FDA Device recall Z-1651-2023
Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, BL2200X15B, GB2200X…
- FDA Device
- Class I
- ongoing
- Published 2023-06-14
On 2023-06-14 the FDA classified a Class I recall of Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, BL2200X15B, GB2200X… 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-1651-2023 |
| 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 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, BL2200X15B, GB2200X15B, EU2200X15B, EE2200X15B, and TR2200X15B
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: 606959052017 606959056497 606959061033 606959052321 606959058613 606959058620 606959058644 606959058668 6069590…UDI-DI: 606959052017 606959056497 606959061033 606959052321 606959058613 606959058620 606959058644 606959058668 606959058675 606959058682 606959058705 606959058798; Serial Numbers: H800088856BDC H800088865947 H80008889A1B0 H800088913420 H8000889206BB H800089218A54 H295004989AF7 H295005081733 H29500526CDFD H29500537C5AC H29500543CE80 H29500550E5C3 H29500557917C H29500562ECB9 H2950058276A9 H29500589C87A H295005940A47 H2950064102F6 H29500644555B H2950064767C0 H295006500AA7 H295006566F91 H295006577E18 H295006599766 H29500695F4AA H295007020DD1 H29500710371B H29500716522D H295007210CFA H2950072769CC H295007333630 H29500748C5EB H29500782C311 H29500785B7AE H29500791E852 H29500808E84C H295008107DDC H2950081618EA H295008304E6C H295008362B5A H295008400364 H2950084554C9 H2950086030D4 H2950086213C6 H29500867446B H295008731B97 H29500878A544 H29500881BB4D H29500883985F H29500885FD69 H295109734A0F H295684188A77 H29568454277B H295684894CE6 H2956852613BD H295702706AAA H295702771E15 H29570309E0BF H29570 |
|---|
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-1651-2023%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.