The Recall Desk
HighFDA (Devices)·Z-1188-2013·Announced 2013-05-08

GE Healthcare Recalls CT Scanners Due to Heat Exchanger Bolt Defect

GE Healthcare is recalling 166 CT scanners because improperly torqued heat exchanger bolts may cause parts to detach and spill oil.

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

Plain-English summary

GE Healthcare, LLC is recalling 166 units of VCT for Discovery VCT, Discovery RX VCT, Discovery PET/CT 690, Lightspeed VCT, and Discovery CT750HD. These devices are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission.

The recall is due to fastener bolts on the heat exchanger that were not properly torqued. This defect can cause part of the heat exchanger to detach from the gantry and hit the inside of the covers and other components. This impact may result in the oil conduit breaking, causing oil to spill within the gantry and outside the system.

The affected units were distributed nationwide in the United States, including DC and 28 states, as well as in 35 countries worldwide. No injuries or illnesses have been reported in the source text. Users should contact GE Healthcare for instructions on how to resolve the issue.

The recalled product

Product
GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Discovery CT750HD. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission.
Manufacturer
GE Healthcare, LLC
Affected units
166

Distribution

Distributed nationwide across the United States.

The notice also names 29 states specifically: