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Shanghai United Imaging Healthcare Co., Ltd. recalls Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
Recalled May 18, 2022 · FDA recall Z-1075-2022 · Shanghai United Imaging Healthcare
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. · FDA Class II
Units
4
Sold at
US Nationwide distribution in the state of TX.
Description
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.
Product
Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
Manufacturer(s)
Shanghai United Imaging Healthcare Co., Ltd.
Made in
China
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →