BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0550-2016 · Reported December 30, 2015

    Enforcement

    Recall Number
    Z-0550-2016
    Event ID
    72838
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 30, 2015
    Initiation Date
    November 17, 2015
    Classification Date
    December 24, 2015
    Termination Date
    December 5, 2016
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    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.

    Code Info

    Model number 10558586 Software version VB10C

    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