NeuViz 128 Multi-slice CT Scanner System with software version 1 — Class II medical device recall Z-0876-2017
Terminated recall by Neusoft Medical Systems Co., Ltd., reported 2017-01-04. The Firm discovered during contrast agent tracking scan, when the expected concentration of contrast agent is
| Recall number | Z-0876-2017 |
|---|---|
| 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 | 2016-08-31 |
| Classified | 2016-12-23 |
| Reported by FDA | 2017-01-04 |
| Terminated | 2018-01-04 |
| Quantity | 23 units |
Product
NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version
Reason for recall
The Firm discovered during contrast agent tracking scan, when the expected concentration of contrast agent is reached, later planned scan may be interrupted. The system must be powered down and restarted to clear the interruption error before scanning can resume.
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-0876-2017. 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.