BEUDAMED
    FDA Enforcement Class II Terminated

    Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887

    Recall: Z-2442-2020 · Reported July 8, 2020

    Enforcement

    Recall Number
    Z-2442-2020
    Event ID
    85836
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Elekta Instrument AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 8, 2020
    Initiation Date
    June 10, 2020
    Classification Date
    June 26, 2020
    Termination Date
    August 27, 2024
    Address
    Kungstensgatan 18, N/A, Stockholm, N/A, N/A, Sweden

    Description

    Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887

    Reason

    The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly.

    Code Info

    Serial numbers: SH00026, SH00049, SH00061, SH00082, SH00092, SH00111, SH00028, SH00050, SH00072, SH00084, SH00094, SH00118, SH00029, SH00052, SH00073, SH00085, SH00095, SH00121, SH00030, SH00054, SH00074, SH00086, SH00097, SH00123, SH00032, SH00055, SH00077, SH00087, SH00099, SH00127, SH00033, SH00057, SH00078, SH00088, SH00100, SH00162, SH00041, SH00058, SH00079, SH00089, SH00102, SH00044, SH00059, SH00080, SH00090, SH00105, SH00045, SH00060, SH00081, SH00091, SH00108

    Distribution

    MA, IL, NH, NC, UT, OH, FL, MN, TX, NY, LA, AZ, MT, WV, Austria, Croatia, Estonia, Finland, France, Germany, Hong Kong, India, Italy, Japan, Kuwait, Lithuania, Netherlands, Norway, Portugal, South Africa, Spain, Sweden, Switzerland, United Kingdom

    Quantity

    51 devices