BEUDAMED
    FDA Recall Terminated

    VariSeed 7.1, software application, part number H62, manufactured by Varian Medical Systems. VariSeed 7.1 is a computer based software application for planning and evaluating prostate brachytherapy procedures.

    Recall: Z-1385-2012 · Initiated January 25, 2012

    Recall

    Recall Number
    Z-1385-2012
    Event Number
    61364
    Firm
    Varian Medical Systems, Inc.
    FEI Number
    3000206172
    Product Code
    KXK
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    January 25, 2012
    Posted
    April 10, 2012
    Terminated
    November 7, 2012
    Address
    700 Harris St, Ste 109, Charlottesville, VA, 22903-4584

    Description

    VariSeed 7.1, software application, part number H62, manufactured by Varian Medical Systems. VariSeed 7.1 is a computer based software application for planning and evaluating prostate brachytherapy procedures.

    Reason

    Brachytherapy device requires the user to enter radioactive source activity, but software may specify unintended units for activity and lead to overdose in patient treatment.

    Action

    Varian Medical Systems notified direct account healthcare practitioners/ medical physicists with "Urgent Medical Device Correction/Urgent Field Safety Notice" letters by mail on 01/19/2012. Varian's advisory described how to mitigate user error and the firm's intentions to revise Instructions for Use. Technical Support phone numbers were provided for US and international customers.

    Distribution

    Worldwide Distribution

    Quantity

    1377 units