Recall Z-1573-2016 ยท JAK System, X-Ray, Tomography, Computed
Philips and Neusoft Medical Systems Co., Ltd.
NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously.
| Date | Apr 27, 2016 (initiated Mar 24, 2016) |
| Status | Terminated |
| Reason | The following issues are found in NeuViz 16 systems with software version 1.1.4.21425 and version 1.1.4.21426: 1) During the filming operation on MX 16-slice console software, the clipboard used for copying and pasting images is not cleared between patients. If the operator fails to copy the current patient's images before pasting, a previous patient's image may be present in the clipboard and be |
| Root cause | Under Investigation by firm |
| Action | Affected consignees will be notified of the recall via letter on March 24, 2016. Mandatory Field Change Order and FCO kits will be released to all affected systems in June, 2016. |
| Quantity | 37 units |
| Distribution | NC, OH, NE, SC, TX, LA, PR, MO, FL, CT |
| FDA record | Open on fda.gov |