medical Class II Updated 2020-11-18

Shanghai United Imaging Healthcare Co., Ltd. recalls Computed Tomography X-Ray System, Model uCT 760, Rx, CE, GTI

Recalled Product

Computed Tomography X-Ray System, Model uCT 760, Rx, CE, GTIN: 06971576831043 - 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

Distribution: Nationwide (United States)
Lot/Code Info: Serial Numbers: 600229, 600230, 600232, 600271, 600282
View official government recall

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