BEUDAMED
    FDA Recall 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 · Initiated September 28, 2012

    Recall

    Recall Number
    Z-0607-2013
    Event Number
    63667
    Firm
    Varian Medical Systems, Inc.
    FEI Number
    3000206172
    Product Code
    JAQ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 28, 2012
    Posted
    December 20, 2012
    Terminated
    April 2, 2013
    Address
    700 Harris St, Ste 109, Charlottesville, VA, 22903-4584

    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.

    Action

    The firm, Varian Medical Systems, sent an "URGENT MEDICAL DEVICE CORRECTION - URGENT FIELD SAFETY NOTICE" letter dated September 28, 2012 to all affected consignees/Customers. The letter identified the affected product, description of problem and recommended user actions to be taken. The consignees/customers were instructed to immediately remove all affected guiding tubes from clinical use, and sequester the components for pending return to Varian Brachy Therapy. Consignees/Customers were requested to complete the attached proof of notification form and return it to Varian Medical Systems. For questions contact-AT&T international direct dialing network (http://www.business.att.com/bt/dial_guide.isp. Then after hearing the AT&T signature noise, and. "Please enter the number you are calling", dial 800-360-7909; UK:+44 1293-601-327 or US:+1-434-979-1540. To submit a support request or general inquiry, compose an email with a blank subject line to: [email protected].

    Distribution

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

    Quantity

    15 units