FDAMay 8, 2020device
uCT 760 System, Computed Tomography X-ray System
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Two issues were identified with the computed tomography x-ray system including an intermittent issue which may affect image data leading to artifacts; and intermittent scout scanning interruption due to occasional angle signal drift. This may result in the need for rescanning of the patient with the patient receiving an additional dose of radiation and possible use of additional contrast media.
What to do
FDA enforcement status: Terminated
Brands named
shanghai united imaging healthcareshanghaishanghai united
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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