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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