Trilogy Evo — Class I medical device recall Z-1649-2023
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-1649-2023 |
|---|---|
| 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 | 57,395 devices |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00236168976257, 00236170100251, 00236172484519, 00248213151274, 00251015473529, 00251250171648, 00251287511394, 00252331134613, 00256914450152, 00257876844836, 00258461356710, 00258925363872, 00259048586476, 00259163837149, 00260467234411, 00260722076718, 00260842606611, 00260927335351, 00261349991279, 00261390150144, 00261523140424, 00262747665830, 00262806886992, 00264083953510, 00264112347112 and 475 more |
| Serial numbers | H236058249AED, H236060230D5D, H2360610056AA, H23606124233E, H23609297A890, H23616302CB44, H23616736C469, H236168976257, H2361712434C1, H23618041DF99, H236182213EF1, H2362414983F5, H236241588BA4, H236263920190, H23626497DA38, H23626795164E, H23626802FF2E, H2362682863C4, H23626844FD78, H236269914071, H236270167AAB, H2362705078FD, H236271027F8B, H2362713613C7, H236283633D93 and 475 more |
| Model numbers | AU2110X15B, BL2110X15B, BR2110X18B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B, EU2110X15B, FP2110X10, FR2110X14B, GB2110X15B, IA2110X15B, IN2110X15B, IT2110X21B, JP2110X16B, KR2110X15B, LA2110X15B, LD2110X23B, ND2110X15B, VT2110X24B |
Product
Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B, CA2110X12B, BR2110X18B, KR2110X15B, IA2110X15B, FP2110X10, FR2110X14B, ND2110X15B, IT2110X21B, ES2110X15B, DE2110X13B, BL2110X15B, GB2110X15B, EU2110X15B, EE2110X15B, LD2110X23B, and VT2110X24B
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-1649-2023. 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.