HIGH

GE Medical Systems LOGIQ P10 Ultrasound System Recalled for UGAP Data Inaccuracy (31 Units, 2025)

GE Medical Systems recalled 31 LOGIQ P10 R4.5 HD ultrasound systems sold nationwide in the United States and globally after discovering UGAP measurements may misstate liver steatosis. The UGAP data may display inaccurate values representing liver steatosis. Healthcare providers and patients should stop using the device immediately and follow the manufacturer’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
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

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About This Product

The LOGIQ P10 is a higher-end ultrasound system used by clinicians for diagnostic imaging. Version R4.5.7 refers to the installed software on the affected unit.

Why This Is Dangerous

UGAP data may misrepresent liver steatosis. This can lead to incorrect assessment of liver fat and potentially inappropriate patient management.

Industry Context

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

Real-World Impact

Hospitals and clinics using the affected LOGIQ P10 systems may need to re-scan patients or adjust interpretations based on unreliable UGAP data. The recall involves 31 units with nationwide and global distribution.

Practical Guidance

How to identify if yours is affected

  1. Check model number 5877535 on the device label or startup screen.
  2. Verify UDI-DI 00195278464668.
  3. Review serial numbers against the recall list.
  4. Confirm UGAP data is not used for decision-making until guidance is issued by GE Medical Systems.

Where to find product info

FDA recall page and GE HealthCare recall communications.

What timeline to expect

Refunds or replacements follow GE Medical Systems recall process, typically within weeks to a couple of months depending on availability.

If the manufacturer is unresponsive

  • Document all contact attempts with GE Medical Systems.
  • Escalate to hospital risk management and consider filing a recall complaint with FDA if the manufacturer is unresponsive.
  • Keep copies of all recall notices and correspondence.

How to prevent similar issues

  • Regularly check for recall updates from GE HealthCare and FDA.
  • Verify device software compatibility before updates.
  • Maintain an inventory of devices with model numbers and serials to quickly identify affected units.

Documentation advice

Keep the recall notice, serial numbers, model numbers, and all correspondence with GE Medical Systems for records.

Product Details

Model Number: 5877535 UDI-DI: 00195278464668 Serial Numbers: LPZ490338, LPZ490347, LPZ490339, LPZ490147, LPZ490292, LPZ490019, LPZ490252, LPZ490348, LPZ490303, LPZ490304, LPZ490305, LPZ490306, LPZ490340, LPZ490350, LPZ490341, LPZ440658, LPZ440673, LPZ440674, LPZ490337, LPZ440641, LPZ440192, LPZ440258, LPZ440694, LPZ440695, LPZ440692, LPZ440632, LPZ440185, LPZ440107, LPZ440168, LPZ440046, LPZ440549 Sold: US Nationwide; Global Distribution Recall Date: 2025-09-18 Quantity: 31 units Price: Unknown

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 31 units recalled
  • Model 5877535, UDI-DI 00195278464668
  • Serial numbers listed in recall
  • Distribution: US Nationwide and Global
  • Hazard: UGAP data may misrepresent liver steatosis
View Original Recall on FDA - Medical Devices

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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
GENERAL
Injury Types
OTHER

Product Classification

Product TypeUltrasound System
Sold At
Multiple Retailers

Product Details

Model Numbers
5877535
Affected States
ALL
Report Date
October 22, 2025
Recall Status
ACTIVE

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