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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