FDA Device recall Z-0875-2017
NeuViz 64 Multi-slice CT Scanner Systems
- FDA Device
- Class II
- terminated
- Published 2017-01-04
On 2017-01-04 the FDA classified a Class II recall of NeuViz 64 Multi-slice CT Scanner Systems by Neusoft Medical Systems, citing 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 po….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0875-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-08-31 |
| Published | 2017-01-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Neusoft Medical Systems |
| Distribution | n/a |
Product
NeuViz 64 Multi-slice CT Scanner Systems
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.
Identifiers
| code_info | NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P04 or previous version. NeuViz 64En, NeuViz 641n with soft…NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P04 or previous version. NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P05 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-0875-2017%22
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