LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
FDA Recall Z-0156-2026 · Posted 2025-10-15
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Recalling FirmGE Medical Systems, LLC
Recall StatusOpen, Classified
Product CodeIYN
Date Initiated2025-09-18
Product Quantity31 units
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.
Firm Action
An URGENT MEDICAL DEVICE CORRECTION notification letter dated 9/18/25 was sent to customers.
Actions to be taken by Customer/User
For LOGIQ P9 and LOGIQ P10 series ultrasound systems with system software version R4.5.7, discontinue using the UGAP feature (please see Appendix for product identification). You may continue using other imaging features.
After the correction has been implemented, please destroy the installation media for software R4.5.7 at your site.
Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions.
Please retain this document for your records.
Please complete and return the attached acknowledgement form to [email protected].
GE HealthCare will correct all affected products at no cost to you.
A GE HealthCare representative will contact you to arrange for the correction.
If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Root Cause
Software design
Distribution Pattern
US Nationwide. Global Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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