Device product
Neusoft NeuViz 64 Multi-slice CT Scanner System
Z-1693-2015
Product summary
- 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
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