Medical device recalls Moderate risk

Neusoft Medical Systems Co., Ltd. recalls NeuViz 64 Multi-slice CT Scanner Systems

Recall date
August 31, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0875-2017
FDA classification
Class II
Brand / firm
Neusoft Medical Systems Co., Ltd.
Sold / distributed
US Distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

NeuViz 64 Multi-slice CT Scanner Systems

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