BEUDAMED
    FDA Recall Terminated

    GammaMed Flexible Applicator Probe, Part GM11002560 - 3.2 mm diameter braced PVDF. Varian Medical Systems, Palo Alto, CA, Mfg. by Varian Medical Systems, Haan GmbH. Designed for brachytherapy intracavity treatments in areas such as cancer of the vagina, vaginal stump or rectum.

    Recall: Z-0295-2012 · Initiated August 5, 2008

    Recall

    Recall Number
    Z-0295-2012
    Event Number
    59856
    Firm
    Varian Medical Systems, Inc.
    FEI Number
    3000206172
    Product Code
    JAQ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 5, 2008
    Posted
    November 30, 2011
    Terminated
    December 7, 2011
    Address
    700 Harris St, Ste 109, Charlottesville, VA, 22903-4584

    Description

    GammaMed Flexible Applicator Probe, Part GM11002560 - 3.2 mm diameter braced PVDF. Varian Medical Systems, Palo Alto, CA, Mfg. by Varian Medical Systems, Haan GmbH. Designed for brachytherapy intracavity treatments in areas such as cancer of the vagina, vaginal stump or rectum.

    Reason

    GammaMed Flexible Applicator Probes may not have been heat annealed during manufacturing to prevent shrinkage after autoclave.

    Action

    Varian Medical Systems, Inc. sent a Customer Technical Bulletin CTB-GM-603A on August 5, 2008 to all affected customers. The letter included description of device and problem. The bulletin also advised that if they find that the applicator and source guide tube combination is not within the indicated range on the length gauge, to call VBT technical support using the contact information on page 5 of the bulletin to obtain a replacement applicator probe. Customers are to complete and return the attached verification card. If support is needed the letter provides customer support contact information.

    Distribution

    Worldwide Distribution -- USA (nationwide): Arkansas,California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Maine, Maryland, Massachusetts, Minnesota, Montana, Michigan, Missouri, Nebraska, Mississippi, New Jersey, Nevada, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, and Wisconsin, and the countries of Austria, Azerbaijan, Brazil, British Columbia, Canada, Chile, Germany, Greece, India, India, Ireland, Israel, Mexico, Morocco, Pakistan, Poland, Republic of Macedonia, Russia, Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, United Kingdom, Ukraine, and Venezuela.

    Quantity

    653 parts