BEUDAMED
    FDA Enforcement Class II Terminated

    Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image Processing System

    Recall: Z-0465-2013 · Reported December 12, 2012

    Enforcement

    Recall Number
    Z-0465-2013
    Event ID
    63521
    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 12, 2012
    Initiation Date
    June 20, 2012
    Classification Date
    December 3, 2012
    Termination Date
    January 14, 2014
    Address
    51 Valley Stream Pkwy, N/A, Malvern, PA, 19355, United States

    Description

    Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image Processing System

    Reason

    Firm has become aware of an unintended behavior when using syngo.plaza and issued an Update Instruction. The Update Instruction SY050/12/S provides a software update and addresses the following issues: - Patient Rename messages for the same patient are being continually processed for several days. This fills up the 'pcvdbsrv' log and potentially affects performance of the system. - Data could

    Code Info

    Model number 10 592 457

    Distribution

    Nationwide distribution: USA including states of: CA, FL, GA, MA, MN, MO, NJ, NY, OH, and WI.

    Quantity

    15