Shanghai United Imaging Healthcare Co., Ltd. recalls Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Product Usage: intended…

Recall date

January 25, 2021

Source

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

Recall number

Z-1160-2021

FDA classification

Class II

Brand / firm

Shanghai United Imaging Healthcare Co., Ltd.

Sold / distributed

US Nationwide distribution in the state of TX.

Why it was recalled

There is a potential for the X-Ray tube head (Touch screen interface) to perform an uncommanded motion. This could result in a collision with the patient.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Product Usage: intended to used by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk. Not for mammography.