HIGH

GE Medical Systems Recalls LOGIQ P9 Ultrasound System Over Inaccurate Measurements

GE Medical Systems recalled 37 LOGIQ P9 ultrasound systems on September 18, 2025. The devices may display inaccurate liver steatosis data, risking inappropriate clinical decisions. Healthcare providers must stop using the devices immediately and follow recall instructions.

Quick Facts at a Glance

Recall Date
September 18, 2025
Hazard Level
HIGH
Brand
GE Medical Systems
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact GE Medical Systems, LLC or your healthcare provider for instructions. Notification method: Letter

Product Details

The recall affects LOGIQ P9 ultrasound systems with system software version R4.5.7 and Model Number 5877533. These units were distributed nationwide across the United States.

The Hazard

The Ultrasound-Guided Attenuation Parameter (UGAP) measurements may provide inaccurate values for liver steatosis. This defect could result in inappropriate clinical decisions that may impact patient care.

Reported Incidents

There are no reported incidents of injury or death associated with this recall. However, the potential for inappropriate clinical decisions presents a significant risk.

What to Do

Stop using the recalled ultrasound systems immediately. Contact GE Medical Systems or your healthcare provider for further instructions and to follow the recall process.

Contact Information

For more information, call GE Medical Systems at 1-800-XXXX-XXXX or visit their website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0157-2026.

Key Facts

  • 37 units recalled
  • Inaccurate liver steatosis data risk
  • Immediate stop-use required
  • Nationwide distribution
  • Class II recall
View Original Recall on FDA - Medical Devices

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Safety Assessment

Risk LevelHIGH
Severity Score
6/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeUltrasound System
Sold At
Multiple Retailers

Product Details

Model Numbers
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
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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