Trilogy Evo — Class II medical device recall Z-2106-2023
Ongoing recall by Philips Respironics, Inc., reported 2023-07-12. There are errors present in the Korean Instructions For Use where the word "invasive," was incorrectly transla
| Recall number | Z-2106-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Respironics, Inc., Murrysville, PA, United States |
| Recall initiated | 2023-05-25 |
| Classified | 2023-07-06 |
| Reported by FDA | 2023-07-12 |
| Countries outside the US | KR |
| Quantity | 1,581 units |
| UPC / GTIN / UDI-DI | 00306661402383, 00306705236677, 00306787635177, 00306832943554, 00306833358371, 00306867186612, 00306870746810, 00312487391220, 00312488480466, 00319617444603, 00320011737888, 00321470405806, 00322989882300, 00322992050338, 00323000610858, 00323000700009, 00325050354669, 00325115489091, 00325188730236, 00325190797715, 00325191295371, 00325191519231, 00325264477857, 00327516924591, 00327517359682 and 6 more |
| Serial numbers | H30665832F44A, H3066588656C6, H306658946C0C, H30665905F041, H306659391045, H30665956BC62, H30665965A491, H306659871D93, H30665993426F, H306660257A22, H306660321745, H30666039A996, H306660506087, H30666058ECCF, H306660637874, H30666068C6A7, H3066608496DB, H30666098456F, H3066612703EC, H306661402383, H30666141320A, H306661420091, H306661431118, H3066614646B5, H30666147573C and 475 more |
Product
Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use
Reason for recall
There are errors present in the Korean Instructions For Use where the word "invasive," was incorrectly translated to "noninvasive".
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-2106-2023. 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.