The Recall Desk
HighFDA (Devices)·Z-2578-2018·Announced 2018-08-08

GE Healthcare Recalls CT Systems with Potential UPS Wiring Defect

GE Healthcare is recalling 42 Discovery IQ 2.0 CT systems installed with a specific electrical panel that may not be properly wired to the uninterruptible power supply.

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: The recall is classified as FDA Class II, and the hazard involves a potential power supply wiring defect in a medical device where no injuries have been reported, fitting the criteria for a risk-of-harm product without reported injury.

Plain-English summary

GE Healthcare, LLC is recalling 42 Discovery IQ 2.0 20cm, 4 ring CT systems (Model Number 5432539-22). The recall involves specific serial numbers 502674HM5 and 504305HM4. These devices were distributed nationwide to facilities in Alabama, California, Colorado, Florida, Illinois, Indiana, Massachusetts, Maryland, Michigan, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, South Carolina, Tennessee, Texas, and Virginia.

The recall is due to a potential wiring defect. Some of these systems, recently installed with a GE-supplied A! electrical panel, may not be properly wired to the partial system uninterruptible power supply (UPS). This issue could affect the power stability of the equipment.

Healthcare facilities that have installed these specific CT systems should contact GE Healthcare to verify the wiring configuration and address any necessary corrections. The source text does not report any injuries or illnesses associated with this defect.

The recalled product

Product
Discovery IQ 2.0 20cm, 4 ring, Model Number 5432539-22
Manufacturer
GE Healthcare, LLC
Category
Medical Device — CT Scanner
Hazard
Affected units
42

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 (2)

  • Model Number 5432539-22. Serial Number 502674HM5 (System ID Number 510204DISCIQ)
  • Serial Number 504305HM4 (System ID Number 219922PTIQ)

Distribution

Distributed nationwide across the United States.

The notice also names 19 states specifically:

Part of a larger recall action

This product is one of 10 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

Related recalls

Same manufacturer · GE Healthcare, LLC

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Same hazard · electrical wiring

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