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 | 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. |
| Product | NeuViz 64 Multi-slice CT Scanner Systems |
| Quantity | 23 units |
| Distribution | US Distribution |
| Initiated | 2016-08-31 |
| Classified | 2016-12-23 |
| Terminated | 2018-01-04 |
| Recall number | Z-0875-2017 |
| 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-0875-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75383/
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