Trilogy Evo O2 and LifeVent EVO2 — Class I medical device recall Z-1650-2023
Ongoing recall by Philips Respironics, Inc., reported 2023-06-14, distributed nationwide. Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may im
| Recall number | Z-1650-2023 |
|---|---|
| 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 | 21,520 devices |
| Reason classes | device malfunction |
| 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 322 more |
| Serial numbers | H236054270DD5, H23605519941F, H23630215A1ED, H23630353F967, H23708996882F, H23987675BB18, H239876768983, H239876806F7D, H243715497B08, H243715587359, H24371560D579, H24371562F66B, H2476245817A0, H24762460B180, H24762461A009, H247624629292, H24762464F7A4, H255250444AC7, H255250499122, H2552505327A0, H255250576184, H2552506568FE, H255384784969, H255384963A07, H25538501C37C and 475 more |
| Model numbers | DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, EU2100X19, FP2100X10, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B, IN2100X19, IT2100X21B, LA2100X15B, ND2100X15B, SP2100X26B |
Product
Trilogy Evo O2 and LifeVent EVO2, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, LA2100X15B, IA2100X15B, FP2100X10, FR2100X14B, ND2100X15B, IT2100X21B, ES2100X15B, DE2100X13B, EU2100X15B, EU2100X19, EE2100X15B, and SP2100X26B
Reason for recall
Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in patient harm up to hypoxemia if not addressed by the care provider.
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-1650-2023. 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.