BEUDAMED
    FDA Recall Terminated

    BrachyVision, versions 8.2, 8.5, 8.6 and 8.9. Varian Medical Systems. 3100 Hansen Way, Palo Alto, California 94304-1038. Used to plan radiotherapy treatments for patients with malignant or benign diseases. In addition, the module is specifically indicated for planning proton treatment of neoplasms of the eye.

    Recall: Z-3103-2011 · Initiated August 11, 2010

    Recall

    Recall Number
    Z-3103-2011
    Event Number
    59217
    Firm
    Varian Medical Systems, Inc.
    FEI Number
    3000206172
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 11, 2010
    Posted
    August 31, 2011
    Terminated
    November 25, 2011
    Address
    700 Harris St, Ste 109, Charlottesville, VA, 22903-4584

    Description

    BrachyVision, versions 8.2, 8.5, 8.6 and 8.9. Varian Medical Systems. 3100 Hansen Way, Palo Alto, California 94304-1038. Used to plan radiotherapy treatments for patients with malignant or benign diseases. In addition, the module is specifically indicated for planning proton treatment of neoplasms of the eye.

    Reason

    Medical device for brachytherapy treatment may cause users to enter incorrect syntax and lead to potential misinterpretation of patient treatment plan.

    Action

    Varian Medical Systems, Inc. sent a "Medical Device Recall" letter dated August 05, 2010 to all affected customers. The letter included description of product affected and problem. Customers were advised to review template files to ensure that there are no characters immediately after the string in the customized dose quality parameters. Device users were requested to return a response form. For information on this recall contact Varian Technical Support at (800) 360-7909.

    Distribution

    Worldwide and Nationwide Distribution.

    Quantity

    1252 units