BEUDAMED
    FDA Enforcement Class II Ongoing

    Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B, IN2100X19, IT2100X21B, JP2100X16B, LA2100X15B, ND2100X15B, RDE2100X13B, SP2100X26B

    Recall: Z-2288-2021 · Reported August 25, 2021

    Enforcement

    Recall Number
    Z-2288-2021
    Event ID
    88333
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips Respironics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 25, 2021
    Initiation Date
    July 26, 2021
    Classification Date
    August 13, 2021
    Address
    1001 Murry Ridge Ln, N/A, Murrysville, PA, 15668-8517, United States

    Description

    Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B, IN2100X19, IT2100X21B, JP2100X16B, LA2100X15B, ND2100X15B, RDE2100X13B, SP2100X26B

    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).

    Code Info

    Software version numbers 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

    Distribution

    Worldwide distribution - US nationwide distribution.

    Quantity

    101 (FEMA Stockpile Only); 21077 (OUS)