BEUDAMED
    FDA Enforcement Class III Ongoing

    Navik 3D v2, REF NAVIK3D, 3D Mapping System

    Recall: Z-0556-2024 · Reported December 20, 2023

    Enforcement

    Recall Number
    Z-0556-2024
    Event ID
    93419
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    APN Health LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 20, 2023
    Initiation Date
    November 7, 2023
    Classification Date
    December 14, 2023
    Address
    20935 Swenson Dr Ste 160, N/A, Waukesha, WI, 53186-2057, United States

    Description

    Navik 3D v2, REF NAVIK3D, 3D Mapping System

    Reason

    IFU update

    Code Info

    UDI (01)00869781000308(11)180309(21)2UA7520XNT

    Distribution

    US Nationwide distribution in the state of WI.

    Quantity

    1 unit