FDA-Device2022-05-18Class II
Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
Shanghai United Imaging Healthcare Co., Ltd.
Hazard
X-ray imaging system positioning image and protocol label is reversed for Flexion and Extension on C-Spine and L-Spine, this will cause the image to be incorrectly labeled and may cause the patient to have a repeat exposure.
Sold states
US Nationwide distribution in the state of TX.
Affected count
4
Manufactured in
No. 2258 Chengbei Rd, Jiading Ind., N/A, Shanghai, N/A, China
Products
Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1075-2022Don't want to check this manually?
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