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Recall Observatory FDA recall evidence

Device product

NeuViz 64 Multi-slice CT Scanner Systems

Z-0875-2017

August 31, 2016

Class II

Product summary

Firm
Neusoft Medical Systems Co., Ltd.
Event
Event 75383
Status
Terminated
Classification
Class II
Quantity
23 units
Official record key
device-enforcement:Z-0875-2017

Official wording

Reason: 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.

Code information: 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

Distribution pattern: US Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.