BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2008-2023 · Initiated May 22, 2023

    Recall

    Recall Number
    Z-2008-2023
    Event Number
    92394
    Firm
    Covidien, LLC
    FEI Number
    3004962788
    Product Code
    JAK
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    May 22, 2023
    Posted
    June 26, 2023
    Address
    161 Cheshire Ln N, Ste 100, Minneapolis, MN, 55441-5433

    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.

    Action

    Covidien notified the single consignee via letter on 05/18/2023. The consignee was instructed to quarantine and return affected product, forward the notification to those who need to be aware within the organization and to any location which the device has been transferred and complete and return the Customer Confirmation Form.

    Distribution

    International distribution in the country of Taiwan.

    Quantity

    1 unit