Shanghai United Imaging Healthcare Co., Ltd. recalls uCT 530 Computed Tomography X-Ray System

Recall date

May 8, 2020

Source

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

Recall number

Z-2472-2020

FDA classification

Class II

Brand / firm

Shanghai United Imaging Healthcare Co., Ltd.

Sold / distributed

Distributed to Texas.

Why it was recalled

Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in ring artifacts, and potential intermittent scout scanning interruption due to occasional angle signal drift.. If these problems occur, it may be necessary to rescan the patient resulting in an additional dose of radiation and the possible need for additional contrast medium.

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 530 Computed Tomography X-Ray System