BEUDAMED
    FDA Recall Terminated

    EPROM and Control Software (embedded), version 5.08, for the GammaMed 12i/t Afterloader, manufactured by Varian Medical Systems, Inc, Palo Alto, CA 94304.

    Recall: Z-0582-04 · Initiated February 6, 2004

    Recall

    Recall Number
    Z-0582-04
    Event Number
    28300
    Firm
    Varian Medical Systems
    FEI Number
    3000206172
    Product Code
    JAQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 6, 2004
    Posted
    July 20, 2004
    Terminated
    September 21, 2004
    Address
    700 Harris St, Suite 109, Charlottesville, VA, 22903-4584

    Description

    EPROM and Control Software (embedded), version 5.08, for the GammaMed 12i/t Afterloader, manufactured by Varian Medical Systems, Inc, Palo Alto, CA 94304.

    Reason

    Radiation treatment software could potentially cause a healthcare practitioner to apply incorrect treatment regimen to patients undergoing brachytherapy.

    Action

    The recalling firm notified end users by letters flagged 'Urgent Medical Device Correction' on 2/2/04. The notification reminds users to verify the decay factor before patient treatment. The letter also advises that instrument software be be updated commencing March 2004.

    Distribution

    Product was distributed to end users in the United States and internationally.

    Quantity

    203