Trilogy Evo O2 EV300 — Class I medical device recall Z-1651-2023
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-1651-2023 |
|---|---|
| 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 | 18,855 devices |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00277379821790, 00284704647871, 00284744303201, 00285505652187, 00286599273548, 00288518628323, 00288518957454, 00289104647636, 00289834673004, 00289847779199, 00289847835475, 00289948793964, 00291015191375, 00291137626724, 00291138173746, 00291315283558, 00291459326449, 00291783837451, 00291787965945, 00292713423966, 00292980507413, 00293395071391, 00293396815703, 00293399901595, 00293451669241 and 246 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 | BL2200X15B, CA2200X12B, DS2200X11B, EE2200X15B, ES2200X15B, EU2200X15B, FR2200X14B, FX2200X15B, GB2200X15B, IN2200X15B, ND2200X15B, TR2200X15B |
Product
Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, BL2200X15B, GB2200X15B, EU2200X15B, EE2200X15B, and TR2200X15B
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-1651-2023. 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.