NeuViz 64 Multi-Slice CT Scanner System — Class II medical device recall Z-1650-2016
Terminated recall by Neusoft Medical Systems Co., Ltd., reported 2016-05-18, distributed in CT, IL, NE, PR, SC. It was found by R&D in April, 2014 that there was a defect in NeuViz 64 system software version 1.0.5+P09. The
| Recall number | Z-1650-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Neusoft Medical Systems Co., Ltd., Shenyang, N/A, China |
| Recall initiated | 2015-05-02 |
| Classified | 2016-05-11 |
| Reported by FDA | 2016-05-18 |
| Terminated | 2016-11-04 |
| Distributed | CT, IL, NE, PR, SC |
| Quantity | 7 units |
| Reason classes | software |
| Serial numbers | N64E120022E, N64E130039E, N64E130062E, N64E130063E, N64E130066E, N64I130051E, N64I140077E |
Product
NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)
Reason for recall
It was found by R&D in April, 2014 that there was a defect in NeuViz 64 system software version 1.0.5+P09. The icons of side decubitus didn't meet the patient position description, when the scanner position was set to "Right" in the system setting - scanner options.
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-1650-2016. 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.