Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator — Class I medical device recall Z-1287-2023
Ongoing recall by Philips Respironics, Inc., reported 2023-04-12, distributed nationwide. The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing h
| Recall number | Z-1287-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Respironics, Inc., Murrysville, PA, United States |
| Recall initiated | 2023-03-01 |
| Classified | 2023-04-03 |
| Reported by FDA | 2023-04-12 |
| Distributed | Nationwide (US) |
| Quantity | 62,826 devices |
| UPC / GTIN / UDI-DI | 00255250499122, 00257724106819, 00257818579154, 00257930621861, 00259615770581, 00259620670029, 00260078354393, 00262014691128, 00262336530518, 00262339471023, 00262341487937, 00262609650318, 00263906020767, 00265074840796, 00273896565209, 00274675204678, 00275437925435, 00275437961211, 00275437970398, 00275625750511, 00275629769229, 00276345363159, 00276345401967, 00276346383743, 00276386066361 and 331 more |
| Serial numbers | 1121530972, 22EE2, 26687445E9E2, 5B2EA, 606959051997, 606959054059, 606959054097, 606959054103, 606959055438, 606959055575, 606959055599, 606959055636, 606959055643, 606959055650, 606959055674, 606959055681, 606959055698, 606959057456, 606959061019, 606959062085, 738381FD7C, DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B and 475 more |
| Model numbers | AU2100X15B, BL2100X15B, BR2100X18B, CA2100X12B, CN2100X17B, DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, EU2100X19, FP2100X10, FR2100X14B, FX2100X15B, GB2100X15B, IA2100X15B, IN2100X15B, IN2100X19, IT2100X21B, JP2100X16B, KR2100X15B, LA2100X15B, ND2100X15B, PP2100X10, RDS2100X11B and 3 more |
Product
Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, JP2100X16B, AU2100X15B, LA2100X15B, CA2100X12B, CN2100X17B, BR2100X18B, KR2100X15B, IA2100X15B, PP2100X10, FP2100X10, FR2100X14B, ND2100X15B, IT2100X21B, ES2100X15B, DE2100X13B, BL2100X15B, GB2100X15B, EU2100X15B, EU2100X19, EE2100X15B, TR2100X15B, UDS2100X11B, RDS2100X11B, and SP2100X26B
Reason for recall
The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the device is actually delivering. This may lead to under delivery of oxygen.
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-1287-2023. 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.