BEUDAMED
    FDA Enforcement Class II Ongoing

    NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2

    Recall: Z-1223-2022 · Reported June 8, 2022

    Enforcement

    Recall Number
    Z-1223-2022
    Event ID
    90163
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Xomed, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 8, 2022
    Initiation Date
    May 3, 2022
    Classification Date
    June 2, 2022
    Address
    6743 Southpoint Dr N, N/A, Jacksonville, FL, 32216-6218, United States

    Description

    NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2

    Reason

    Software anomaly was identified.

    Code Info

    Model Number: NIM4CM01; UDI/DI: 00763000395896, lot numbers: C2026207, C2026233, C2026320, C2026335, C2026354, C2026376, C2110046, C2110089, C2110131, C2110196, C2110198, C2110208, C2110217, C2110223 and 00763000002978, lot numbers: C1915048, C1915078, C1915099, C1915188, C2026207, C2026233, C2026320, C2026335, C2026354, C2026376, C2110046, C2110089, C2110131, C2110196, C2110198, C2110208, C2110217, C2110223.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of TX, CO, NJ and the country of France.

    Quantity

    18 units