Recall Z-0550-2016 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
Syngo Imaging XS is a Picture Archiving and Communication System (PACS)
| Date | Nov 17, 2015 |
| Status | Terminated |
| Reason | For the Syngo Workflow SLR System with Software Ver: VB10C: Printouts may be printed in incorrect anatomical size when using 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 Imaging XS printer configuration file. |
| Root cause | Software in the Use Environment |
| Action | 11/17/2015, CSAN sent to customers with a list of suitable printers for the anatomical printing. |
| Quantity | 42 |
| Distribution | AL ; CA ; CO ; CT ; FL ; GA ; IA ; IL ; IN ; KS ; MD ; MI ; MO ; NC ; NE ; NJ ; NV ; NY ; OH ; PA ; TN ; TX ; WI ; |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082430 | SYNGO IMAGING XS Siemens AG Medical Solutions, Nov 14, 2008 |