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Neusoft Medical System Co recalls Neusoft NeuViz 64 Multi-slice CT Scanner System
Recalled June 24, 2015 · FDA recall Z-1693-2015 · Neusoft Medical System
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 · FDA Class II
Units
5 installed in US
Sold at
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.
Description
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
Product
Neusoft NeuViz 64 Multi-slice CT Scanner System
Manufacturer(s)
Neusoft Medical System Co
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →