NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)

Class I - Dangerous

🏥 Medical Devices Recalled: May 2, 2015 Neusoft Medical Systems Co. Diagnostic Equipment

What Should You Do?

Check if you have this product:
Serial Numbers: N64E120022E, N64E130039E, N64I130051E, N64E130062E, N64E130063E, N64E130066E, N64I140077E
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
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:: It was found by R&D in April, 2014 that there was a defect in NeuViz 64 system software version 1.0.5+P09. The icons of side decubitus didn't meet the patient position description, when the scanner position was set to "Right" in the system setting - scanner options.
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 System (consist if two variants: NeuViz 64e, NeuViz 64i)

Product Codes/Lot Numbers:

Serial Numbers: N64E120022E, N64E130039E, N64I130051E, N64E130062E, N64E130063E, N64E130066E, N64I140077E

Distribution:

Distributed in: US, IL, CT, SC, NE

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1650-2016

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