The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2583-2018·Announced 2018-08-08

GE Healthcare Recalls CT Systems with Potential Electrical Wiring Defect

GE Healthcare is recalling 42 CT Goldseal Optima CT 600 systems because they 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 and involves a potential electrical wiring defect in a medical device, which poses a risk of harm if the power supply fails, but no injuries or illnesses have been reported.

Plain-English summary

GE Healthcare, LLC is recalling 42 units of the CT Goldseal Optima CT 600 system. The recall is due to a potential defect where the 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 51941YC3 and System ID Number 406434660.

This recall is classified as Class II by the U.S. Food and Drug Administration. Healthcare facilities should contact GE Healthcare to verify if their equipment is affected and to arrange for necessary repairs to ensure proper wiring to the UPS.

The recalled product

Product
CT Goldseal Optima CT 600
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Imaging Equipment
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 51941YC3
  • System ID Number 406434660

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

See all →

Same hazard · electrical wiring defect

See all →

Similar recalls