BEUDAMED
    FDA Recall Open, Classified

    ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    Recall: Z-0447-2024 · Initiated October 25, 2023

    Recall

    Recall Number
    Z-0447-2024
    Event Number
    93264
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    IYE
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    October 25, 2023
    Posted
    December 1, 2023
    Address
    400 Perimeter Center Ter NE, Ste 50, Atlanta, GA, 30346-1227

    Description

    ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    Reason

    Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.

    Action

    Elekta released Field Safety Notice to its consignees on the 10/25/2023 via email. The notice explained the issue, potential risk, and provides information for the safe use of the instrument until Elekta Field Service Representatives can perform the correction.

    Distribution

    worldwide

    Quantity

    47 units