medical Class II Updated 2021-03-10

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

Distribution: Nationwide (United States)
Lot/Code Info: Serial Number: 270012, 270013, 270014, 270015, 270016, 270017
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →