Class II — Neusoft Medical Systems Co., Ltd.
| Recalling firm | NEUSOFT MEDICAL SYSTEMS CO., LTD. |
|---|---|
| Registered facility | NEUSOFT MEDICAL SYSTEMS CO., LTD. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Software defect |
| 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 … |
| Quantity | 234 |
| Distribution | US Nationwide distribution |
| Initiated | 2017-05-19 |
| Classified | 2017-08-28 |
| Terminated | 2020-11-19 |
| Recall number | Z-3044-2017 |
| Initiation | FDA Mandated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Neusoft Medical Systems Co., Ltd. (Z-3044-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77608/
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