FDA Device recall Z-1693-2015
Neusoft NeuViz 64 Multi-slice CT Scanner System
- FDA Device
- Class II
- terminated
- Published 2015-06-24
On 2015-06-24 the FDA classified a Class II recall of Neusoft NeuViz 64 Multi-slice CT Scanner System by Neusoft Medical System, citing 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 degradat….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1693-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-08 |
| Published | 2015-06-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Neusoft Medical System |
| Distribution | IL, MA, PR, SC, TX |
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
Identifiers
| code_info | NeuViz 16/64 Series |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1693-2015%22
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