BEUDAMED
    FDA Enforcement Class I Ongoing

    Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B, EU2100X15B, LA2100X15B, EE2100X15B, FX2100X15B, ES2100X15B, ND2100X15B, FR2100X14B, IT2100X21B, JP2100X16B, IN2100X19, EU2100X19. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.

    Recall: Z-0290-2025 · Reported November 20, 2024

    Enforcement

    Recall Number
    Z-0290-2025
    Event ID
    95486
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips Respironics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 20, 2024
    Initiation Date
    October 7, 2024
    Classification Date
    November 13, 2024
    Address
    1001 Murry Ridge Ln, N/A, Murrysville, PA, 15668-8517, United States

    Description

    Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B, EU2100X15B, LA2100X15B, EE2100X15B, FX2100X15B, ES2100X15B, ND2100X15B, FR2100X14B, IT2100X21B, JP2100X16B, IN2100X19, EU2100X19. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.

    Reason

    Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.

    Code Info

    Model Number (UDI-DI Number): DE2100X13B (606959054103); DS2100X11B (606959051997); EE2100X15B (606959055698); ES2100X15B (606959054097); EU2100X15B (606959055674); EU2100X19 (606959055681); FP2100X10 (606959062085); FR2100X14B (606959055643); FX2100X15B (606959061019); IA2100X15B (606959055636); IN2100X15B (606959054059); IN2100X19 (606959055575); IT2100X21B (606959055438); JP2100X16B (606959055582); LA2100X15B (606959055599); ND2100X15B (606959055650). All Serial Numbers.

    Distribution

    Worldwide distribution - US Nationwide and the countries of AE, AF, AR, AT, AU, BD, BE, BG, BH, BO, BR, BS, CA, CH, CL, CN, CO, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GE, GF, GI, GR, GT, HK, HR, HU, ID, IE, IL, IN, IT, JE, JO, JP, KE, KR, KW, LB, LT, LY, MA, ME, MK, MM, MQ, MT, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PF, PH, PK, PL, PT, PY, QA, RE, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, TZ, UA, UY, VN, YT, ZA, ZW.

    Quantity

    24,249 units