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Shanghai United Imaging Healthcare Co., Ltd. recalls Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 - Product Usage: intended to produc
Recalled August 5, 2020 · FDA recall Z-2704-2020 · Shanghai United Imaging Healthcare
Hazard
The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge. · FDA Class II
Units
4
Sold at
US Nationwide distribution including in the states of CA, IN and TX. See uploaded distribution list for more details.
Description
The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.
Product
Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac, and vascular).
Manufacturer(s)
Shanghai United Imaging Healthcare Co., Ltd.
Made in
China
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →