BEUDAMED
    FDA Recall Terminated

    Medical Linear Accelerator

    Recall: Z-2721-2016 · Initiated July 8, 2016

    Recall

    Recall Number
    Z-2721-2016
    Event Number
    75052
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 8, 2016
    Terminated
    November 24, 2017
    Address
    400 Perimeter Center Ter NE, Ste 50, Atlanta, GA, 30346-1227

    Description

    Medical Linear Accelerator

    Reason

    There have been instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue failure of some of the securing bolts.

    Action

    Important Field Safety Notice 200-01-103-081 was released July 8, 2016 for distribution to all customers with Digital Accelerators without XVI. It informs users of the specific product and version numbers affected by the issue. The modification involves an inspection and correction procedure. Should the inspection pass, the corrected in not required. All gantry base wheel bolts should be checked for presence and torque and should be replaced if found to be showing signs of fatigue. Elekta service is actively reaching out to affected customers in order to organize a time to implement the inspection and correction. The notice included an acknowledgment form to be returned.

    Distribution

    AL, AZ, CA, FL, GA, KY, MI, MN, MO, NE, NJ, NY, NC, OH, OK, PA, SC, TX, WA, WV, Argentina, Austria, Australia, Bosnia and Herzegovinia, Bangladesh, Belgium, Bulgaria, Brazil, China, Columbia, Cuba, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, Indonesia, Ireland, Israel, India, Iran, Italy, Japan, Jordan, Lebanon, Libya, Morocco, Mexico, Nigeria, Netherlands, Norway, Pakistan, Panama, Peru, Philippines, Portugal, Serbia, Slovenia, South Africa, South Korea, Spain, Sudan, Sweden, Syria, Taiwan, Thailand, Turkey, United Kingdom, Venezuela, Vietnam, Yemen

    Quantity

    553