Recall Z-2235-2008 ยท JAK System, X-Ray, Tomography, Computed
Philips And Neusoft Medical Systems Co., Ltd.
NeuViz Dual series computed Tomography Scanner System, X-Ray System The CT scanner is a whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle.
| Date | Sep 17, 2008 (initiated Dec 17, 2007) |
| Status | Terminated |
| Reason | Labeling of patient position on scanned image does not match actual patient orientation. |
| Root cause | Software design |
| Action | On 12/17/08 the distributor sent a letter dated 12/13/07 to their customers explaining the problem and under what circumstances it can occur, the actions that should be taken by the customer/user in order to prevent risks for patients or users, and that the customer/user will be contacted for scheduling of a software upgrade by the distributor. Contact NEUISYS Service Support Department at 1-877-299-9052 for assistance. |
| Quantity | 15 units |
| Distribution | Distribution in US: CO, FL, KY, NC, SC, TN, and TX. |
| FDA record | Open on fda.gov |