Recall Z-0876-2017 ยท JAK System, X-Ray, Tomography, Computed
Neusoft Medical Systems Co., Ltd.
NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version
| Date | Aug 31, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | Neusoft Medical Systems Co. Ltd. planned action to bring into compliance. 1.Affected Customers will be notified by letter to provide them a description of the affected device, instructions for using the device prior to correction, hazards associated with the defect, and a statement of corrective actions to be taken at no cost to the owner. 2.Field Service Engineers will visit owner sites to install a software update which resolves the defect. 3.Corrections will be made at no cost to the owner 4.Corrections will be completed by May 11, 2017. CDRH approves the CAP subject to the following c |
| Quantity | 23 units |
| Distribution | US Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121792 | NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEM Neusoft Medical Systems Co., Ltd., Nov 16, 2012 |