BEUDAMED
    FDA Recall Terminated

    ExacTrac Robotics, sold alone as Robotic Tilt Module catalog 49720 and in a bundle as catalog 49700, for installation on the Varian Exact Couch, a component of the Novalis Shaped Beam Surgery System; a table tilt device - powered radiation therapy patient support assembly; BrainLab AG, Ammerthalstrasse 8, 85551 Heimstetten, Germany

    Recall: Z-1255-06 · Initiated June 2, 2006

    Recall

    Recall Number
    Z-1255-06
    Event Number
    35742
    Firm
    Brainlab AG Ammerthalstrasse 8 Kirchheim B. Muenchen Germany
    FEI Number
    3002619595
    Product Code
    JAI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 2, 2006
    Posted
    July 27, 2006
    Terminated
    February 24, 2008

    Description

    ExacTrac Robotics, sold alone as Robotic Tilt Module catalog 49720 and in a bundle as catalog 49700, for installation on the Varian Exact Couch, a component of the Novalis Shaped Beam Surgery System; a table tilt device - powered radiation therapy patient support assembly; BrainLab AG, Ammerthalstrasse 8, 85551 Heimstetten, Germany

    Reason

    During ExacTrac Robotics installation on the Varian Exact Couch, the couch height position indication is re-calibrated to read out the correct positions. This re-calibration could cause the eventual failure of the vertical lift mechanism of the couch, which might result in patient injury or death.

    Action

    BrainLab issued a Product Notification Letter to the hospitals on 6/2/06 to advise the users not to lower the couch below 50 cm, and sent a second letter to the users on 6/7/06, informing them that BrainLab would remove the ExacTrac Robotics from the Exact Couch and re-calibrate the couch to restore the software limit switch. The Robotics will be re-installed once a permanent solution is available.

    Distribution

    Nationwide, including the states of California, Colorado, Florida, Illinois, Maryland, Michigan, Missouri, New Hampshire, New York, North Carolina, Ohio, Pennsylvania, Tennessee and Texas

    Quantity

    19 devices