BEUDAMED
    FDA Recall Terminated

    Clinac Linear Accelerator; Model numbers H14, H27 and H29. Product Usage: Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

    Recall: Z-2764-2011 · Initiated May 18, 2011

    Recall

    Recall Number
    Z-2764-2011
    Event Number
    58976
    Firm
    Varian Medical Systems, Inc. Oncology Systems
    FEI Number
    2916710
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 18, 2011
    Posted
    July 8, 2011
    Terminated
    March 13, 2012
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    Clinac Linear Accelerator; Model numbers H14, H27 and H29. Product Usage: Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

    Reason

    The Coolant System input water supply manifold may leak in some Clinac Linear Accelerators, posing a risk of electrical shock to any person working within the protective housing.

    Action

    Varian Medical Systems, Inc. Oncology Systems sent an "URGENT MEDICAL DEVICE CORRECTION" letters on May 18, 2011, via certified mail, return receipt requested. The letter identified the product, problem and recommended actions to be taken. The letter states that customers will be contacted by Varian Service to arrange for replacement of the recalled product. For additional information contact Varian Medical Systems, Inc at 888- 827-4265.

    Distribution

    Worldwide Distribution -- USA (nationwide) and countries of: Australia, Columbia, Denmark, France, Ireland, Italy, Japan, Morocco, Poland, Portugal, Saudi Arabia, South Korea, Spain, and United Kingdom.

    Quantity

    93