Neusoft Medical NeuViz 64 Multi-slice CT Scanner System — Class II medical device recall Z-3044-2017
Terminated recall by Neusoft Medical Systems Co., Ltd., reported 2017-09-06, distributed nationwide. Software defect
| Recall number | Z-3044-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Neusoft Medical Systems Co., Ltd., Shenyang, N/A, China |
| Recall initiated | 2017-05-19 |
| Classified | 2017-08-28 |
| Reported by FDA | 2017-09-06 |
| Terminated | 2020-11-19 |
| Distributed | Nationwide (US) |
| Quantity | 234 |
| Reason classes | software |
Product
Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P11 or previous version Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.
Reason for recall
Software defect
Machine access
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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.