medical Class II Updated 2022-05-18

Shanghai United Imaging Healthcare Co., Ltd. recalls Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 5

Recalled Product

Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: DI/GTIN: 06971576833023, Serial Numbers: 270012, 270013,270014, 270015
View official government recall

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