Recall Z-3044-2017 ยท JAK System, X-Ray, Tomography, Computed
Neusoft Medical Systems Co., Ltd.
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 an
| 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 | 234 |
| Distribution | US Nationwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.