Recall Z-1281-2019 ยท JAK System, X-Ray, Tomography, Computed
Neusoft Medical Systems Co., Ltd.
NeuViz 16 Essence 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 p
| Date | Oct 22, 2018 |
| Status | Terminated |
| Reason | Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during scan, there will be some electromagnetic interference in the system which may affect the control signal of the flying focal spot, resulting in an incorrect flying focal spot sequence. If the system does not receive error, it would continue to complete the scan with the incorrect flying focal spot sequence, having an effect on the reconstruction of some images, resulting in image loss. |
| Root cause | Software design |
| Action | A customer notification letter will be sent to affected customers by email. All the affected systems will be corrected with the upgraded software in the field free of charge. |
| Quantity | 2 |
| Distribution | US Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171198 | NeuViz 16 Essence Multi-slice CT Scanner System Neusoft Medical Systems Co., Ltd., Dec 7, 2017 |