FDA Device recall Z-0876-2017
NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version
- FDA Device
- Class II
- terminated
- Published 2017-01-04
On 2017-01-04 the FDA classified a Class II recall of NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version 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-0876-2017 |
| 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 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version
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 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 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-0876-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.