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Recall Observatory FDA recall evidence

Device product

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

Z-0550-2016

November 17, 2015

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
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

    reason.device_software_design · v1.0.0

    Software Ver: VB10C: Printouts may be printed in incorrect