Neusoft Medical System Co recalls Neusoft NeuViz 64 Multi-slice CT Scanner System

Recall date

March 8, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1693-2015

FDA classification

Class II

Brand / firm

Neusoft Medical System Co

Sold / distributed

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 T…

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Neusoft NeuViz 64 Multi-slice CT Scanner System