BEUDAMED
    FDA Enforcement Class II Ongoing

    NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2

    Recall: Z-1224-2022 · Reported June 8, 2022

    Enforcement

    Recall Number
    Z-1224-2022
    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 Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2

    Reason

    Software anomaly was identified.

    Code Info

    Model Number: NIM4CPB1; UDI/DI: 00763000002985, lot numbers: P1910256, P1910260, P1910402, P1910404, P2008073, P2008130, P2008131 and 00763000395902, lot numbers: P2026275, P2026290, P2026329, P2026330, P2026357, P2026388, P2026389, P2026680, P2026681, P2026718, P2026719, P2026793, P2026956, P2026957, P2026958, P2026959, P2026981, P2026994, P2026995, P2127005, P2127006, P2127013

    Distribution

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

    Quantity

    29 units