Shanghai United Imaging Healthcare Co., Ltd. recalls Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 Intended use The uCT Computed Tomography X-ray S…

Recall date

May 23, 2020

Source

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

Recall number

Z-2641-2020

FDA classification

Class II

Brand / firm

Shanghai United Imaging Healthcare Co., Ltd.

Sold / distributed

US Distribution to state of: TX

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

Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 Intended use The uCT Computed Tomography X-ray System uCT 530/uCT 550 is a computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck and vascular).