What is being recalled?

GE Medical Systems LOGIQ P10 ultrasound systems with software version R4.5.7 and Model Number 5877534. The UGAP measurement may display inaccurate liver steatosis values.

Why is this dangerous?

Inaccurate UGAP data could lead to inappropriate clinical decisions affecting patient care.

How many units are affected?

65 units are part of this recall for US nationwide and global distribution.

Hospitals and clinics using the LOGIQ P10 ultrasound system.

What should I do now?

Stop using the device immediately and follow GE’s recall instructions.

Yes. The remedy is to stop use and coordinate with GE Medical Systems or your facility for next steps.

Will I get a replacement or refund?

The recall notice directs users to follow manufacturer instructions. Specific refunds or replacements are not detailed.

Where can I get more information?

See the FDA recall page linked in the notice for detailed guidance.

How do I identify if my device is affected?

Check model number 5877534, software R4.5.7, and the UDI-DI 00195278464644. Review the listed serial numbers.

What about patient care impact during the recall?

Clinicians should follow official guidance and monitor any decision changes prompted by UGAP readings.

What should I tell my hospital procurement team?

Inform them of the 65-unit LOGIQ P10 recall and the device’s potential UGAP data inaccuracy.

What if I ordered the device through a distributor?

Coordinate with the hospital or clinic’s biomedical team and the GE recall contact for instructions.

How long will responses take?

GE will provide next steps per the recall process; users should await official guidance.

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

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

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

1Stop using the product until you confirm whether it is included in the recall.
2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand: GE Medical Systems
Product type: Ultrasound Imaging System
Model numbers: LOGIQ P10 series, Model 5877534, UDI-DI 00195278464644
Sold at: Unknown
Where affected: ALL

Recall Timeline

Key dates and source checks for this recall record.

Recall announced
September 18, 2025
Reported by FDA DEVICE
October 22, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.

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

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

Verify model number 5877534 and software version R4.5.7 on the device label.
Match UDI-DI 00195278464644 to the recall listing.
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.

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Reported Incidents

No injuries or incidents have been reported.

Key Facts

US Nationwide and Global distribution
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

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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