Trilogy EV300 — Class I medical device recall Z-1502-2024
Ongoing recall by Philips Respironics, Inc., reported 2024-04-24, distributed nationwide. Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has suffici
| Recall number | Z-1502-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Respironics, Inc., Murrysville, PA, United States |
| Recall initiated | 2024-03-19 |
| Classified | 2024-04-17 |
| Reported by FDA | 2024-04-24 |
| Distributed | Nationwide (US) |
| Quantity | 56,012 units |
| UPC / GTIN / UDI-DI | 00606959051997, 00606959052017, 00606959052321, 00606959054059, 00606959055575, 00606959055582, 00606959055599, 00606959055674, 00606959055681, 00606959056497, 00606959058583, 00606959058590, 00606959058613, 00606959058620, 00606959058637, 00606959058644, 00606959058651, 00606959058668, 00606959058675, 00606959058682, 00606959058705, 00606959058798, 00606959061019, 00606959061033 |
| Model numbers | BL2200X15B, BR2200X18B, CA2200X12B, DE2200X13B, DS2100X11B, DS2200X11B, EE2200X15B, ES2200X15B, EU2100X15B, EU2100X19, EU2200X15B, FR2200X14B, FX2100X15B, FX2200X15B, GB2200X15B, IN2100X15B, IN2100X19, IN2200X15B, IT2200X21B, JP2100X16B, KR2200X15B, LA2100X15B, ND2200X15B, TR2200X15B |
Product
Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Reason for recall
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
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-1502-2024. 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.