Z-1693-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 24, 2015
- Initiation Date
- March 8, 2014
- Termination Date
- December 5, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 installed in US
Product Description
Neusoft NeuViz 64 Multi-slice CT Scanner System
Reason for Recall
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
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.
Code Information
NeuViz 16/64 Series