BEUDAMED
    FDA Enforcement Class II Terminated

    Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR) Product Usage: Usage: Used during pulsed dose rate brachytherapy to treat vaginal and rectal cancer.

    Recall: Z-1324-2013 · Reported May 22, 2013

    Enforcement

    Recall Number
    Z-1324-2013
    Event ID
    64986
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Varian Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 22, 2013
    Initiation Date
    April 11, 2013
    Classification Date
    May 14, 2013
    Termination Date
    January 13, 2014
    Address
    700 Harris St Ste 109, Charlottesville, VA, 22903-4584, United States

    Description

    Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR) Product Usage: Usage: Used during pulsed dose rate brachytherapy to treat vaginal and rectal cancer.

    Reason

    Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to areas outside the target.

    Code Info

    Serial numbers H640383, H640277, H640384, H640788, H640D126, H640385, H640372, H640303, H640387

    Distribution

    Worldwide distribution: USA (nationwide) and in the countries of: Belgium, France, Martinique, Slovenia, Sweden, and the United Kingdom.

    Quantity

    21 devices