Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B… — Class II medical device recall Z-0638-2024
Ongoing recall by Philips Respironics, Inc., reported 2024-01-10, distributed nationwide. The following was missing from the Contraindications Statement: The AVAPS-AE therapy mode is contraindicated f
| Recall number | Z-0638-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Respironics, Inc., Murrysville, PA, United States |
| Recall initiated | 2023-11-27 |
| Classified | 2024-01-04 |
| Reported by FDA | 2024-01-10 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00606959051942, 00606959051959, 00606959051973, 00606959051997, 00606959052307, 00606959054059, 00606959054080, 00606959054097, 00606959054103, 00606959054110, 00606959054127, 00606959054981, 00606959055421, 00606959055438, 00606959055452, 00606959055476, 00606959055483, 00606959055490, 00606959055506, 00606959055513, 00606959055520, 00606959055544, 00606959055575, 00606959055582, 00606959055599 and 8 more |
Product
Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13B DE2110X13B DS2100X11B DS2110X11B EE2100X15B EE2110X15B ES2100X15B ES2110X15B EU2100X15B EU2100X19 EU2110X15B FR2100X14B FR2110X14B FX2100X15B GB2110X15B IA2100X15B IA2110X15B IN2100X15B IN2100X19 IN2110X15B IT2100X21B IT2110X21B JP2100X16B JP2110X16B KR2110X15B LA2100X15B LA2110X15B ND2110X15B RDE2100X13B RDE2110X13B RDS2110X11B RIN2100X15B RIN2110X15B RJP2100X16B RJP2110X16B UDS2110X11B
Reason for recall
The following was missing from the Contraindications Statement: The AVAPS-AE therapy mode is contraindicated for invasive use and patients less than 10 kg. The AVAPS feature is contraindicated for patients less than 10 kg. Potential harms if devices are used on contraindicated patients include barotrauma, hypoventilation/hypercapnia, and rebreathing of excessive CO2.
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-0638-2024. 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.