Reported May 18, 2016 · Terminated

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

Neusoft Medical Systems Co., Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Neusoft Medical Systems Co., Ltd. · NO. 16 Shiji Road · Shenyang, N/A · N/A

Is this the product you have?

  • NeuViz 64 Multi-Slice CT
  • Scanner System (consist if two variants
    • NeuViz 64e
    • NeuViz 64i)
Lot codes and dates
  • Serial Numbers
    • N64E120022E
    • N64E130039E
    • N64I130051E
    • N64E130062E
    • N64E130063E
    • N64E130066E
    • N64I140077E
Amount recalled
7 units

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 4, 2016 · Data as of Sep 19, 6:01 PM UTC

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