FDA-Device2020-07-15Class II
uDR 596i Digital Medical X-Ray Imaging System - Product Usage: intended to use 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.
Shanghai United Imaging Healthcare Co., Ltd.
Hazard
Two issues were identified with the stationary x-ray system. 1. Some position illustrations in the patient exam interface show the incorrect anatomical position for the standard of care. When the image is acquired with the wrong reference position, clinical diagnostic requirements cannot be met.T2. Where image stitching is used, the left and right tag information may be lost. When these problems are encountered, an additional exposure is needed and the patient will receive more radiation.
Sold states
US Nationwide distribution including in the state of Texas.
Affected count
6 units
Manufactured in
No. 2258 Chengbei Rd, Jiading Ind., Shanghai, China
Products
uDR 596i Digital Medical X-Ray Imaging System - Product Usage: intended to use 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2521-2020Don't want to check this manually?
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