BEUDAMED
    FDA Recall Terminated

    Syngo Imaging XS model number 10496279 The intended use: image processing radiological

    Recall: Z-1423-2010 · Initiated February 16, 2010

    Recall

    Recall Number
    Z-1423-2010
    Event Number
    55108
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 16, 2010
    Posted
    April 20, 2010
    Terminated
    July 5, 2012
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    Description

    Syngo Imaging XS model number 10496279 The intended use: image processing radiological

    Reason

    images can be overwritten

    Action

    A "Customer (Safety) Advisory notice" dated February 16, 2010, was sent all affected customers via Update Instructions IM019/10/S. This notice describes the product, problem and the action to be taken by the customers. The customers should immediately instruct their employees of the advisor notice and maintain awareness. If the customer sold the device/equipment and is no longer in possession of it, they should forward the notice and inform Siemens of the new owner. A software update to correct this issue will be distributed and installed by a Siemens Service Engineer on all affected systems under Update Instructions IM020/10/S. If you have any further questions regarding this issue, do not hesitate to contact your local SIEMENS Uptime Service Center ([email protected]).

    Distribution

    Nationwide distribution: CA, NC, NY, PA, and TX

    Quantity

    6 units