LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533
Reported: October 22, 2025 Initiated: September 18, 2025 #Z-0157-2026
Product Description
LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533
Reason for Recall
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.
Details
- Recalling Firm
- GE Medical Systems, LLC
- Units Affected
- 37 units
- Distribution
- US Nationwide. Global Distribution.
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533. Recalled by GE Medical Systems, LLC. Units affected: 37 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 22, 2025. Severity: Moderate. Recall number: Z-0157-2026.
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