clinical decisions. Healthcare providers must stop using these devices immediately.
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 P10 R4.5 HD ultrasound systems with software version R4.5.7 and model number 5877535. The serial numbers impacted include LPZ490338, LPZ490347, and others. These units were distributed nationwide in the U.S.
The Ultrasound-Guided Attenuation Parameter (UGAP) may show incorrect values indicating liver steatosis. Such inaccuracies could lead to serious clinical misjudgments affecting patient care.
No specific incidents or injuries have been reported in connection with this recall. The potential for inappropriate clinical decisions poses a significant risk.
Patients and healthcare providers should stop using the affected ultrasound systems immediately. For further instructions, contact GE Medical Systems or your healthcare provider. Follow the recall instructions provided in the notification letter.
For more information, contact GE Medical Systems at their customer service number. Visit their website for further recall details.
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