Z-0155-2026Class II

LOGIQ P10 series with software version R4.5.7 Model Number 5877534

Name: Z-0155-2026 LOGIQ P10 series with software version R4.5.7 Model Number 5877534
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 P10 series with software version R4.5.7 Model Number 5877534 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-0155-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-18
Posted: 2025-10-15
Recalling firm: GE Healthcare
Product: LOGIQ P10 series with software version R4.5.7 Model Number 5877534
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: 65 units
Distribution: US Nationwide. Global Distribution.
Product codes and lots: Model 5877534 UDI-DI: 00195278464644, Serial Numbers: LPX441358 LPX441335 LPX440894 LPX440598 LPX440898 LPX441357 LPX441328 LPX441402 LPX441407 LPX441405 LPX441326 LPX441126 LPX441406 LPX441403 LPX441404 LPX441439 LPX441440 LPX441327 LPX441043 LPX441399 LPX441370 LPX441422 LPX441369 LPX441001 LPX441447 LPX440990 LPX441374 LPX441376 LPX441428 LPX441453 LPX441427 LPX440999 LPX441373 LPX441420 LPX441384 LPX441375 LPX441421 LPX441424 LPX441371 LPX441425 LPX441426 LPX441367 LPX441368 LPX441377 LPX441382 LPX441455 LPX441423 LPX441430 LPX441018 LPX441417 LPX441437 LPX441445 LPX441265 LPX441446 LPX441412 LPX441451 LPX441462 LPX441448 LPX441450 LPX441475 LPX441457 LPX441444 LPX490014 LPX441099 LPX441452

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0155-2026
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)