Reported Jun 24, 2015 · Terminated

Neusoft NeuViz 64 Multi-slice CT Scanner System

Neusoft Medical System Co.

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 System Co · 14425 Torrey Chase Blvd Ste 100 · Houston, TX · 77014-1637

Is this the product you have?

  • Neusoft NeuViz 64 Multi-slice CT Scanner System
Lot codes and dates
  • NeuViz 16/64 Series
Amount recalled
5 installed in US

Where it was sold

Why it was recalled

The A-plane compensator is made of Teflon which will become fragile due to X-ray exposure passing through it. The thinnest part of the compensator is subject to radiation degradation and as a result has been found to fail prematurely. Failure is indicated by pin or ring artifact in the image

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

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 5, 2016 · Data as of Sep 19, 6:16 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.