Recall Z-1693-2015— Neusoft Medical System Co
Class II · Terminated
Class II FDA medical device recall by Neusoft Medical System Co, initiated 2014-03-08, terminated 2016-12-05. It names one FDA 510(k) clearance: K121792. Product: Neusoft NeuViz 64 Multi-slice CT Scanner System. 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.
- Recalling firm
- Neusoft Medical System Co
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-03-08
- Terminated
- 2016-12-05
- Firm location
- Houston, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.