FDAFDA · Food and drugs·Recall number Z-0946-2020
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.
Published February 26, 2020 · Recall initiated: November 19, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Respironics, Inc.
- Distributor
- US: None OUS: CH DE DK IT FR IE GB KW QA PL ES AT PH AE SI CZ
- Lot
- 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,
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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