BEUDAMED
    FDA Enforcement Class III Ongoing

    ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgical treatment options

    Recall: Z-2041-2020 · Reported May 27, 2020

    Enforcement

    Recall Number
    Z-2041-2020
    Event ID
    85475
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Immersivetouch Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 27, 2020
    Initiation Date
    April 3, 2020
    Classification Date
    May 18, 2020
    Address
    910 W Van Buren St Ste 715, N/A, Chicago, IL, 60607-3573, United States

    Description

    ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgical treatment options

    Reason

    Observed an internal repetitive software glitch in ImmersiveView.

    Code Info

    V 2.1

    Distribution

    The device was distributed in the state of Illinois only.

    Quantity

    2 units