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Recall Observatory FDA recall evidence

Device product

Neusoft NeuViz 64 Multi-slice CT Scanner System

Z-1693-2015

March 08, 2014

Class II

Product summary

Firm
Neusoft Medical System Co
Event
Event 71306
Status
Terminated
Classification
Class II
Quantity
5 installed in US
Official record key
device-enforcement:Z-1693-2015

Official wording

Reason: 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

Code information: NeuViz 16/64 Series

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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