BEUDAMED
    FDA Recall Open, Classified

    Trilogy Evo Universal, Product number DS2000X11B

    Recall: Z-2290-2021 · Initiated July 26, 2021

    Recall

    Recall Number
    Z-2290-2021
    Event Number
    88333
    Firm
    Philips Respironics, Inc.
    FEI Number
    2518422
    Product Code
    CBK
    Status
    Open, Classified
    Root Cause
    Labeling design
    Initiated
    July 26, 2021
    Address
    1001 Murry Ridge Ln, Murrysville, PA, 15668-8517

    Description

    Trilogy Evo Universal, Product number DS2000X11B

    Reason

    Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Drift (Continuous Usage).

    Action

    On July 26, 2021, the firm issued Urgent Medical Device Correction letters to affected customers. Customers were advised of the two software issues that the firm had identified related to pressure increase. Customers received guidance on how to identify affected products: Devices with software versions devices with software versions 1.02.01.00, 1.03.05.00, 1.03.07.00, 1.04.02.00, 1.04.06, 1.05.01 and 1.06.02 are impacted. Customers were provided with actions to take until the upcoming software fix is implemented on your device. Philips will be releasing a software correction to resolve this issue, and will contact customers when the software correction is released. If you need any further information or support concerning this issue, please contact Philips Customer Care Solutions Center Trilogy Evo: +1-800-345-6443 Option 2, Option 1 (Available 24/7) Trilogy EV300: +1-800-722-9377 (Available 24/7)

    Distribution

    Worldwide distribution - US nationwide distribution.

    Quantity

    10,000 (FEMA Stockpile Only)