BEUDAMED
    FDA Enforcement Class II Terminated

    Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100

    Recall: Z-1264-2021 · Reported March 24, 2021

    Enforcement

    Recall Number
    Z-1264-2021
    Event ID
    87391
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Imactis
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    March 24, 2021
    Initiation Date
    February 11, 2021
    Classification Date
    March 16, 2021
    Termination Date
    October 5, 2023
    Address
    20 Rue Du Tour De L Eau, N/A, St Martin D Heres, N/A, N/A, France

    Description

    Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100

    Reason

    Defect in the mechanical assembly of the needle holder contained in the navigation kit. One of the 2 jaws of the needle holder does not provide gripping functionality; if the defect is not detected before use, it can cause poor needle guidance and a lack of precision during navigation causing an inaccurate needle position which could cause damage to organs or vasculature adjacent to the trajectory

    Code Info

    Lots #: 20060001, 20060005 UDI-DI: B681I101002

    Distribution

    NJ, NY, WI

    Quantity

    105 kits