Neusoft Medical Systems Co., Ltd. recalls NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)
- Recall date
- May 2, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1650-2016
- FDA classification
- Class II
- Brand / firm
- Neusoft Medical Systems Co., Ltd.
- Sold / distributed
- US Distribution - Including Puerto Rico and the states of IL, CT, SC, NE
Why it was recalled
It was found by R&D in April, 2014 that there was a defect in NeuViz 64 system software version 1.0.5+P09. The icons of side decubitus didn't meet the patient position description, when the scanner position was set to "Right" in the system setting - scanner options.
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 System (consist if two variants: NeuViz 64e, NeuViz 64i)
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