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 | 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. |
| Product | NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i) |
| Quantity | 7 units |
| Distribution | US Distribution - Including Puerto Rico and the states of IL, CT, SC, NE |
| Initiated | 2015-05-02 |
| Classified | 2016-05-11 |
| Terminated | 2016-11-04 |
| Recall number | Z-1650-2016 |
| Initiation | Voluntary: Firm initiated |
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-1650-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73832/
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