BEUDAMED
    FDA Recall Terminated

    Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is part of the class of medical devices that are used in radiotherapy for the treatments of head tumors.

    Recall: Z-0138-2014 · Initiated July 23, 2013

    Recall

    Recall Number
    Z-0138-2014
    Event Number
    65782
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    HAW
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    July 23, 2013
    Posted
    November 4, 2013
    Terminated
    November 18, 2014
    Address
    400 Perimeter Center Ter Ne, Ste 50, Atlanta, GA, 30346-1227

    Description

    Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is part of the class of medical devices that are used in radiotherapy for the treatments of head tumors.

    Reason

    Potential for clinical errors.

    Action

    Elekta sent an Important Field Safety Notice dated 7/2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised of the issue and recommendation to resolve either by upgrading their system or to discontinue a clinical use of the device. For further questions please call ( 770 ) 300-9725.

    Distribution

    Nationwide distribution: USA including the states of AZ, CA, FL, GA, MO, NJ, NM, NC, OR, TN and WV.

    Quantity

    89