BEUDAMED
    FDA Recall Terminated

    syngo.plaza, Model number 10592457. Intended use: radiological image processing system.

    Recall: Z-2275-2012 · Initiated July 18, 2012

    Recall

    Recall Number
    Z-2275-2012
    Event Number
    62679
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 18, 2012
    Posted
    August 27, 2012
    Terminated
    January 24, 2014
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    Description

    syngo.plaza, Model number 10592457. Intended use: radiological image processing system.

    Reason

    There is a potential malfunction in which a miscalculation occurs for images with pixel depth values greater that 12 bit in certain functions.

    Action

    The firm initiated their recall/correction of this device on July 18, 2012 by sending a "Customer Safety Advisory Notice" letter, dated July 12, 2012, to their consignees. The letter identified the affected product along with the malfunction. It also discussed the steps the user can take to avoid the issue. Users were asked to not use the mentioned functions for images from those modalities until the issue was resolved and the system was updated with the software version containing the solution. Users were to contact their local Siemens Service in order to plan for the updated software version that will resolve the issue. Additionally, users should place the safety advisory notice in the system's instructions for use, and personnel should be instructed accordingly and maintain awareness. If the device was sold and is no longer in the users' possession, the notice should be forwarded to the new owner and the firm should be notified of the new owner.

    Distribution

    Nationwide Distribution -- CA, FL, GA, MA, MN, MO, NJ, NY, OH, WA, and WI.

    Quantity

    14