Data Foundry

Medical device recalls 2024

Trilogy Evo O2 — Class I medical device recall Z-1503-2024

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 numberZ-1503-2024
Product typeMedical device
ClassificationClass I
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmPhilips Respironics, Inc., Murrysville, PA, United States
Recall initiated2024-03-19
Classified2024-04-17
Reported by FDA2024-04-24
DistributedNationwide (US)
Quantity789 units
UPC / GTIN / UDI-DI00257930621861, 00259615770581, 00262014691128, 00262336530518, 00262609650318, 00275625750511, 00275629769229, 00606959054097, 00606959054103, 00606959055438, 00606959055636, 00606959055643, 00606959055650, 00606959055698, 00800109645405, 00800109808831, 00800109880479, 00800111090149, 00800111180918, 00800111191891, 00800111805248, 00800111926882, 00800112675383, 00800113440874, 00800113505788 and 2 more
Serial numbersH236054105302, H23605519941F, H23605538B626, H23630215A1ED, H236302782ED8, H236305017214, H23677951D33E, H2370896428F5, H23708996882F, H23987672CFA7, H23987674AA91, H239876768983, H239876806F7D, H24371481043C, H243714900C6D, H24371504C78D, H24371560D579, H24371562F66B, H24762460B180, H24762461A009, H24762464F7A4, H255384963A07, H255386624A53, H257816815401, H25781757DB93 and 475 more
Model numbersDE2100X13B, EE2100X15B, ES2100X15B, FR2100X14B, IA2100X15B, IT2100X21B, ND2100X15B

Product

Trilogy Evo O2, 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-1503-2024. 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.