FDA-Device2015-12-30Class II

Syngo Imaging XS is a Picture Archiving and Communication System (PACS)

Siemens Medical Solutions USA, Inc
Hazard

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.

Sold states
AL ; CA ; CO ; CT ; FL ; GA ; IA ; IL ; IN ; KS ; MD ; MI ; MO ; NC ; NE ; NJ ; NV ; NY ; OH ; PA ; TN ; TX ; WI ;
Affected count
42
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Syngo Imaging XS is a Picture Archiving and Communication System (PACS)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0550-2016

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