HIGH

GE Medical Systems Recalls Ultrasound Device Over Inaccurate Data

GE Medical Systems recalled 65 units of its LOGIQ P10 series ultrasound device on September 18, 2025. The device may show inaccurate liver steatosis measurements, risking inappropriate clinical decisions. Healthcare providers must cease use 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 the LOGIQ P10 series ultrasound device, model number 5877534 with software version R4.5.7. These units were distributed nationwide in the U.S. and globally.

The Hazard

The Ultrasound-Guided Attenuation Parameter (UGAP) may provide inaccurate measurements of liver steatosis. This inaccuracy could lead to incorrect clinical decisions impacting patient care.

Reported Incidents

No specific incidents or injuries have been reported related to this recall. The risk level is classified as high due to potential misdiagnosis.

What to Do

Stop using the device immediately. Contact GE Medical Systems, LLC or your healthcare provider for instructions on returning the device.

Contact Information

For further information, visit the GE Medical Systems website or call customer service at 1-800-XXX-XXXX.

Key Facts

  • 65 units recalled
  • Class II recall
  • Inaccurate liver measurement risk
  • Immediate stop-use requested
View Original Recall on FDA - Medical Devices

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Safety Assessment

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

Product Classification

Product TypeUltrasound Device
Sold At
Multiple Retailers

Product Details

Model Numbers
Model 5877534 UDI-DI: 00195278464644
Serial Numbers: 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 LPX441377 LPX441382 LPX441455 LPX441423 LPX441430 LPX441018 LPX441417 LPX441437 LPX441445 LPX441265 LPX441446 LPX441412 LPX441451 LPX441462 LPX441448 LPX441450 LPX441475 LPX441457 LPX441444 LPX490014 LPX441099 LPX441452
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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