The Recall Desk
HighFDA (Devices)·Z-0157-2026·Announced 2025-10-22

GE LOGIQ P9 Ultrasound System Software Displays Inaccurate Liver Steatosis Measurements

GE Medical Systems is recalling 37 LOGIQ P9 R4.5 ultrasound systems because the UGAP measurement feature may display inaccurate values for liver steatosis, potentially leading to inappropriate clinical decisions.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is inaccurate diagnostic data that could lead to inappropriate clinical decisions, constituting a risk-of-harm product where injury has not yet been reported.

Plain-English summary

GE Medical Systems, LLC is recalling the LOGIQ P9 R4.5 ultrasound system (Model 5877533, system software version R4.5.7). This Class II recall affects 37 units of the affected product.

The Ultrasound-Guided Attenuation Parameter (UGAP) measurement feature may display inaccurate values representing liver steatosis. These inaccurate measurements could potentially lead to inappropriate clinical decisions that impact overall patient care.

The affected systems were distributed nationwide in the United States and globally. Healthcare providers and facilities using these systems should be aware of this defect in the UGAP measurement feature.

The recalled product

Product
LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — Diagnostic Ultrasound System
Hazard
  • measurement-inaccuracy
  • diagnostic-error
  • software-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Model 5877533 UDI-DI: 00195278464637

Distribution

Distributed nationwide across the United States.

Related recalls

Same category