The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2580-2018·Announced 2018-08-08

GE Healthcare Recalls CT Systems With Potential Electrical Wiring Defect

GE Healthcare is recalling 42 Discovery MI CT systems installed with a specific electrical panel that may not be properly wired to the UPS.

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, and the hazard involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

GE Healthcare, LLC is recalling 42 units of Discovery MI CT and CT/PET systems, specifically labeled as Discovery DMI 15 cm 3 ring and Discovery DMI 20cm 4 ring. The recall involves systems recently installed with a GE-supplied A! electrical panel.

The recall is being conducted because these systems may not be properly wired to the partial system Uninterruptible Power Supply (UPS). This defect could affect the power stability of the medical equipment.

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. Healthcare facilities should contact GE Healthcare for instructions on how to resolve the wiring issue.

The recalled product

Product
Discovery MI, labeled as Discovery DMI 15 cm 3 ring, and Discovery DMI 20cm 4 ring
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 (3)

  • CJRPX1800017CN (561422MI)
  • CJRPX1800018CN (617726PET1EB)
  • CJRPX1800021CN (404616DMI)

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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