GE Medical Systems recalled 31 LOGIQ P10 R4.5 HD ultrasound systems sold nationwide in the United States and globally after discovering UGAP measurements may misstate liver steatosis. The UGAP data may display inaccurate values representing liver steatosis. Healthcare providers and patients should stop using the device immediately and follow the manufacturer’s 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 LOGIQ P10 is a higher-end ultrasound system used by clinicians for diagnostic imaging. Version R4.5.7 refers to the installed software on the affected unit.
UGAP data may misrepresent liver steatosis. This can lead to incorrect assessment of liver fat and potentially inappropriate patient management.
This recall is not described as part of a broader industry pattern.
Hospitals and clinics using the affected LOGIQ P10 systems may need to re-scan patients or adjust interpretations based on unreliable UGAP data. The recall involves 31 units with nationwide and global distribution.
FDA recall page and GE HealthCare recall communications.
Refunds or replacements follow GE Medical Systems recall process, typically within weeks to a couple of months depending on availability.
Keep the recall notice, serial numbers, model numbers, and all correspondence with GE Medical Systems for records.
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 Sold: US Nationwide; Global Distribution Recall Date: 2025-09-18 Quantity: 31 units Price: Unknown
No injuries or incidents have been reported.
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