What device is recalled in this notice?

The GE Medical Systems LOGIQ P9 R4.5 ultrasound system, model 5877533 with UDI-DI 00195278464637, distributed nationwide in the US and globally.

What is the hazard associated with the recall?

UGAP measurement data may misrepresent liver steatosis, which could lead to inappropriate clinical decisions.

Are there reported injuries or deaths?

No injuries or incidents have been reported at this time.

Who should stop using the device?

Patients and healthcare providers should stop using the affected ultrasound systems immediately and follow the manufacturer’s recall instructions.

How can I identify if my device is affected?

Check the model number 5877533, the UDI-DI 00195278464637, and the serial numbers listed in GE’s recall notice.

How do I obtain a replacement or refund?

Follow the recall instructions and contact GE Medical Systems, LLC for guidance on replacement or refund options.

Where can I find the official recall notice?

The FDA recall enforcement page linked in the notice provides official details and steps.

What if my facility uses multiple GE ultrasound systems?

Coordinate with your facility’s biomedical engineering team and GE Medical Systems for instructions on which units are affected.

Will the device be fixed, or must it be replaced?

The recall notice mentions following GE’s instructions which may include replacement or service options.

How long might replacement or refund take?

Remedies in recalls typically involve several weeks; applicants are advised to expect 4-8 weeks for processing.

Can I still use other GE imaging systems safely?

Use only devices not listed in the recall notice and monitor GE’s guidance for any required software updates.

Where should I report issues or seek further information?

Contact GE Medical Systems, LLC and refer to the FDA recall page for official guidance.

HIGHSeptember 18, 2025

GE Medical Systems LOGIQ P9 R4.5 Ultrasound System Recalled for Inaccurate Liver Readings (37 Units)

GE Medical Systems recalled 37 LOGIQ P9 R4.5 ultrasound systems sold nationwide in the United States and globally after regulators flagged UGAP measurements that may misrepresent liver steatosis. The UGAP data may display inaccurate values representing liver steatosis, potentially guiding inappropriate clinical decisions. Clinicians should stop using the affected devices and await recall guidance.

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 P9 is a high-end ultrasound system used for diagnostic imaging in clinical settings. It is employed by healthcare professionals to assess organ structure and function.

Why This Is Dangerous

UGAP is used to measure hepatic steatosis. Inaccurate UGAP readings could misrepresent liver fat levels and influence treatment decisions.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Hospitals may need to halt use of the affected devices, coordinate replacements or repairs, and re-evaluate recent patient imaging relying on UGAP data. The recall could affect patient management and operational costs.

Practical Guidance

How to identify if yours is affected

Verify model number 5877533 on the device label.
Cross-check UDI-DI 00195278464637 with GE documentation.
Compare serial numbers against the provided GE list.
Review the recall notice for additional identifiers.

Where to find product info

Serial numbers and model identifiers are on the device label and in the recall notice; UDI-DI is listed as part of the model information.

What timeline to expect

4-8 weeks for replacement or refund processing after you submit a claim.

If the manufacturer is unresponsive

Document all communications with GE or the hospital’s risk management.
Escalate to the FDA MedWatch recall system if GE is unresponsive.

How to prevent similar issues

Keep device firmware updated per GE guidance.
Verify recall status before using imaging devices.
Maintain an up-to-date inventory of GE ultrasound systems and serials to quickly identify affected units.

Documentation advice

Save the recall notice, capture device serial numbers, and maintain all correspondence with GE and hospital records.

Product Details

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 Quantity recalled: 37 units Distribution: US Nationwide, Global Sold from: Unknown Price: Unknown Country of origin: Unknown

Reported Incidents

No injuries or incidents have been reported.

Key Facts

37 units recalled
Model 5877533; UDI-DI 00195278464637
Serial numbers list contains 40+ entries
UGAP accuracy issue related to liver steatosis readings
Distribution includes US nationwide and global
Stop-use-immediately and follow GE recall instructions

View Original Recall on FDA - Medical Devices

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Safety Assessment

Risk LevelHIGH

Severity Score

7/ 10

Affected Groups

GENERAL

Injury Types

OTHER

Product Classification

CategoryHealth & Personal Care › Medical Imaging Equipment

Product TypeUltrasound System

Product Details

Aug 22, 2025

GE Medical Systems

If a