BEUDAMED
    FDA Enforcement Class II Terminated

    Siemens syngo.plaza image processing system image processing radiological system

    Recall: Z-0271-2014 · Reported November 20, 2013

    Enforcement

    Recall Number
    Z-0271-2014
    Event ID
    65792
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 20, 2013
    Initiation Date
    August 8, 2011
    Classification Date
    November 13, 2013
    Termination Date
    November 6, 2014
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355, United States

    Description

    Siemens syngo.plaza image processing system image processing radiological system

    Reason

    The firm became aware of an unintended behavior when using the syngo.plaza. The "Rename" functionality can cause an unintended patient merge if the patient is sent to another system. This issue affects customers who transfer patient data between two or more syngo.plaza or syngo Imaging XS systems.

    Code Info

    Model Number 10592457 with serial numbers 100263, 100177, 100138, 100174, 100005, 100006, 100007, 100008, 100009, 100010, 100219, 100201, 100198, 100181, 100249, 100301, 100302, 100157, 100146

    Distribution

    Nationwide Distribution including MO, MA, NY, WI, OH, NY, CA, FL, NC, MN, and WA.

    Quantity

    19