Z-0157-2026Class II

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

Name: Z-0157-2026 LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533
Creator: GE Medical Systems, LLC
Published: 2025-09-18
License: https://open.fda.gov/license/

GE Healthcare / initiated 2025-09-18 / Open, Classified / root cause: software

FDA source

GE Medical Systems, LLC began a recall of LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533 on 2025-09-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0157-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-18
Posted: 2025-10-15
Recalling firm: GE Healthcare
Product: LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
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.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 37 units
Distribution: US Nationwide. Global Distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0157-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0155-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-15
Z-0156-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-15
Z-0157-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-15

Product code IYN

K214039Class IILogiq P10, Logiq P9, Logiq P8GE Medical Systems Ultrasound and Primary Care Diagnostics / cleared 2022-03-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)