BEUDAMED
    FDA Enforcement Class II Terminated

    Segmented Cervix Applicator Set, part number GM11004310, a component used with the tube for segments and cervical sleeves The guide tube for segments and cervical sleeves in the Segmented Cervix Applicator Set was developed to treat cancer of the cervix, vagina, endometrium, vaginal stump and uterus. It is used for Brachytherapy.

    Recall: Z-0607-2013 · Reported December 26, 2012

    Enforcement

    Recall Number
    Z-0607-2013
    Event ID
    63667
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Varian Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 26, 2012
    Initiation Date
    September 28, 2012
    Classification Date
    December 20, 2012
    Termination Date
    April 2, 2013
    Address
    700 Harris St Ste 109, Charlottesville, VA, 22903-4584, United States

    Description

    Segmented Cervix Applicator Set, part number GM11004310, a component used with the tube for segments and cervical sleeves The guide tube for segments and cervical sleeves in the Segmented Cervix Applicator Set was developed to treat cancer of the cervix, vagina, endometrium, vaginal stump and uterus. It is used for Brachytherapy.

    Reason

    The guide tube which is part of the Segmented Cervix Applicator Set is difficult to disconnect from cervical sleeve.

    Code Info

    Lot L33, Serial numbers H64Y009-GM, H64A056, H640576, H600272, H640784, H640774, H640764, H600603, H640547,

    Distribution

    Worldwide Distribution - U.S. state of Georgia and the countries of Canada, Germany, India, Poland, and Thailand.

    Quantity

    15 units