CLASS I Device recall · Reported 26 Feb 2020 · FDA Enforcement Report
Garbin EVO Ventilator, Linde recalled by Philips Respironics
Philips Respironics is recalling Garbin EVO Ventilator, Linde. The recall was initiated on 19 Nov 2019 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0946-2020
- FDA event ID
- 84406
- Recalling firm
- Philips Respironics, Murrysville, PA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 19 Nov 2019
- FDA classified
- 14 Feb 2020
- Reported
- 26 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- CPAP & Ventilators
Timeline
| 19 Nov 2019 | Recall initiated by company | |
| 14 Feb 2020 | Classified by FDA | +87 days |
| 26 Feb 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
US: None OUS: CH DE DK IT FR IE GB KW QA PL ES AT PH AE SI CZ
Questions about this recall
Is Garbin EVO Ventilator, Linde recalled?
Yes. Philips Respironics recalled Garbin EVO Ventilator, Linde on 19 Nov 2019. The recall is Class I and its status is Terminated. Recall number Z-0946-2020.
Why was it recalled?
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.
Which lots are affected?
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,
Where was it sold?
US: None OUS: CH DE DK IT FR IE GB KW QA PL ES AT PH AE SI CZ
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Philips Respironics
All 76| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Trilogy Evo recalled by Philips Respironics | Philips Respironics | Device Malfunction | Nationwide |
| Device | CLASS I | Trilogy EV300 recalled by Philips Respironics | Philips Respironics | Device Malfunction | Nationwide |
| Device | CLASS I | Trilogy Evo Universal recalled by Philips Respironics | Philips Respironics | Device Malfunction | Nationwide |
| Device | CLASS I | Trilogy Evo O2 recalled by Philips Respironics | Philips Respironics | Device Malfunction | Nationwide |
| Device | CLASS I | Trilogy Evo recalled by Philips Respironics | Philips Respironics | Device Malfunction | Nationwide |
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