Neusoft NeuViz 64 Multi-slice CT Scanner System recall: Impurity Out of Spec
Neusoft NeuViz 64 Multi-slice CT Scanner System
Why was Neusoft NeuViz 64 Multi-slice CT Scanner System 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
NeuViz 16/64 Series
- Product
- Neusoft NeuViz 64 Multi-slice CT Scanner System
- Recalling firm
- Neusoft Medical System Co
- Quantity
- 5 installed in US
- Distribution
- 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.
- Recall date
- June 24, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)