BEUDAMED
    FDA Enforcement Class II Terminated

    Siemens syngo.plaza radiological image processing system.

    Recall: Z-0048-2013 · Reported October 17, 2012

    Enforcement

    Recall Number
    Z-0048-2013
    Event ID
    63045
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 17, 2012
    Initiation Date
    June 6, 2012
    Classification Date
    October 11, 2012
    Termination Date
    April 13, 2013
    Address
    51 Valley Stream Pkwy, N/A, Malvern, PA, 19355, United States

    Description

    Siemens syngo.plaza radiological image processing system.

    Reason

    Siemens became aware of an unintended behavior when using syngo.plaza. In syngo.plaza within the online "Short Time Storage" (STS), some studies are marked with an archived icon, however, the entry in the Archive Database referring to the physical file may be missing.

    Code Info

    Model number 10592457, serial numbers 100263, 100401, 100177, 100138, 100174, 100406, 100249, 100201, 100198, 100181, 100146.

    Distribution

    Nationwide Distribution including the states of MO, FL, MA, NY, WI, GA, CA and WA.

    Quantity

    11