BEUDAMED
    FDA Recall Terminated

    C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    Recall: Z-2567-2014 · Initiated June 17, 2014

    Recall

    Recall Number
    Z-2567-2014
    Event Number
    68627
    Firm
    Varian Medical Systems, Inc.
    FEI Number
    2916710
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    June 17, 2014
    Posted
    September 13, 2014
    Terminated
    September 20, 2018
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    Reason

    Trend in reports of unexpected decrease in beam output in C-series High Energy Linear Accelerators for 6MV photon treatment mode.

    Action

    Urgent Medical Device correction letters were sent on June 16, 2017 to all affected users by certified mail.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Byelarus, Belgium, Bosniak, Brazil;, Bulgaria, Burma, Canada, Chile, China, Columbia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Germany, hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Luxembourg, Macau, Macedonia, Malaysia, Mauritania, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia,, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Venezuela.

    Quantity

    3416