BEUDAMED
    FDA Enforcement Class II Ongoing

    Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)

    Recall: Z-2972-2020 · Reported September 23, 2020

    Enforcement

    Recall Number
    Z-2972-2020
    Event ID
    85258
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Imactis
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 23, 2020
    Initiation Date
    August 24, 2020
    Classification Date
    September 15, 2020
    Address
    20 Rue Du Tour De L Eau, N/A, St Martin D Heres, N/A, N/A, France

    Description

    Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)

    Reason

    The firm has received reports concerning the patient fiducial disk separating from the body and users attempting to re-assemble the device. The use of a re-assembled patient fiducial could lead to inability to navigate or inaccuracies such as improper needle trajectory.

    Code Info

    All Serial Numbers

    Distribution

    US Nationwide distribution including in the states of FL & WI.

    Quantity

    6 Navigation Systems