BEUDAMED
    FDA Recall Terminated

    Theratron 1000 Cobalt Radiotherapy

    Recall: Z-1180-06 · Initiated July 8, 2004

    Recall

    Recall Number
    Z-1180-06
    Event Number
    35617
    Firm
    MDS Canada Inc. DBA MDS Nordion
    FEI Number
    3001092088
    Product Code
    IWB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 8, 2004
    Posted
    June 27, 2006
    Terminated
    June 27, 2006
    Address
    447 March Road, Kanata Canada

    Description

    Theratron 1000 Cobalt Radiotherapy

    Reason

    The source locking device may not fit properly through the smaller opening in the new field light shield which could prevent the source from being returned manually under emergency conditions.

    Action

    A User Bulletin (CUB-2004-01dated 7/5/04) was issued to affected users on 8/24/04 and 8/31/04. The bulletin provided 2 options for corrective action.

    Distribution

    The products were shipped to medical facilities in FL and KS. The product was also shipped to Kuwait, Spain, Honduras, Romania, France, Grrece, Bangladesh, Germany, Nepal, Canada, England, Thailand, Phillippines, Mexico, Columbia, India, Switzerland, Syria, Trinidad & Tobago, Ireland, Turkey, Algeria, Portugal, Poland, Iran, China, Cuba, Belgium, Hungary, Egypt, Italy, Vietnam, Sri Lanka, and Costa Rica.

    Quantity

    16 units