BEUDAMED
    FDA Recall Terminated

    Leonardo Workstation Picture Archiving and Communication System, Model Number: 7129534, Software Version: VB30B, Siemens Medical Solutions, Inc., Malvern, PA 19355

    Recall: Z-1038-2008 · Initiated December 21, 2007

    Recall

    Recall Number
    Z-1038-2008
    Event Number
    46360
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 21, 2007
    Posted
    April 29, 2008
    Terminated
    September 30, 2008
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355-1406

    Description

    Leonardo Workstation Picture Archiving and Communication System, Model Number: 7129534, Software Version: VB30B, Siemens Medical Solutions, Inc., Malvern, PA 19355

    Reason

    Incorrect display: The orientation labels will be incorrectly displayed on the reconstructed InSpace 3-D image if the orientation was not originally HFS on the acquisition system.

    Action

    Siemens Medical Solutions issued a Customer Safety Advisory Notice dated 12/21/07 to its customers to inform them of the problem and instructions to avoid the problem until the firm's representative is available to upgrade the software.

    Distribution

    Nationwide Distribution.

    Quantity

    47 Units