BEUDAMED
    FDA Enforcement Class I Terminated

    Garbin EVO Ventilator, Linde - Model Number: LD2110X23B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.

    Recall: Z-0946-2020 · Reported February 26, 2020

    Enforcement

    Recall Number
    Z-0946-2020
    Event ID
    84406
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Respironics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 26, 2020
    Initiation Date
    November 19, 2019
    Classification Date
    February 14, 2020
    Termination Date
    March 31, 2021
    Address
    1001 Murry Ridge Ln, Murrysville, PA, 15668-8517, United States

    Description

    Garbin EVO Ventilator, Linde - Model Number: LD2110X23B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.

    Reason

    Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected result failing requirements TSRS1298 and PRD439.

    Code Info

    Model/Material Number: LD2110X23B Serial Numbers: H239876824C6F, H239876835DE6, H23987688E335, H239876943081, H23987698FAED, H239877197F78, H23987731C080, H23987734972D, H240018521FDD, H24001858B087, H2400193657F5, H24739549A36C, H2473957014C5, H247401821EC1, H247406117747, H247407147A36, H2474074261B8, H24746531E009, H247467227EF2, H2474675675DE, H24750031996A, H24750050DC33, H24750144D913, H247522426A37, H2475230432BD, H24752527E54F, H247587538775, H247626140F14, H24801227575A, H2496106842C6, H249611989BD2, H249632560D1E, H24963287ACEF, H249633015DC5, H24970053C182, H2497182710D7, H249719471EDB, H249720843C33, H249724955703, H249891402382, H24999893363B, H251260919873, H25230803E618, H252308867F75, H25230916F2B1, H25230960DA8F, H252309795E96, H25231040699A, H2523105161CB, H252310650D87, H25231134386A, H252311723A3C, H25233073481F, H252330743CA0, H252330752D29, H252330761FB2, H252330770E3B, H25233078F6CC, H25233083CBD7, H25233084BF68, H25233085AEE1, H25233092C386, H25233094A6B0, H25233095B739, H25233097942B, H252331006D50, H252331060866, H252331107488, H25233112579A, H2523311432AC, H252331170037, H25233119E949, H252331205EE0, H252331214F69, H252331227DF2, H25233125094D, H252331263BD6, H252331272A5F, H25233129C321, H252331304738, H2523313156B1, H2523313375A3, H25233139DAF9, H252331466F06, H25235209546F, H25235233D15D, H2523527084A6, H252353009372, H252353108AAA, H25235326C5F4, H252354246AE3, H25235432160D, H2523547360E4, H252356192ED6, H25235633B23C, H25235651C5FE, H25235661EF96, H252356907DD7, H25235714AFEF, H25390190D706, H25390192F414, H253901949122, H2539019580AB, H25390196B230, H25904803A41D,

    Distribution

    US: None OUS: CH DE DK IT FR IE GB KW QA PL ES AT PH AE SI CZ

    Quantity

    105