Trilogy Evo Universal Ventilator — Class I medical device recall Z-2943-2024
Ongoing recall by Philips Respironics, Inc., reported 2024-09-11, distributed nationwide. Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected venti
| Recall number | Z-2943-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Respironics, Inc., Murrysville, PA, United States |
| Recall initiated | 2024-07-16 |
| Classified | 2024-09-04 |
| Reported by FDA | 2024-09-11 |
| Distributed | Nationwide (US) |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00277379821790, 00284704647871, 00284744303201, 00285505652187, 00286599273548, 00288518628323, 00288518957454, 00289104647636, 00289834673004, 00289847779199, 00289847835475, 00289948793964, 00291315283558, 00291459326449, 00291783837451, 00291787965945, 00292713423966, 00292980507413, 00293399901595, 00293521738051, 00293521821210, 00293521913953, 00293936443908, 00293937004290, 00293971930326 and 117 more |
| Serial numbers | H28984740CF4E, H28984800E2E9, H2941496672BD, H29524514A0E3, H29524529516E, H2952453948B6, H295245481437, H29524560ABCF, H29524573808C, H29524574F433, H295245856672, H2952458654E9, H29639032436E, H2963908084D4, H29639092BE1E, H296391122A02, H2963913219B2, H296391374E1F, H29639144318C, H296391506E70, H296391571ACF, H296391604418, H2963916513B5, H29639178D188, H29639190C7D0 and 475 more |
| Model numbers | DS2000X11B |
Product
Trilogy Evo Universal Ventilator, Model No. DS2000X11B
Reason for recall
Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.
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-2943-2024. 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.