BEUDAMED
    FDA Enforcement Class II Terminated

    Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument

    Recall: Z-1826-2020 · Reported May 6, 2020

    Enforcement

    Recall Number
    Z-1826-2020
    Event ID
    85352
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Elekta Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 6, 2020
    Initiation Date
    March 30, 2020
    Classification Date
    April 29, 2020
    Termination Date
    April 10, 2024
    Address
    1450 Beale St Ste 205, N/A, Saint Charles, MO, 63303, United States

    Description

    Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument

    Reason

    A faulty locking piece of the Instrument Carrier that does not fulfil the requirement of locking force to the Arc has been found during an internal check of a Leksell Vantage Stereotactic Arc System.

    Code Info

    Serial Numbers:SH00106, SH00120, SH00149, SH00160, SH00165, SH00110, SH00143, SH00150, SH00161, SH00166, SH00111, SH00144, SH00157, SH00162, SH00167, SH00112, SH00147, SH00158, SH00163, SH00168, SH00114, SH00148, SH00159, SH00164 and SH00178. UDI 7340048304887.

    Distribution

    US nationwide distributions in the states of MA, NH, NC, UT, OH, FL, MN, NY, LA and MT.

    Quantity

    25 units.