BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-0447-2024 · Reported December 13, 2023

    Enforcement

    Recall Number
    Z-0447-2024
    Event ID
    93264
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Elekta, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 13, 2023
    Initiation Date
    October 25, 2023
    Classification Date
    December 1, 2023
    Address
    400 Perimeter Center Ter NE Ste 50, Atlanta, GA, 30346-1227, United States

    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.

    Code Info

    UDI/DI N/A, Serial Numbers: 152140, 152617, 152691, 152004, 152683, 152994, 153935, 152620, 152809, 152854, 152867, 152885, 152964, 152974, 153192, 153217, 153527, 152499, 153668, 152519, 153118, 153102, 153204, 153166, 152017, 152112, 152325, 152749, 152754, 152755, 152756, 152860, 153006, 151874, 152538, 152839, 152921, 153149, 153267, 152736, 151793, 151802, 151812, 151960, 152600, 152678, 152838

    Distribution

    worldwide

    Quantity

    47 units