Trilogy EVO Ventilator — Class I medical device recall Z-0945-2020
Terminated recall by Philips Respironics, Inc., reported 2020-02-26. Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, S
| Recall number | Z-0945-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Respironics, Inc., Murrysville, PA, United States |
| Recall initiated | 2019-11-19 |
| Classified | 2020-02-14 |
| Reported by FDA | 2020-02-26 |
| Terminated | 2021-03-31 |
| Quantity | 48 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00236170100251 |
| Serial numbers | H23570360C0F9, H236165266809, H236170100251, H2362652456D7, H2367778607E2, H23678062E52A, H247381064321, H24739273AA5B, H2473940554BC, H24752480365C, H2475250390DB, H24752553EE63, H247525835E1B, H247526530107, H247526623AE6, H24752695CD91, H247588091C50, H247588393638, H24758951B47C, H24762622404A, H249175049E81, H249175058F08, H24917512E26F, H24917524AD31, H24917525BCB8 and 23 more |
| Model numbers | EU2110X15B |
Product
Trilogy EVO Ventilator, EU - Model Number: EU2110X15B 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 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.
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-0945-2020. 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.