BEUDAMED
    FDA Recall Terminated

    Nucletron Adapter and Transfer Guide Tube Set, part number AL 13005001, set of 3 adapters, components used with the VariSource" IX HDR Afterloader. Product Usage: The adapter is part of the VariSource Afterloader System, a computer controlled remote HDR Afterloader used to place a high activity radioactive source within a needle(s) or applicator(s) which have previously been placed for a specific clinical purpose in a patient.

    Recall: Z-1200-2012 · Initiated January 5, 2012

    Recall

    Recall Number
    Z-1200-2012
    Event Number
    61179
    Firm
    Varian Medical Systems, Inc.
    FEI Number
    3000206172
    Product Code
    JAQ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 5, 2012
    Posted
    March 12, 2012
    Terminated
    November 21, 2012
    Address
    700 Harris St, Ste 109, Charlottesville, VA, 22903-4584

    Description

    Nucletron Adapter and Transfer Guide Tube Set, part number AL 13005001, set of 3 adapters, components used with the VariSource" IX HDR Afterloader. Product Usage: The adapter is part of the VariSource Afterloader System, a computer controlled remote HDR Afterloader used to place a high activity radioactive source within a needle(s) or applicator(s) which have previously been placed for a specific clinical purpose in a patient.

    Reason

    Components of medical device used in brachytherapy may be defective and cause a shifted dose distribution to patients.

    Action

    Varian Medical Systems sent an Urgent Medical Device Correction - Urgent Field Safety Notice letter dated January 5, 2012 to all affected consignees. The letter identified the affected products, description of problem and recommended user actions to be taken. Consignees were requested to cease use of the affected products and contact Varian BrachyTherapy Helpdesk immediately to arrange return of their affected parts. Consignees were requested to return the enclosed proof of notification form. Consignees were instructed to advise the appropriate personnel working in their radiotherapy department of the content of this letter. For future reference, this document will be posted to the Varian Customer Support website: http://www.MyVarian.com. For further clarification contact your local Varian District or Regional Manager.

    Distribution

    Worldwide Distribution - USA (nationwide) Including the states of CA, FL, IN, KY, MI, MN, MO, OH, TX, VA and the countries of Canada, Japan and Sweden.

    Quantity

    122 total units