BEUDAMED
    FDA Recall Terminated

    Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    Recall: Z-1325-2013 · Initiated May 31, 2011

    Recall

    Recall Number
    Z-1325-2013
    Event Number
    64997
    Firm
    Varian Medical Systems, Inc. Oncology Systems
    FEI Number
    2916710
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    May 31, 2011
    Posted
    May 15, 2013
    Terminated
    May 15, 2013
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    Reason

    Under certain conditions, photon beams in High Energy Clinacs may experience a gradual change in beam symmetry, potentially reaching an asymmetry of up to about 7% before interlock occurs. At maximum asymmetry, this may result in no more than about 3.5% dose deviation from expected at any point in the beam, and may result in minor injury to the patient or slightly decreased local disease control.

    Action

    Varian sent a Customer Technical Bulletin to all affected customers. The bulletin identified the affected product, problem and actions to be taken. For questions, issues, or concerns contact Varian at 1-888-827-4265 or go to http://my.varian.com

    Distribution

    Worldwide distribution - USA (nationwide) including Puerto Rico, and countries of: Algeria, Angola, Australia, Austria, Bahrain, Bangladesh, Belarus, Belguim, Brazil, Bosnia and Hezregovina, Bulgaria, Canada, Chile, China, Columbia, Cyprus, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, Frances, French Polynesia, Georgia, Germany, Greece, Gaudaloupe, Gaum, Hong Kong, India, Indonesia, Ireland, Italy, Israel, Latvia, Lithuania, Luxemburg, Japan, Kazarhstan, Kuwait, Lebanon, Macau, Macedonia, Malaysia, Martinique, Mauritania, Mexico, Moldova, Monaco, Morroco, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Peru, Phillipines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudia Arabia, Serbia, Singapore, Slovakia, Spain, South Africa, South Korea, Sri Lanka, Syria, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezula, Vietnam, and Zimbabwe.

    Quantity

    3943 units