GE Medical Systems recalled 37 LOGIQ P9 R4.5 ultrasound systems sold nationwide in the United States and globally after regulators flagged UGAP measurements that may misrepresent liver steatosis. The UGAP data may display inaccurate values representing liver steatosis, potentially guiding inappropriate clinical decisions. Clinicians should stop using the affected devices and await recall guidance.
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 P9 is a high-end ultrasound system used for diagnostic imaging in clinical settings. It is employed by healthcare professionals to assess organ structure and function.
UGAP is used to measure hepatic steatosis. Inaccurate UGAP readings could misrepresent liver fat levels and influence treatment decisions.
This recall is not part of a broader industry pattern.
Hospitals may need to halt use of the affected devices, coordinate replacements or repairs, and re-evaluate recent patient imaging relying on UGAP data. The recall could affect patient management and operational costs.
Serial numbers and model identifiers are on the device label and in the recall notice; UDI-DI is listed as part of the model information.
4-8 weeks for replacement or refund processing after you submit a claim.
Save the recall notice, capture device serial numbers, and maintain all correspondence with GE and hospital records.
Model: 5877533 UDI-DI: 00195278464637 Serial numbers: LP9490416, LP9490175, LP9490393, LP9490399, LP9490376, LP9490463, LP9443017, LP9442472, LP9443231, LP9442094, LP9443291, LP9443230, LP9440403, LP9442483, LP9440972, LP9440166, LP9440237, LP9440933, LP9440348, LP9442196, LP9440631, LP9440926 Quantity recalled: 37 units Distribution: US Nationwide, Global Sold from: Unknown Price: Unknown Country of origin: Unknown
No injuries or incidents have been reported.
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