Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B… — Class I medical device recall Z-2942-2024
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-2942-2024 |
|---|---|
| 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 | 00272157691831, 00275384843776, 00277509282903, 00277612816163, 00278026913806, 00278132748125, 00278245353124, 00278934011779, 00279002459066, 00279003964859, 00279063679182, 00279064164106, 00279432871209, 00279792006914, 00280115364888, 00280363383686, 00280364330450, 00280366835540, 00280460722104, 00280521839031, 00280583949440, 00280584008979, 00280584080531, 00280584118128, 00280647178182 and 330 more |
| Serial numbers | H277504071D3B, H277504598AFD, H2775061483C0, H27750906F3CD, H277511623B40, H27990931E388, H27990933C09A, H27990934B425, H279909369737, H28068115E37D, H28068117C06F, H28086487E130, H280912810EBA, H28091329255E, H280914614273, H28091549A757, H28091634DEDE, H28091674B9BE, H280918082EC1, H280918779B3E, H28091945C898, H28092332A798, H2809235587F7, H28092419A6FE, H280924344EAB and 475 more |
Product
Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300; BR2200X18B Trilogy Evo, O2, Brazil EV300; CA2200X12B Trilogy Evo, O2, Canada EV300; DE2200X13B Trilogy Evo, O2, Germany EV300; DS2200X11B Trilogy Evo, O2, USA EV300; DS2200X11B Trilogy Evo, O2, USA EV300; EE2200X15B Trilogy Evo, O2, Eastern Europe EV300; ES2200X15B Trilogy Evo, O2, Spain EV300; EU2200X15B Trilogy Evo, O2, EU EV300; FR2200X14B Trilogy Evo, O2, France EV300; FX2200X15B Trilogy Evo, O2, INT EV300; GB2200X15B Trilogy Evo, O2, Great Britain EV300; IN2200X15B Trilogy Evo, O2, INTL EV300; IT2200X21B Trilogy Evo, O2, Italy EV300; KR2200X15B Trilogy Evo, O2, Korea EV300; ND2200X15B Trilogy Evo, O2, Nordics EV300; TR2200X15B Trilogy Evo, O2, Turkey EV300;
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-2942-2024. 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.