Trilogy Evo Universal Ventilator — Class I medical device recall Z-1652-2023
Ongoing recall by Philips Respironics, Inc., reported 2023-06-14, distributed nationwide. The Trilogy Evo Universal ventilator provides continuous or intermittent positive pressure ventilation for the
| Recall number | Z-1652-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Respironics, Inc., Murrysville, PA, United States |
| Recall initiated | 2023-05-01 |
| Classified | 2023-06-02 |
| Reported by FDA | 2023-06-14 |
| Distributed | Nationwide (US) |
| Quantity | 22,237 devices |
| UPC / GTIN / UDI-DI | 00277379821790, 00284704647871, 00284744303201, 00285505652187, 00286599273548, 00288518628323, 00288518957454, 00289104647636, 00289834673004, 00289847779199, 00289847835475, 00289948793964, 00291315283558, 00291459326449, 00291783837451, 00291787965945, 00292713423966, 00292980507413, 00293399901595, 00293521738051, 00293521821210, 00293521913953, 00293936443908, 00293937004290, 00293971930326 and 117 more |
| Serial numbers | H27736231F4BE, H277362379188, H27736246CD09, H277372867812, H27737288916C, H2773729661CA, H27737302AA2A, H27737306EC0E, H2773730914F9, H27737331B2D9, H27737344A87C, H277373468B6E, H277373596A41, H277373815671, H2773738401DC, H2773740998FC, H277374132E7E, H277374212704, H277374525897, H277374740E11, H277374848DD9, H27737492F137, H27737496B713, H277375206C51, H277375242A75 and 475 more |
| Model numbers | DS2000X11B |
Product
Trilogy Evo Universal Ventilator, Model Number DS2000X11B
Reason for recall
The Trilogy Evo Universal ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo Universal 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. The ventilator is suitable for use in institutional and hospital settings and non-emergency transport settings; for example, wheelchair. It may be used for both invasive and non-invasive ventilation.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1652-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.