FDA-Device2015-06-24Class II
Neusoft NeuViz 64 Multi-slice CT Scanner System
Neusoft Medical System Co
Hazard
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
Sold states
Worldwide Distribution - US Distribution including Puerto Rico and to the states of : IL, MA, TX and SC., and to the countries of : China, Malaysia, Lebanon, Ecuador, Egypt, United Arab Emirates,Kazashstan, Tunisia, Angola, Brazil, Uzbekistan, Lebanon, Cote D' ivoire, South Africa, Montenegro and Tajikistan.
Affected count
5 installed in US
Manufactured in
14425 Torrey Chase Blvd Ste 100, Houston, TX, United States
Products
Neusoft NeuViz 64 Multi-slice CT Scanner System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1693-2015Don't want to check this manually?
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