Trilogy Evo Trilogy Evo, PostponementRecalls & reported problems

Respironics, Inc. · Trilogy Evo Ventilator, postponement · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

Oct 7, 2024Open, Classified
Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
Z-0291-2025 · Root cause: Device Design · FDA record ↗

Device details

UDI-DI	`00606959054035`
Brand	Trilogy Evo
Model	Trilogy Evo, Postponement
Catalog no.	PP2110X10
Company	Respironics, Inc.
Product code	CBK · VENTILATOR, CONTINUOUS, FACILITY USE
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 4, 2021

Device type (GMDN): Portable electric ventilator

A portable, electrically-powered device intended to provide long-term alveolar support for patients who do not require complex critical care ventilation. It typically uses positive pressure to deliver gas to the lungs at normal breathing rates and tidal volumes through invasive ventilation (i.e., with an artificial airway); it may also be used non-invasively (e.g., with a mask). It includes a control system and alarms, and may include a built-in humidifier. Several methods of cycling and ventilation modes may be used. It may be line and/or internal/external battery-powered for use in the home or a healthcare facility (including ambulatory).

Other VENTILATOR, CONTINUOUS, FACILITY USE devices

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Trilogy 100 Trilogy 100 W/ Bluetooth, USA
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HAMILTON-C1 161001
Hamilton Medical AG · Ventilator, Continuous, Facility Use
2 recalls12 deaths1,849 reports
Trilogy Trilogy O2 Ventilator Japan
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7 deaths1,900 reports
Trilogy Trilogy 202 Ventilator International
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HAMILTON-C6 160021
Hamilton Medical AG · Ventilator, Continuous, Facility Use
5 recalls10 deaths1,175 reports

All VENTILATOR, CONTINUOUS, FACILITY USE devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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