BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0550-2016 · Initiated November 17, 2015

    Recall

    Recall Number
    Z-0550-2016
    Event Number
    72838
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software in the Use Environment
    Initiated
    November 17, 2015
    Terminated
    December 5, 2016
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

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

    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.

    Action

    11/17/2015, CSAN sent to customers with a list of suitable printers for the anatomical printing.

    Distribution

    AL ; CA ; CO ; CT ; FL ; GA ; IA ; IL ; IN ; KS ; MD ; MI ; MO ; NC ; NE ; NJ ; NV ; NY ; OH ; PA ; TN ; TX ; WI ;

    Quantity

    42