FDAAugust 31, 2016device

NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The Firm discovered during contrast agent tracking scan, when the expected concentration of contrast agent is reached, later planned scan may be interrupted. The system must be powered down and restarted to clear the interruption error before scanning can resume.

What to do

FDA enforcement status: Terminated

Brands named

neusoft medical systemsneusoftneusoft medical

Recall history

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

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