FDA Device recall Z-1287-2023
Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, JP2100X16B, AU21…
- FDA Device
- Class I
- ongoing
- Published 2023-04-12
On 2023-04-12 the FDA classified a Class I recall of Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, JP2100X16B, AU21… by Philips Respironics, citing the accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the inte….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1287-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-03-01 |
| Published | 2023-04-12 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips Respironics |
| Distribution | US |
Product
Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, JP2100X16B, AU2100X15B, LA2100X15B, CA2100X12B, CN2100X17B, BR2100X18B, KR2100X15B, IA2100X15B, PP2100X10, FP2100X10, FR2100X14B, ND2100X15B, IT2100X21B, ES2100X15B, DE2100X13B, BL2100X15B, GB2100X15B, EU2100X15B, EU2100X19, EE2100X15B, TR2100X15B, UDS2100X11B, RDS2100X11B, and SP2100X26B
Reason
The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the device is actually delivering. This may lead to under delivery of oxygen.
Identifiers
| code_info | UDI-DI: 606959051997, 606959054059, 606959055575, 606959061019, 606959055599, 606959055636, 606959062085, 6069…UDI-DI: 606959051997, 606959054059, 606959055575, 606959061019, 606959055599, 606959055636, 606959062085, 606959055643, 606959055650, 606959055438, 606959054097, 606959054103, 606959055674, 606959055681, 606959055698. UDI-DI, Model Number: Serial numbers. 606959054103, DE2100X13B: H236054270DD5, H23630215A1ED, H23630353F967, H23708996882F, H24371560D579, H24762460B180, H24762461A009, H24762464F7A4, H255384963A07, H255386624A53, H25781923C0A4, H2578201604B2, H257820401F3C, H257820445918, H25782086D3AA, H25782201DC6D, H25787261E6EA, H2578730964AE, H25787344D82B, H2578742046DA, H257930337750, H257930373174, H25793039D80A, H25793041194A, H257930433A58, H257930444EE7, H257930477C7C, H25793048848B, H25793050111B, H257930510092, H257930532380, H2579305546B6, H25793056742D, H257930589D53, H257930612AFA, H257930621861, H2579306309E8, H257930656CDE, H257930665E45, H25793068B73B, H257930713322, H2579307201B9, H25793074648F, H257930757506, H25793085F6CE, H257930929BA9, H25 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1287-2023%22
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