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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Neusoft Medical Systems Co., Ltd.: 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.

Agency Publication Date: December 23, 2016
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Affected Products

Product: NeuViz 64 Multi-slice CT Scanner Systems

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

Product: NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version

NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 75383
Status: Resolved
Manufacturer: Neusoft Medical Systems Co., Ltd.
Manufactured In: China
Units Affected: 2 products (23 units)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.