BEUDAMED
    FDA Recall Terminated

    Varian Medical Systems On-Board Imager, Versions 1.0.15 and 1.2.05 Imaging Accessory to Medical Linear Accelerator. The On-Board Imager Device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial landmarks.

    Recall: Z-1442-2008 · Initiated January 3, 2008

    Recall

    Recall Number
    Z-1442-2008
    Event Number
    46920
    Firm
    Varian Medical Systems Oncology Systems
    FEI Number
    2916710
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 3, 2008
    Posted
    August 15, 2008
    Terminated
    November 27, 2010
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    Varian Medical Systems On-Board Imager, Versions 1.0.15 and 1.2.05 Imaging Accessory to Medical Linear Accelerator. The On-Board Imager Device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial landmarks.

    Reason

    If used with a third party radiation therapy treatment planning software system, mistreatment may occur because of a misalignment.

    Action

    The firm has upgraded all user sites through normal course of service and installation activities. Notification letters were distributed starting January 03, 2008.

    Distribution

    Worldwide Distribution -- USA including states of GA, MI, NY, MN, TX, TN, CA, MD, KS, AL, KY, CT, WI, LA, NC, NJ, PA, IL, RI, FL, NE, AK, VA, WV, NV, MO, TN, OR, IN, MA, CT, AL, AZ, NH, ID, OH, SC, CO, CT, ND, WA, and UT, and countries of Sweden, Switzerland, Germany, Denmark, Japan, UK, France, Italy, Norway, Taiwan, New Zealand, Canada, Poland, Australia, Colombia, China, Spain, Belgium, Russian Federation, India, Iceland.

    Quantity

    291 units