FDA Device recall Z-3045-2017
Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomo…
- FDA Device
- Class II
- terminated
- Published 2017-09-06
On 2017-09-06 the FDA classified a Class II recall of Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomo… by Neusoft Medical Systems, citing software defect.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3045-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-05-19 |
| Published | 2017-09-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Neusoft Medical Systems |
| Distribution | US |
Product
Neusoft NeuViz 128 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
Software defect
Identifiers
| code_info | NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P16 or previous version |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3045-2017%22
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