Recall Z-0576-2015 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS : Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.
| Date | Dec 15, 2014 (initiated Nov 11, 2014) |
| Status | Terminated |
| Reason | Printouts may be printed in incorrect anatomical size when using syngo.plaza or syngo Imaging XS filming application in conjunction with a printer not released for anatomical print usage. This may happen due to an invalid combination of printer and the syngo.plaza printer configuration file. Printouts in anatomical size are not correct and may influence diagnostic decisions and/or therapy. |
| Root cause | Component design/selection |
| Action | Siemens sent a Safety Advisory notices letter dated November 11, 2014 to affected customers. The letter identified the affected product, problem, and actions to be taken. For questions call 1-888-826-9702. |
| Quantity | 149 |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |