Ultrasound system may display inaccurate liver steatosis measurements
GE Medical Systems is recalling LOGIQ P10 series ultrasound systems because the liver steatosis measurement feature may display inaccurate values, potentially leading to incorrect clinical decisions.
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: This is a Class II medical device recall involving a measurement accuracy defect that could lead to inappropriate clinical decisions regarding liver steatosis assessment. The hazard is significant but theoretical, with no deaths, hospitalizations, or confirmed patient injuries reported in the source material, placing it within the 'risk-of-harm' category where injury has not yet been reported.
Plain-English summary
GE Medical Systems is recalling LOGIQ P10 series ultrasound systems, Model 5877534 with software version R4.5.7. Approximately 65 units have been distributed in the United States and globally.
The Ultrasound-Guided Attenuation Parameter (UGAP) measurement feature in affected systems may display inaccurate values when assessing liver steatosis (fatty liver disease). This measurement inaccuracy could lead healthcare providers to make inappropriate clinical decisions based on incorrect diagnostic data.
This recall affects healthcare facilities and diagnostic imaging centers using the affected LOGIQ P10 series ultrasound system. Affected facilities should contact GE Medical Systems for instructions regarding available remediation options such as software updates or device replacement.
The recalled product
- Product
- LOGIQ P10 series with software version R4.5.7 Model Number 5877534
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- measurement-inaccuracy
- diagnostic-error
- liver-steatosis-misassessment
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.
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