Ultrasound systems recalled over inaccurate liver steatosis measurement values
GE is recalling 65 LOGIQ P10 series systems running software R4.5.7 because the Ultrasound-Guided Attenuation Parameter measurement may display inaccurate liver steatosis values.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the record states inaccurate measurements could lead to inappropriate clinical decisions, and no injuries are reported.
Plain-English summary
LOGIQ P10 series ultrasound systems with software version R4.5.7, model number 5877534, are being recalled.
The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. The firm states this could potentially lead to inappropriate clinical decisions impacting overall care.
The recall covers 65 units carrying UDI-DI 00195278464644, with serial numbers including LPX441358, LPX441335, LPX440894, LPX440598 and LPX440898. Distribution was nationwide in the United States and global. The FDA has classified the action as Class II.
Sites running the affected software version should follow GE's instructions and treat UGAP values from that version with caution.
The recalled product
- Product
- LOGIQ P10 series with software version R4.5.7 Model Number 5877534
- Manufacturer
- GE Medical Systems, LLC
- Affected units
- 65
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model 5877534 UDI-DI: 00195278464644
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by GE Medical Systems, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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