BEUDAMED
    FDA Enforcement Class II Ongoing

    Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS

    Recall: Z-2008-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-2008-2023
    Event ID
    92394
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Covidien, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 5, 2023
    Initiation Date
    May 22, 2023
    Classification Date
    June 26, 2023
    Address
    161 Cheshire Ln N Ste 100, N/A, Minneapolis, MN, 55441-5433, United States

    Description

    Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS

    Reason

    Single ILLUMISITE Platform Console was converted from a 220-240VAC model to a 120VAC configuration using a non-supplied power cord and non-supplied fuses in the field by Medtronic Field Service Engineer.

    Code Info

    UDI-DI: 10884521782211; Serial Number: 518503

    Distribution

    International distribution in the country of Taiwan.

    Quantity

    1 unit