BEUDAMED
    FDA Recall Terminated

    GammaMed Flexible Applicator probe; 3.2mm diameter, braced PVDF. Varian Medical Systems, Palo Alto, CA. Mfg by Varian Medical Systems, Haan GmbH. Flexible Applicator Robes are designed for brachytherapy intracavitary treatments in areas such as vagina, vagina stump or rectum.

    Recall: Z-3013-2011 · Initiated July 13, 2011

    Recall

    Recall Number
    Z-3013-2011
    Event Number
    59388
    Firm
    Varian Medical Systems, Inc. Oncology Systems
    FEI Number
    2916710
    Product Code
    JAQ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 13, 2011
    Posted
    August 12, 2011
    Terminated
    June 20, 2012
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    GammaMed Flexible Applicator probe; 3.2mm diameter, braced PVDF. Varian Medical Systems, Palo Alto, CA. Mfg by Varian Medical Systems, Haan GmbH. Flexible Applicator Robes are designed for brachytherapy intracavitary treatments in areas such as vagina, vagina stump or rectum.

    Reason

    Certain GammaMed Flexible applicator probes may not have been heat annealed during manufacturing to prevent shrinkage after autoclave.

    Action

    Varian Medical Systems, Inc. sent out Customer Technical bulletins in August 2008 and Urgent Medical Device Correction/Urgent Field Safety Notices on July 13, 2011 to all affected customers. The letter included description of device and problem. The current notice supplements and modifies previous instructions and ask that they stop using any flexible applicator probes in inventory. They are to be returned to Varian Brachy Therapy for replacement. Letter go on to list possible scenarios if the length deviation is not detected and advised all personnel working in the radiotherapy department should be notified of the recall. For additional information contact (800) 360-7909.

    Distribution

    Worldwide Distribution: Nationwide (USA) and including the countries of France, Germany, India, Trinidad and Tobago, United Kingdom, Canada, Nepal, Ukraine, Czech Republic, Bangladesh, Thailand, Turkey, Brazil, Estonia, Switzerland, Russia, Greece, Philippines, Spain, Belgium, Kuwait, Romania, Morocco, Mexico, Columbia, Austria, Poland, Kazahstan, Vietnam, Cyprus, New Zealand, Dominican Republic, Norway, Uzebestan, Hungary, Lebanon, South Africa, South Korea, Slovenia, Venezuela, Serbia, Tunisia, Pakistan, Macedonia, Ireland, Azerbajian, Ukraine, Morroco, Italy, Singapore, Nambia, Turkey, Sudan, and Taiwan.

    Quantity

    1343