Trilogy Evo ND2100X15BRecalls & reported problems

Respironics, Inc. · Trilogy Evo, O2, Nordics · Class 2

All models of Philips Trilogy Ventilator (90) · Trilogy Evo (20)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

5 open recalls name 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: 5

Summary

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

5 FDA recall records name this device's identifier, 5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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-0290-2025 · Root cause: Device Design · Recall details · FDA record ↗
Jul 16, 2024Open, Classified
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.
Z-2944-2024 · Root cause: Device Design · Recall details · FDA record ↗
Mar 19, 2024Open, Classified
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
Z-1503-2024 · Root cause: Device Design · Recall details · FDA record ↗
May 1, 2023Open, Classified
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.
Z-1650-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Mar 1, 2023Open, Classified
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.
Z-1287-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Device details

UDI-DI	`00606959055650`
Brand	Trilogy Evo
Model	ND2100X15B
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	Jul 6, 2020

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

Trilogy Trilogy100 Ventilator, United States
Respironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE
92 deaths8,161 reports
Trilogy Evo Trilogy Evo, USA
Respironics, Inc. · Ventilator, continuous, facility use
6 recalls50 deaths4,393 reports
Trilogy 100 Trilogy 100 W/ Bluetooth, USA
Respironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE
65 deaths4,569 reports
CARESCAPE R860
Datex-Ohmeda Inc · VENTILATOR, CONTINUOUS, FACILITY USE
1 recall1 death4,346 reports
HAMILTON-C1 161001
Hamilton Medical AG · Ventilator, Continuous, Facility Use
2 recalls12 deaths1,849 reports
Trilogy Trilogy O2 Ventilator Japan
Respironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE
7 deaths1,900 reports
Trilogy Trilogy 202 Ventilator International
Respironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE
11 deaths1,564 reports
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 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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