The Recall Desk
HighFDA (Devices)·Z-1951-2019·Announced 2019-07-24

GE Healthcare Recalls Revolution CT Scanners Due to Radiation Exposure

GE Healthcare is recalling Revolution CT scanners because they may expose patients to additional low-dose radiation.

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 (radiation exposure) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.

Plain-English summary

GE Healthcare, LLC is recalling Revolution CT scanners. These systems are intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications. The recall involves 857 units, with 195 located in the United States and 662 outside the US.

The recall was initiated because the devices may result in additional low-dose radiation exposure. The source text does not specify the exact mechanism of the exposure or the magnitude of the dose increase.

The recall has worldwide distribution, including nationwide distribution in the US. The source text does not provide specific instructions for consumers or healthcare providers on how to manage the recall or mitigate the risk.

The recalled product

Product
Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Manufacturer
GE Healthcare, LLC

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 (1)

  • Revolution CT

Distribution

Distributed nationwide across the United States.