BEUDAMED
    FDA Enforcement Class II Terminated

    Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093.

    Recall: Z-0115-2022 · Reported October 20, 2021

    Enforcement

    Recall Number
    Z-0115-2022
    Event ID
    88771
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ELEKTA SOLUTIONS AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 20, 2021
    Initiation Date
    September 28, 2021
    Classification Date
    October 14, 2021
    Termination Date
    June 14, 2024
    Address
    Box 7593, KUNGSTENSGATAN 18, Stockholm, N/A, N/A, Sweden

    Description

    Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093.

    Reason

    There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter.

    Code Info

    Elekta Harmony Pro, Serial #441009, UDI (01) 05060191071604; Elekta Infinity, Serial #156645, UDI (01) 05060191071543; and Elekta Versa HD, Serial #156646, #156477, and #156648, UDI (01) 05060191071574

    Distribution

    Distribution was to ND and NC. There was no military/government distribution.

    Quantity

    2 in the U.S.