GE Medical Systems recalled 65 LOGIQ P10 ultrasound systems nationwide after UGAP measurements may misrepresent liver steatosis readings. The defect could drive inappropriate clinical decisions. Healthcare providers should stop using the devices and follow GE’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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Ultrasound imaging systems are used in hospitals and clinics to visualize internal organs. The LOGIQ P10 series is a high-end platform for diagnostic imaging.
UGAP measurements may misrepresent liver fat levels, potentially affecting diagnostic and treatment decisions.
This recall is not indicated as part of a broader industry pattern.
Immediate halt to use is required to prevent potential misdiagnosis and inappropriate care.
The recall page on the FDA enforcement site and the device label on the hardware.
Processing of replacement or service will follow GE's recall procedures. Specific timelines are not listed.
Keep the recall notice, serial numbers, device labels, communications with GE, and any corrective action taken.
Model: LOGIQ P10 series, software version R4.5.7, Model Number 5877534. UDI-DI: 00195278464644. Serial Numbers include 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, LPX44137
No injuries or incidents have been reported.
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