FDAMay 8, 2020device

uCT 530 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 a service function which may cause false marking of a bad channel resulting in ring artifacts, and potential intermittent scout scanning interruption due to occasional angle signal drift.. If these problems occur, it may be necessary to rescan the patient resulting in an additional dose of radiation and the possible need for additional contrast medium.

What to do

FDA enforcement status: Ongoing

Brands named

shanghai united imaging healthcareshanghaishanghai united

UPCs

6971576831012

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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uCT 530 Computed Tomography X-Ray System — Recall Details · AllClear