BEUDAMED
    FDA Recall Open, Classified

    Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use

    Recall: Z-2106-2023 · Initiated May 25, 2023

    Recall

    Recall Number
    Z-2106-2023
    Event Number
    92515
    Firm
    Philips Respironics, Inc.
    FEI Number
    2518422
    Product Code
    CBK
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    May 25, 2023
    Posted
    July 7, 2023
    Address
    1001 Murry Ridge Ln, Murrysville, PA, 15668-8517

    Description

    Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use

    Reason

    There are errors present in the Korean Instructions For Use where the word "invasive," was incorrectly translated to "noninvasive".

    Action

    Customers were mailed a recall notification dated 05/23/2023 identifying the reason for recall as a mistranslation from "invasive" to "non-invasive" in the Korean IFUs. Customers are to refer to the correct instructions as listed in the recall notification when referring to the updated IFU pages, keep a copy of the recall notification with the IFU, communicate the recall notification to all who need to be aware in their organization, and complete and return the provided Field Safety Notice Response Form. The response form can be returned to the Philips representative indicated in your specific recall notification.

    Distribution

    Foreign Distribution: Korea.

    Quantity

    1,581 units