FDA Device recall Z-3044-2017
Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previou…
- FDA Device
- Class II
- terminated
- Published 2017-09-06
On 2017-09-06 the FDA classified a Class II recall of Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previou… by Neusoft Medical Systems, citing software defect.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3044-2017 |
| 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 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 taken at different angles.
Reason
Software defect
Identifiers
| code_info | NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11…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 |
|---|
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-3044-2017%22
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