BEUDAMED
    FDA Enforcement Class I Ongoing

    Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.

    Recall: Z-1505-2024 · Reported April 24, 2024

    Enforcement

    Recall Number
    Z-1505-2024
    Event ID
    94263
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips Respironics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 24, 2024
    Initiation Date
    March 19, 2024
    Classification Date
    April 17, 2024
    Address
    1001 Murry Ridge Ln, Murrysville, PA, 15668-8517, United States

    Description

    Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.

    Reason

    Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

    Code Info

    Model No. DS2000X11B; UDI-DI: 606959052000; All units except those with software version 1.05.06.00.

    Distribution

    Domestic: Nationwide Distribution; Foreign: AE, AR, AT, AU, BD, BE, BG, 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, MA, ME, MK, MM, MQ, MT, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PF, PH, PK, PL, PR, PT, PY, QA, RE, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, US, UY, VN, YT, ZA, ZW.

    Quantity

    9,999 units