The Recall Desk
HighFDA (Devices)·Z-1915-2016·Announced 2016-06-15

GE Revolution CT Patient Table Recalled for Unintended Motion Risk

GE Healthcare is recalling Revolution CT Patient Tables because the cradle can descend on its own, posing a crushing risk to large patients.

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 (crushing injury) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.

Plain-English summary

GE Healthcare, LLC is recalling the Revolution CT Patient Table due to a potential safety issue involving unintended motion. The system is intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications.

The recall is being issued because the Revolution CT cradle can descend on its own after activation by the user, specifically in cases involving large patients. This unintended motion can put the patient at risk for harm, including the impinging or crushing of a hand if caught between the cradle and the CT inner gantry bore.

A total of 197 units are affected, with 68 units distributed in the United States and 129 units distributed outside the US. The affected units were distributed nationwide in the US and in various countries including Australia, Canada, China, France, Germany, Japan, and the United Kingdom. The source text does not report any injuries or illnesses associated with this defect.

The recalled product

Product
GE Revolution CT The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial
Manufacturer
GE Healthcare, LLC

Distribution

Distributed nationwide across the United States.

The notice also names 20 states specifically: