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Trilogy Evo EU2100X19Recalls & reported problems

Respironics, Inc. · Trilogy Evo, O2, EU (Non-BT) · 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

  1. 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 ↗

  2. 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 ↗

  3. 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-1502-2024 · Root cause: Device Design · Recall details · FDA record ↗

  4. Nov 27, 2023Open, Classified

    The following was missing from the Contraindications Statement: The AVAPS-AE therapy mode is contraindicated for invasive use and patients less than 10 kg. The AVAPS feature is contraindicated for patients less than 10 kg. Potential harms if devices are used on contraindicated patients include barotrauma, hypoventilation/hypercapnia, and rebreathing of excessive CO2.

    Z-0638-2024 · Root cause: Device Design · Recall details · FDA record ↗

  5. 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 ↗

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Sources and updates

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