Computed Tomography X-ray System recalled over laceration hazard

Recall date

June 20, 2020

Source

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

Official notice title

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…

Recall number

Z-2704-2020

FDA classification

Class II

Brand / firm

Shanghai United Imaging Healthcare Co., Ltd.

Sold / distributed

US Nationwide distribution including in the states of CA, IN and TX. See uploaded distribution list for more details.

Why it was recalled

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

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 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).