NeuViz 128 Multi-slice CT Scanner System with software version 1 — Class II medical device recall Z-0773-2019
Terminated recall by NEUSOFT MEDICAL SYSTEMS IMP & EX, reported 2019-02-13, distributed in KS, MA, OK. For surview scan length more than 500mm,if the user aborts or skips the reconstructed surview, the image may h
| Recall number | Z-0773-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA mandated |
| Recalling firm | NEUSOFT MEDICAL SYSTEMS IMP & EX, Shenyang, China |
| Recall initiated | 2019-01-09 |
| Classified | 2019-02-05 |
| Reported by FDA | 2019-02-13 |
| Terminated | 2022-08-25 |
| Distributed | KS, MA, OK |
| Quantity | 3 |
Product
NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 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
For surview scan length more than 500mm,if the user aborts or skips the reconstructed surview, the image may have the wrong field of view (FOV). When user plans and performs subsequent clinical scan with the wrong FOV the actual start and end position may not be consistent with the planned positons.
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-0773-2019. 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.