FDAFDA · Food and drugs·Recall number Z-0875-2017
NeuViz 64 Multi-slice CT Scanner Systems
Published January 4, 2017 · Recall initiated: August 31, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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 Mandated · Letter
Recall details
- Manufacturer
- Neusoft Medical Systems Co., Ltd.
- Distributor
- US Distribution
- Lot
- NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P04 or previous version. NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P05 or previous version
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- China
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