BEUDAMED
    FDA Recall Terminated

    Varian brand Clinac C-series Pendant Radiation delivery system. All model numbers included. Model numbers 2100, 2100C/D, 21 EX. 2300 C/D, 23 EX, 600C, 600 C/D, 2500 C, Trilogy, 6EX and Silhouette.

    Recall: Z-1206-06 · Initiated June 6, 2006

    Recall

    Recall Number
    Z-1206-06
    Event Number
    35728
    Firm
    Varian Medical Systems Inc
    FEI Number
    2916710
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 6, 2006
    Posted
    July 6, 2006
    Terminated
    December 3, 2007
    Address
    911 Hansen Way, Palo Alto, CA, 94304

    Description

    Varian brand Clinac C-series Pendant Radiation delivery system. All model numbers included. Model numbers 2100, 2100C/D, 21 EX. 2300 C/D, 23 EX, 600C, 600 C/D, 2500 C, Trilogy, 6EX and Silhouette.

    Reason

    Machine may produce unexpected motions from the couch, collimator, and gantry rotation at maximum speeds.

    Action

    The firm has initiated recall by sending its consignees a product notification letter 06/06/2006, and intends to dispatch service representatives to perform necessary modifications.

    Distribution

    Worldwide

    Quantity

    217 units