BEUDAMED
    FDA Recall Terminated

    Varian Medical Systems Clinac Medical Linear Accelerator. Clinac 600 C &C/D, Clinac 2100 C, C/D & EX and Clinac 2300 C &C/D

    Recall: Z-1074-2007 · Initiated May 2, 2007

    Recall

    Recall Number
    Z-1074-2007
    Event Number
    38048
    Firm
    Varian Medical Systems Inc
    FEI Number
    2916710
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 2, 2007
    Posted
    July 12, 2007
    Terminated
    November 27, 2010
    Address
    911 Hansen Way, Palo Alto, CA, 94304

    Description

    Varian Medical Systems Clinac Medical Linear Accelerator. Clinac 600 C &C/D, Clinac 2100 C, C/D & EX and Clinac 2300 C &C/D

    Reason

    The wedge tray may slip out of the Clinac interface mount during gantry rotation.

    Action

    The firm sent out a Product Notification Letter on 5/2/07 to customers who have ordered this guide block through a Varian Service Center. A Varian Field Engineer will visually inspect guide blocks at-site that have been installed from Service stock for all affected customers, and replace if necessary.

    Distribution

    Product was distributed and manufactured between 1999 and 2006. Distributed worldwide, including USA, Ecuador, Columbia, Taiwan, Austrailia, Austria, Brazil, Canada, Chile, China, Finland, France, Germany, India, Italy, Japan, New Zealand, Poland, Portugal, Serbia and Montenegro, Singapore, Spain, Switzerland, UAE, and UK.

    Quantity

    209 units