Shanghai United Imaging Healthcare Co., Ltd. recalls uCT 760 System, Computed Tomography X-ray System

Recall date

May 8, 2020

Source

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

Recall number

Z-2522-2020

FDA classification

Class II

Brand / firm

Shanghai United Imaging Healthcare Co., Ltd.

Sold / distributed

Distributed to two customers. Both customers located in Houston, Texas.

Why it was recalled

Two issues were identified with the computed tomography x-ray system including an intermittent issue which may affect image data leading to artifacts; and intermittent scout scanning interruption due to occasional angle signal drift. This may result in the need for rescanning of the patient with the patient receiving an additional dose of radiation and possible use of additional contrast media.

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

What was recalled

uCT 760 System, Computed Tomography X-ray System