Shanghai United Imaging Healthcare Co., Ltd. recalls Computed Tomography X-Ray System, Model uCT 530, Rx, CE, GTI
Recalled Product
Computed Tomography X-Ray System, Model uCT 530, Rx, CE, GTIN: 06971576831012 - 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).
Hazard / Issue
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.
Issued by
FDA
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