🔍 RecallPedia

NeuViz 64 Multi-slice CT Scanner Systems

Class I - Dangerous
🏥 Medical Devices Recalled: August 31, 2016 Neusoft Medical Systems Co. Diagnostic Equipment

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Neusoft Medical Systems Co., Ltd.
Reason for Recall:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

NeuViz 64 Multi-slice CT Scanner Systems

Product Codes/Lot Numbers:

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:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0875-2017

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Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during scan, there will be some electromagnetic interference in the system which may affect the control signal of the flying focal spot, resulting in an incorrect flying focal spot sequence. If the system does not receive error, it would continue to complete the scan with the incorrect flying focal spot sequence, having an effect on the reconstruction of some images, resulting in image loss.

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Neusoft Medical Systems Co.

Class I - Dangerous

Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during scan, there will be some electromagnetic interference in the system which may affect the control signal of the flying focal spot, resulting in an incorrect flying focal spot sequence. If the system does not receive error, it would continue to complete the scan with the incorrect flying focal spot sequence, having an effect on the reconstruction of some images, resulting in image loss.

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