Shanghai United Imaging Healthcare Co., Ltd. recalls Digitial Medica X-ray Imagining System, Model: uDR 596i, RX,
Recalled Product
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.
Hazard / Issue
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.
Issued by
FDA
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