Trilogy EvoRecalls & reported problems across all models

We found 20 models of Trilogy Evo by Respironics, Inc. in the FDA's device registry (GUDID). Together they are named in 5,473 adverse event reports in the FDA's MAUDE database, received between Sep 9, 2020 and Sep 30, 2026 — classified as 61 deaths, 42 injuries, 5,370 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (2,229 reports).

12 FDA recall records name at least one of these models by its device identifier, 12 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Trilogy Evo recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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-0291-2025 · Root cause: Device Design · names 12 of these models · Recall details · FDA record ↗

2. 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 · names 7 of these models · Recall details · FDA record ↗

3. 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 · names 18 of these models · Recall details · FDA record ↗

4. 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-1504-2024 · Root cause: Device Design · names 11 of these models · Recall details · FDA record ↗

5. 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 · names 4 of these models · Recall details · FDA record ↗

6. 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 · names 3 of these models · Recall details · FDA record ↗

7. 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 · names 14 of these models · Recall details · FDA record ↗

8. May 25, 2023Open, Classified

   There are errors present in the Korean Instructions For Use where the word "invasive," was incorrectly translated to "noninvasive".

   Z-2106-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

9. 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 · names 3 of these models · Recall details · FDA record ↗

10. 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-1649-2023 · Root cause: Under Investigation by firm · names 4 of these models · Recall details · FDA record ↗

11. 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 · names 7 of these models · Recall details · FDA record ↗

12. Dec 22, 2021Open, Classified

    Philips has identified a specific lot of non-conforming material manufactured by one of its suppliers. A Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) sound abatement foam, a non-conforming material in the devices and repair kits. PE-PUR foam may degrade into particles which may enter the device s air pathway and be ingested or inhaled by the user. The foam degradation may be exacerbated by use of unapproved cleaning methods such as unapproved ozone cleaners, and the PE-PUR foam may off-gas certain chemicals during initial use of the device.

    Z-0493-2022 · Root cause: Mixed-up of materials/components · names 2 of these models · Recall details · FDA record ↗

Most reported Trilogy Evo problems

Trilogy Evo models

20 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Trilogy Evo Trilogy Evo, USA

  Ventilator, continuous, facility use
  6 recalls50 deaths4,393 reports
• Trilogy Evo KR2110X15B

  Ventilator, continuous, facility use
  6 recalls3 deaths466 reports
• Trilogy Evo GB2110X15B

  Continuous, ventilator, home use
  5 recalls1 death141 reports
• Trilogy Evo FX2100X15B

  Continuous, ventilator, home use
  5 recalls1 death128 reports
• Trilogy Evo EE2110X15B

  Continuous, ventilator, home use
  5 recalls1 death85 reports
• Trilogy Evo FR2110X14B

  Ventilator, continuous, facility use
  5 recalls77 reports
• Trilogy Evo DS2100X11B

  Oximeter
  6 recalls2 deaths15 reports
• Trilogy Evo EE2100X15B

  Continuous, ventilator, home use
  6 recalls5 reports
• Trilogy Evo Trilogy Evo Ventilator with oxygen blending model, Germany

  ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
  5 recalls9 reports
• Trilogy Evo Trilogy Evo, O2, India

  Ventilator, continuous, facility use
  5 recalls2 reports
• Trilogy Evo ND2100X15B

  Ventilator, continuous, facility use
  5 recalls0 reports
• Trilogy Evo EU2100X19

  ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
  5 recalls0 reports
• Trilogy Evo ND2110X15B

  Continuous, ventilator, home use
  4 recalls37 reports
• Trilogy Evo BL2110X15B

  ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
  4 recalls28 reports
• Trilogy Evo CA2110X12B

  Ventilator, continuous, facility use
  4 recalls23 reports
• Trilogy Evo AU2110X15B

  Ventilator, continuous, facility use
  3 recalls3 deaths54 reports
• Trilogy Evo TR2110X15B

  Ventilator, continuous, facility use
  3 recalls9 reports
• Trilogy Evo EU2110X19

  Continuous, ventilator, home use
  3 recalls0 reports
• Trilogy Evo Trilogy Evo, Postponement

  VENTILATOR, CONTINUOUS, FACILITY USE
  1 recall0 reports
• Trilogy Evo FX2110X15B

  Continuous, ventilator, home use
  1 report

Recent Trilogy Evo adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Circuit Failure; Electrical /Electronic Property Problem; Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952648 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952644 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952153 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem; Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951679 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem

  The manufacturer received a report that a Trilogy EVO ventilator was returned for service. No patient harm or injury was reported.The device was evaluated at a third-party service center. The device log files were successfully downloaded and reviewed in full. Review of the logs identified a Vent Service Required error indicating that the device software detected a large pressure drop between the monitor and outlet pressure sensors. The air pathway was inspected for environmental debris and contamination; no debris or contamination was identified. Service documentation did not identify the component replaced to address this condition. Additional error conditions, unrelated to the reported malfunction, were identified during the evaluation. An error related to the machine flow sensor offset being greater than 0.2 SLPM was identified. In accordance with the service manual, the machine flow sensor was replaced.An error related to the main outlet pressure sensor encountering an error condition was also identified requiring replacement of the System Printed Circuit Assembly (PCA).An error related to the sensor offset during drift calculation being too high was identified. A pneumatic gro

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951013 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem

  The manufacturer received information alleging a power v_bus dropped error code had occurred on a Trilogy EVO device. The device was not in use on a patient at the time of the occurrence. During the evaluation it was noted that an error code, event power vbus dropped, was observed on the device's error log. The third-party service technician provided no documentation stated on a root cause and/or any component replacement to resolve the event power vbus dropped error code. Another error code, event soft power fail, was observed on the device's error log. The third-party service technician provided no documentation stated on a root cause and/or any component replacement to resolve the event soft power fail error code. There was no repair information was provided, and no part(s) were replaced to address this issue. The root cause isn't confirmed at this time.A final report is being submitted. If new information becomes available following the completion of the device repair that changes the outcome of the investigation and associated medical device reporting a supplemental report will be completed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951010 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem

  The manufacturer received information alleging a power v_bus dropped error code had occurred on a Trilogy EVO device. The device was not in use on a patient at the time of the occurrence. During the evaluation it was noted that an error code, event power vbus dropped, was observed on the device's error log. The third-party service technician provided no documentation stated on a root cause and/or any component replacement to resolve the event power vbus dropped error code. Another error code, event soft power fail, was observed on the device's error log. The third-party service technician provided no documentation stated on a root cause and/or any component replacement to resolve the event soft power fail error code. There was no repair information was provided, and no part(s) were replaced to address this issue due to the customer request to scrap the device. The root cause isn't confirmed at this time.A final report is being submitted. If new information becomes available following the completion of the device repair that changes the outcome of the investigation and associated medical device reporting a supplemental report will be completed. Additionally, during the service of th

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949243 ↗
• MalfunctionSep 30, 2026Battery Problem

  The manufacturer received information that a Trilogy Evo ventilator was returned to a third-party service center for evaluation. There was no patient involvement, and no harm or injury reported.On device evaluation, the internal lithium-ion battery was found to be defective and requiring replacement.Additional findings not related to the malfunction/issue: The flow sensor was due for replacement per FCO0000003. There was no report of a flow sensor failure on evaluation. The detachable battery was found to be defective on evaluation, requiring replacement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947331 ↗
• MalfunctionSep 30, 2026Circuit Failure; Electrical /Electronic Property Problem; Failure to Power Up

  A Trilogy EVO ventilator was returned to the manufacturer's service center for evaluation. There was no harm or injury reported. During the evaluation a Ventilator Inoperative alarm was observed and the device failed to power on. There was no documentation of the alarm observed and no downloaded event log for review. The device's System PCA and System Board to FiO2 Sensor Cable were replaced to address the issues. In addition, rust was observed on the System PCA Fio2 Sensor Cable. The device was tested and passed all final testing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945979 ↗
• MalfunctionSep 30, 2026Circuit Failure; Electrical /Electronic Property Problem

  A Trilogy EVO ventilator was returned to the manufacturer's service center for evaluation. There was no harm or injury reported. During the evaluation, a Ventilator Inoperative alarm was observed indicating data in EEPROM was corrupt on the System/CPU. The System Printed Circuit Assembly (PCA) needed to be replaced to correct the issue. A final report is being submitted. If new information becomes available that changes the outcome of the investigation, a follow up/supplemental report will be completed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945584 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem; Failure to Recalibrate; Infusion or Flow Problem

  A Trilogy EVO ventilator was returned to a third-party service center for service due to FSN 2024-CC_SRC_013. During the evaluation the device failed testing for Flow Verification: Positive Flow: Measured Tidal Volume and Flow Verification: Negative Flow: Measured Tidal Volume. However, the device passed the pneumatic test. The device evaluation does not identify any specific component malfunction that would need to be replaced to resolve the failed test steps, but it does confirm that the device was corrected. The device was corrected, retested and passed the final test.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943602 ↗
• MalfunctionSep 29, 2026Failure to Calibrate

  A Trilogy EVO was returned to a third-party service center for evaluation. There was no harm or injury reported. There was no evidence the device was in patient use. During the evaluation the device failed the positive and negative flow verification test steps. There was no documentation of any components replaced for this issue. The device was retested and passed all final testing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937519 ↗
• MalfunctionSep 29, 2026Circuit Failure; Mechanical Problem; Failure to Power Up

  A Trilogy EVO was returned to the manufacturer's service center for evaluation. There was no harm or injury reported. During the evaluation a ventilator inoperative alarm condition was observed and the device failed to power on. There was documentation of the alarm observed and no downloaded event log for review. The device's system board and system board to FiO2 sensor cable were replaced to address the issues. There was rust observed on the cable. The device logs were not available; therefore, the date of the most recent ventilator inoperative occurrence could not be determined. Accordingly, the date the device was evaluated has been used as the event date for reporting purposes. At this time, the reported ventilator inoperative event is based solely on the customer's allegation and has not been confirmed through device evaluation. The device was tested and passed all final testing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937517 ↗
• MalfunctionSep 28, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50922505 ↗
• MalfunctionSep 25, 2026No Display/Image

  A Trilogy EVO was returned to the manufacturer's service center for evaluation. There was no harm or injury reported. The device was not in patient use. During the evaluation the device's display was found to be damaged and unable to be viewed. The device's display was replaced to address the issue. There were no actionable errors noted. The device was tested and passed all final testing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900871 ↗

Other Respironics, Inc. products

• REMstar System One 60 Series92 models · 37,934 reports
• Philips Trilogy Ventilator90 models · 36,113 reports · 22 recalls
• Philips DreamStation190 models · 32,422 reports
• Trilogy46 models · 21,644 reports · 11 recalls
• Trilogy 1008 models · 5,088 reports
• BiPAP System One 60 Series40 models · 4,599 reports
• BiPAP A4037 models · 1,606 reports · 3 recalls
• BiPAP autoSV Advanced System One 60 Series19 models · 1,166 reports