HIGH

GE Medical Systems LOGIQ P10 Ultrasound Systems Recalled for 65 Units in 2025 Over UGAP Data Errors

GE Medical Systems recalled 65 LOGIQ P10 ultrasound systems nationwide after UGAP measurements may misrepresent liver steatosis readings. The defect could drive inappropriate clinical decisions. Healthcare providers should stop using the devices and follow GE’s 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
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL, PREGNANT, PREGNANT

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

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About This Product

Ultrasound imaging systems are used in hospitals and clinics to visualize internal organs. The LOGIQ P10 series is a high-end platform for diagnostic imaging.

Why This Is Dangerous

UGAP measurements may misrepresent liver fat levels, potentially affecting diagnostic and treatment decisions.

Industry Context

This recall is not indicated as part of a broader industry pattern.

Real-World Impact

Immediate halt to use is required to prevent potential misdiagnosis and inappropriate care.

Practical Guidance

How to identify if yours is affected

  1. Verify model number 5877534 and software version R4.5.7 on the device label.
  2. Match UDI-DI 00195278464644 to the recall listing.
  3. Review the listed serial numbers to determine if your unit is affected.

Where to find product info

The recall page on the FDA enforcement site and the device label on the hardware.

What timeline to expect

Processing of replacement or service will follow GE's recall procedures. Specific timelines are not listed.

If the manufacturer is unresponsive

  • Document all outreach attempts to GE and your facility
  • Escalate to hospital risk management or the governing procurement channel
  • If the device remains in use, follow all interim safety measures per hospital policy

How to prevent similar issues

  • In future purchases, check for recall history and ensure recall response plans are in place
  • Verify UDI and serial numbers during device onboarding
  • Maintain service agreements with manufacturers to ensure rapid recall response

Documentation advice

Keep the recall notice, serial numbers, device labels, communications with GE, and any corrective action taken.

Product Details

Model: LOGIQ P10 series, software version R4.5.7, Model Number 5877534. UDI-DI: 00195278464644. Serial Numbers include 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, LPX44137

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 65 units recalled
  • US Nationwide and Global distribution
  • Model 5877534, UGAP R4.5.7, UDI-DI 00195278464644
  • Serial Numbers listed in recall: LPX441358, LPX441335, LPX440894, LPX440598, LPX440898, LPX441357, …
  • Hazard height: UGAP data inaccuracies could influence clinical decisions
  • Remedy requires stopping use and following GE recall instructions

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERALPREGNANTPREGNANT
Injury Types
OTHER

Product Details

Model Numbers
LOGIQ P10 series
Model 5877534
UDI-DI 00195278464644
Affected States
ALL
Report Date
October 22, 2025
Recall Status
ACTIVE

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