FDA-Device2017-01-04Class II
NeuViz 64 Multi-slice CT Scanner Systems
Neusoft Medical Systems Co., Ltd.
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.
Sold states
US Distribution
Affected count
23 units
Manufactured in
NO. 16 Shiji Road, Hunnan Industrial Area, Shenyang, N/A, China
Products
NeuViz 64 Multi-slice CT Scanner Systems
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0875-2017Don't want to check this manually?
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