Neusoft NeuViz 64 Multi-slice CT Scanner System — Class II medical device recall Z-1693-2015
Terminated recall by Neusoft Medical System Co, reported 2015-06-24, distributed in IL, MA, PR, SC, TX. The A-plane compensator is made of Teflon which will become fragile due to X-ray exposure passing through it.
| Recall number | Z-1693-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Neusoft Medical System Co, Houston, TX, United States |
| Recall initiated | 2014-03-08 |
| Classified | 2015-06-16 |
| Reported by FDA | 2015-06-24 |
| Terminated | 2016-12-05 |
| Distributed | IL, MA, PR, SC, TX |
| Countries outside the US | AE, BR, CN, EC, EG, LB, MY, TN, ZA |
| Quantity | 5 installed |
| Reason classes | specification failure |
Product
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1693-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.