FDA-Device2021-03-10Class II
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.
Shanghai United Imaging Healthcare Co., Ltd.
Hazard
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.
Sold states
US Nationwide distribution in the state of TX.
Affected count
6 units
Manufactured in
No. 2258 Chengbei Rd, Jiading Ind., Shanghai, China
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1160-2021Don't want to check this manually?
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