BEUDAMED
    FDA Recall Open, Classified

    Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy

    Recall: Z-1665-2023 · Initiated May 5, 2023

    Recall

    Recall Number
    Z-1665-2023
    Event Number
    92270
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    IYE
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    May 5, 2023
    Posted
    May 30, 2023
    Address
    400 Perimeter Center Ter NE, Ste 50, Atlanta, GA, 30346-1227

    Description

    Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy

    Reason

    A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601

    Action

    Elekta notified customers, via email, on 05/05/2023. Customers were instructed that Elekta will contact each impacted customer to perform an onsite inspection of the power supply unit and replace as needed. Customers were asked to complete and return the Acknowledgement Form.

    Distribution

    Worldwide distribution. US distribution to AR, IN, LA, OK, TN, VA, WA. International distribution to Belgium, Canada, Chile, China, France, Germany, India, Iraq, Italy, Jordan, Libyan Arab Jamahiriya, Mauritius, Mexico, Morocco, Poland, Russian Federation, Spain.

    Quantity

    46 units