Recall Z-3045-2017 ยท JAK System, X-Ray, Tomography, Computed
Neusoft Medical Systems Co., Ltd.
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 sp
| Date | May 19, 2017 |
| Status | Terminated |
| Reason | Software defect |
| Root cause | Software design |
| Action | Neusoft Medical Systems will bring defect into compliance: The defect will be remedied by updating software. Field Change Order I related to software updated will be released to the affected systems in ' Aug, 2017. The affected systems will be upgraded with updated software in the field free of char e in 6 months after the FCO release. |
| Quantity | 154 |
| Distribution | US Nationwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151383 | NeuViz 128 Multi-slice CT Scanner System Neusoft Medical Systems Co., Ltd., Nov 4, 2015 |