FDAJuly 30, 2019device
Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
shanghai united imaging healthcareshanghaishanghai united
UPCs
06971576833023
Recall history
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