NeuViz 64 Multi-slice CT Scanner System Product Usage: The… — Class II medical device recall Z-1279-2019
Terminated recall by Neusoft Medical Systems Co., Ltd., reported 2019-05-29, distributed nationwide. Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during s
| Recall number | Z-1279-2019 |
|---|---|
| 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 | 2018-10-22 |
| Classified | 2019-05-21 |
| Reported by FDA | 2019-05-29 |
| Terminated | 2022-08-25 |
| Distributed | Nationwide (US) |
| Quantity | 37 |
| Reason classes | software |
Product
NeuViz 64 Multi-slice CT Scanner System 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: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during scan, there will be some electromagnetic interference in the system which may affect the control signal of the flying focal spot, resulting in an incorrect flying focal spot sequence. If the system does not receive error, it would continue to complete the scan with the incorrect flying focal spot sequence, having an effect on the reconstruction of some images, resulting in image loss.
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-1279-2019. 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.