Shanghai United Imaging Healthcare Co., Ltd. recalls Computed Tomography X-Ray System, Model uCT 550, Rx, CE, GTIN: 06971576831036 - Product Usage: ntended to produce cross…

Recall date

August 5, 2020

Source

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

Recall number

Z-0446-2021

FDA classification

Class II

Brand / firm

Shanghai United Imaging Healthcare Co., Ltd.

Sold / distributed

US Nationwide distribution including in the state of TX.

Why it was recalled

A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.

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, Rx, CE, GTIN: 06971576831036 - Product Usage: ntended 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, vascular).