BEUDAMED
    FDA Recall Terminated

    Artiste MV system, Part number 8139789, medical linear accelerator equipped with COHERENCE therapist RTT4.1. Medical Linear accelerator for radiation therapy. The device utilizes a console system for selecting various treatment sequences and manages commands for all motorized movement.

    Recall: Z-0116-2009 · Initiated July 4, 2008

    Recall

    Recall Number
    Z-0116-2009
    Event Number
    49024
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2937457
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software change control
    Initiated
    July 4, 2008
    Posted
    October 20, 2008
    Terminated
    December 22, 2010
    Address
    4040 Nelson Ave, Concord, CA, 94520-1200

    Description

    Artiste MV system, Part number 8139789, medical linear accelerator equipped with COHERENCE therapist RTT4.1. Medical Linear accelerator for radiation therapy. The device utilizes a console system for selecting various treatment sequences and manages commands for all motorized movement.

    Reason

    Three issues: unexpected rotation of gantry, unexpected movement of table between beams during patient setup, and single exposure images will be overwritten by double exposure images.

    Action

    A letter marked "Urgent" dated July 4, 2008 was sent to customers. The letter provided a detailed description of the issues, the conditions under which these issues may occur, as well as recommendations to avoid these issues. Customer notification TH022/08/S was released on July 11, 2008. A software fix is currently being validated. All consignees notified by certified mail. Contact Siemens Medical Solutions USA, Inc. at 1-925-246-8407 for assistance.

    Distribution

    Nationwide in LA, WI, DE, PA and OH, and internationally in Netherlands, Germany, Poland, Norway, Australia, Hungary, Belgium and France

    Quantity

    16