GE Medical Systems, LLC: Medical Device Recall in 2025 - (Recall #: Z-0157-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 18, 2025

Date Posted: October 22, 2025

Recall Number: Z-0157-2026

Event ID: 97726

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.

Status: Ongoing

Product Quantity: 37 units

Code Information:

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

Distribution Pattern:

US Nationwide. Global Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated