The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2587-2018·Announced 2018-08-08

GE Healthcare Recalls CT Systems with Potential Electrical Wiring Defect

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

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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. The hazard involves a potential electrical wiring defect in a medical device where no specific injuries or illnesses have been reported, fitting the criteria for a high-risk product where harm has not yet been reported.

Plain-English summary

GE Healthcare, LLC is recalling 42 units of the CT Goldseal BrightSpeed 16 PWR TIO 2 YR. The recall involves CT and CT/PET systems recently installed with a GE-supplied A! electrical panel. These systems may not be properly wired to the partial system uninterruptible power supply (UPS).

The affected units 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 specific unit identified in the recall notice has serial number 194800HM9 and System ID Number ALLIANCECT171.

This recall is classified as Class II by the FDA. The hazard involves a potential electrical wiring issue that could affect the functionality of the uninterruptible power supply. Healthcare facilities should contact GE Healthcare for instructions on how to resolve the wiring issue.

The recalled product

Product
CT Goldseal BrightSpeed 16 PWR TIO 2 YR
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)

  • Serial number 194800HM9
  • System ID Number ALLIANCECT171

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 →

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