FDA Device recall Z-1650-2023
Trilogy Evo O2 and LifeVent EVO2, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, LA2100X15B, IA2100X15B, FP2100X10, FR2100X14…
- FDA Device
- Class I
- ongoing
- Published 2023-06-14
On 2023-06-14 the FDA classified a Class I recall of Trilogy Evo O2 and LifeVent EVO2, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, LA2100X15B, IA2100X15B, FP2100X10, FR2100X14… by Philips Respironics, citing environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction ca….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1650-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-05-01 |
| Published | 2023-06-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips Respironics |
| Distribution | US |
Product
Trilogy Evo O2 and LifeVent EVO2, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, LA2100X15B, IA2100X15B, FP2100X10, FR2100X14B, ND2100X15B, IT2100X21B, ES2100X15B, DE2100X13B, EU2100X15B, EU2100X19, EE2100X15B, and SP2100X26B
Reason
Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in patient harm up to hypoxemia if not addressed by the care provider.
Identifiers
| code_info | UDI-DI: 606959051997 606959054059 606959055575 606959061019 606959055599 606959055636 606959062085 606959055643 6069590…UDI-DI: 606959051997 606959054059 606959055575 606959061019 606959055599 606959055636 606959062085 606959055643 606959055650 606959055438 606959054097 606959054103 606959055674 606959055681 606959055698 606959057456; Serial Numbers: 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 H25958981A273 H25960485E33C H259605245519 H259838090646 H260429505975 H26079674BBFF H262014691128 H26201588C06D H262017323 |
|---|
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-1650-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.