LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533

FDA device recall Z-0157-2026 · posted 2025-10-15 · Open, Classified

Recall details

Recalling firm: GE Medical Systems, LLC
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.
Action taken: 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 recall.74084@gehealthcare.com. 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
Status: Open, Classified
Product code: IYN
Quantity affected: 37 units
Distribution: US Nationwide. Global Distribution.
Date initiated: 2025-09-18
Date posted: 2025-10-15
Location: Waukesha, WI

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Related 510(k) clearances

Record	Firm	Date
LOGIQ P10, LOGIQ P9, LOGIQ P8 (K214039)	GE Medical Systems Ultrasound and Primary Care Diagnostics	2022-03-22