—#216414

Product

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

FDA product code: IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K214039
Affected lot / code info: Model 5877533 UDI-DI: 00195278464637, Serial Numbers: LP9490416 LP9490175 LP9490393 LP9490399 LP9490376 LP9490463 LP9443017 LP9442472 LP9443231 LP9442094 LP9443291 LP9443230 LP9440403 LP9442483 LP9440972 LP9440166 LP9440237 LP9440933 LP9440348 LP9442196 LP9440631 LP9440926 LP9441099 LP9441225 LP9441097 LP9440929 LP9441030 LP9440921 LP9441035 LP9440507 LP9440920 LP9440459 LP9440460 LP9441332 LP9442656 LP9443022 LP9440986

Why it was 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.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: GE Medical Systems, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: US Nationwide. Global Distribution.

Timeline

Recall initiated: 2025-09-18
Posted by FDA: 2025-10-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #216414. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.