medical Class II Updated 2020-08-05

Shanghai United Imaging Healthcare Co., Ltd. recalls Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (

Recalled 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).


Hazard / Issue

The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: SN 300162, 300163, 300174, 300176
View official government recall

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