Recall Z-1650-2016 ยท JAK System, X-Ray, Tomography, Computed
Neusoft Medical Systems Co., Ltd.
NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)
| Date | May 2, 2015 |
| Status | Terminated |
| Reason | It was found by R&D in April, 2014 that there was a defect in NeuViz 64 system software version 1.0.5+P09. The icons of side decubitus didn't meet the patient position description, when the scanner position was set to "Right" in the system setting - scanner options. |
| Root cause | Device Design |
| Action | An upgraded software version (1.0.5.2619+P11) was released on May 7, 2015. The FCO was released to the service engineers of Neusoft Medical Systems USA, which is subsidiary of the reporting firm, and the engineers performed FCO for each affected device together with the distributors' engineers. The corrections (FCOs to upgrade software) on all the affected systems in the USA have been completed. At present (4/27/16) there is no longer this issue on the systems, so no further actions are needed for customers/distributors. However, the recalling firm shall inform the direct accounts of thi |
| Quantity | 7 units |
| Distribution | US Distribution - Including Puerto Rico and the states of IL, CT, SC, NE |
| 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 |