Device 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.
Z-3045-2017
Product summary
- Event
- Event 77608
- Status
- Terminated
- Classification
- Class II
- Quantity
- 154
- Official record key
device-enforcement:Z-3045-2017
Official wording
Reason: Software defect
Code information: NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P16 or previous version
Distribution pattern: US Nationwide distribution
Derived failure modes
-
Device software or design
Software defect