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: 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. |
| 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. |
| Quantity | 37 |
| Distribution | US Nationwide Distribution. |
| Initiated | 2018-10-22 |
| Classified | 2019-05-21 |
| Terminated | 2022-08-25 |
| Recall number | Z-1279-2019 |
| 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-1279-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82753/
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