BEUDAMED
    FDA Recall Terminated

    syngo Imaging, picture archiving and communications system. Model number 7502029

    Recall: Z-0070-2007 · Initiated September 5, 2006

    Recall

    Recall Number
    Z-0070-2007
    Event Number
    36529
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 5, 2006
    Posted
    October 25, 2006
    Terminated
    September 17, 2008
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355-1406

    Description

    syngo Imaging, picture archiving and communications system. Model number 7502029

    Reason

    Potential issue with annotation function. Annotations, shown as overlays, may change font size when the image is saved. Text may appear shifted, or lines appear thicker, and their position may not be as intended.

    Action

    The recalling firm has issued a Customer Safety Advisory via certified mail to affected customers per Update Instructions HS096/06/S and HS097/06/S. The letter, dated September 5, 2006, informs customers of this issue and provides recommendations to avoid its occurrence.

    Distribution

    The product was shipped to medical facilities nationwide.

    Quantity

    1818 units total, for all three products