Device product
Syngo Imaging XS is a Picture Archiving and Communication System (PACS)
Z-0550-2016
Product summary
- Event
- Event 72838
- Status
- Terminated
- Classification
- Class II
- Quantity
- 42
- Official record key
device-enforcement:Z-0550-2016
Official wording
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.
Code information: Model number 10558586 Software version VB10C
Distribution pattern: AL ; CA ; CO ; CT ; FL ; GA ; IA ; IL ; IN ; KS ; MD ; MI ; MO ; NC ; NE ; NJ ; NV ; NY ; OH ; PA ; TN ; TX ; WI ;
Derived failure modes
-
Device software or design
Software Ver: VB10C: Printouts may be printed in incorrect