GE Healthcare, LLC recalls Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray…

Recall date

July 12, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0776-2019

FDA classification

Class II

Brand / firm

GE Healthcare, LLC

Sold / distributed

Worldwide Distribution - US (Nationwide Distribution) and countries of: Australia, Belgium, Canada, Estonia, Finland, France, Germany, Hong Kong, Ireland, Japan, Korea Republic of, Malaysia, Morocco, New Zealand, Norway, Saudi Arabia, Singapore, Slovakia, Sweden, Switzerland, Thailand, Turkey, Unit…

Why it was recalled

On the Revolution CT systems equipped with the SmartStep Option, the Z location displayed on image annotation and on the gantry display may not be the actual location of the table and result in the system scanning at a location that is not what was confirmed by the operator

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.