FDA Device recall Z-2944-2024
Trilogy Evo
- FDA Device
- Class I
- ongoing
- Published 2024-09-11
On 2024-09-11 the FDA classified a Class I recall of Trilogy Evo by Philips Respironics, citing firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier rec….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2944-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-07-16 |
| Published | 2024-09-11 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips Respironics |
| Distribution | US |
Product
Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2110X18B Trilogy Evo, Brazil CA2110X12B Trilogy Evo, Canada DE2100X13B Trilogy Evo O2, Germany DE2110X13B Trilogy Evo, Germany DS2100X11B Trilogy Evo, O2, USA DS2110X11B Trilogy Evo, USA DS2110X11B Trilogy Evo, USA EE2100X15B Trilogy Evo O2, Eastern Europe EE2110X15B Trilogy Evo, Eastern Europe ES2100X15B Trilogy Evo O2, Iberia ES2110X15B Trilogy Evo, Iberia EU2100X15B Trilogy Evo, O2, EU EU2100X19 Trilogy Evo, O2, EU (Non-BT) EU2110X15B Trilogy Evo, EU EU2110X19 Trilogy Evo, EU (Non-BT) FR2100X14B Trilogy Evo O2, France FR2110X14B Trilogy Evo, France FX2100X15B Trilogy Evo, O2, INT GB2110X15B Trilogy Evo, Great Britain IA2100X15B Trilogy Evo O2, India IA2110X15B Trilogy Evo, India IN2100X15B Trilogy Evo, O2, International IN2100X19 Trilogy Evo, O2, International (Non-BT) IN2110X15B Trilogy Evo, International IT2100X21B Trilogy Evo O2, Italy IT2110X21B Trilogy Evo, Italy JP2100X16B Trilogy Evo, O2, Japan JP2110X16B Trilogy Evo, Japan KR2110X15B Trilogy Evo, Korea LA2100X15B Trilogy Evo, O2, Latin America LA2110X15B Trilogy Evo, Latin America LD2110X23B Garbin Evo, Linde ND2100X15B Trilogy Evo O2, Nordics ND2110X15B Trilogy Evo, Nordics RDS2110X11B Trilogy Evo, USA-Rental SP2100X26B LifeVentEVO2 TR2110X15B Trilogy Evo, Turkey UDS2110X11B Trilogy Evo, USA-RECERT VT2110X24B Aeris EVO
Reason
Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.
Identifiers
| code_info | Model Description/ UDI-DI-- Trilogy Evo, Australia 606959051980; Trilogy Evo, Benelux 606959055520; Trilogy Evo, Brazil…Model Description/ UDI-DI-- Trilogy Evo, Australia 606959051980; Trilogy Evo, Benelux 606959055520; Trilogy Evo, Brazil 606959055476; Trilogy Evo, Canada 606959052307; Trilogy Evo O2, Germany 606959054103; Trilogy Evo, Germany 606959054110; Trilogy Evo, O2, USA 606959051997; Trilogy Evo, USA 606959051942; Trilogy Evo, USA 606959051942; Trilogy Evo O2, Eastern Europe 606959055698; Trilogy Evo, Eastern Europe 606959055544; Trilogy Evo O2, Iberia 606959054097; Trilogy Evo, Iberia 606959054080; Trilogy Evo, O2, EU 606959055674; Trilogy Evo, O2, EU (Non-BT) 606959055681; Trilogy Evo, EU 606959054981; Trilogy Evo, EU (Non-BT) 606959055537; Trilogy Evo O2, France 606959055643; Trilogy Evo, France 606959055506; Trilogy Evo, O2, INT 606959061019; Trilogy Evo, Great Britain 606959054127; Trilogy Evo O2, India 606959055636; Trilogy Evo, India 606959055490; Trilogy Evo, O2, International 606959054059; Trilogy Evo, O2, International (Non-BT) 606959055575; Trilogy Evo, International 606959051959; Tr |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2944-2024%22
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