Trilogy Evo Universal DS2000X11BRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00606959052000), received between Sep 29, 2021 and Feb 16, 2023 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Failure to Recalibrate” (6 reports).

6 FDA recall records name this device's identifier, 6 still open.

8 other recalls cover devices cleared under the same FDA submission (K181170); they may or may not involve this specific model.

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

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-0292-2025 · Root cause: Device Design · 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-2943-2024 · Root cause: Device Design · 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-1505-2024 · Root cause: Device Design · FDA record ↗

4. May 1, 2023Open, Classified

   The Trilogy Evo Universal ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo Universal is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and pulse rate data when integrated with the appropriate accessories. The ventilator is suitable for use in institutional and hospital settings and non-emergency transport settings; for example, wheelchair. It may be used for both invasive and non-invasive ventilation.

   Z-1652-2023 · Root cause: Under Investigation by firm · 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-1288-2023 · Root cause: Under Investigation by firm · FDA record ↗

6. 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-1289-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2023Device Alarm System; Device Alarm System

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS ALARMING FOR REBREATHING. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16389315 ↗
• MalfunctionJan 10, 2023Failure to Recalibrate; Failure to Recalibrate

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "VENTILATOR INOPERATIVE" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG AND THE DEVICE FAILED A TEST STEP DURING TESTING. THE DEVICE'S SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16134116 ↗
• MalfunctionJan 4, 2023Circuit Failure; Failure to Recalibrate; Circuit Failure; Failure to Recalibrate

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG AND FAILED A TEST STEP DURING TESTING. THE DEVICE'S SYSTEM BOARD NEEDS TO BE REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16097497 ↗
• MalfunctionJan 3, 2023Mechanical Problem; Mechanical Problem

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "VENTILATOR SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S OXYGEN BLENDING MODULE HARNESS WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16089950 ↗
• MalfunctionJan 3, 2023Mechanical Problem; Failure to Recalibrate; Mechanical Problem; Failure to Recalibrate

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "VENTILATOR SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S OXYGEN BLENDING MODULE HARNESS WAS REPLACED TO ADDRESS THE ISSUE. DURING THE EVALUATION OF THE DEVICE FAILED A TEST STEP DURING TESTING. THE DEVICE'S SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16089856 ↗
• MalfunctionOct 14, 2022Failure to Recalibrate; Failure to Recalibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR FAILED A TEST STEP DURING TESTING. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15610182 ↗
• MalfunctionOct 5, 2022Application Program Problem; Application Program Problem

  A VENTILATOR WAS EVALUATED BY THE CUSTOMER. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE VENTILATOR AT THE CUSTOMER'S FACILITY, A VENTILATOR INOPERATIVE CONDITION OCCURRED. THE VENTILATOR'S SOFTWARE WAS RE-LOADED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15541894 ↗
• MalfunctionJul 14, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15014727 ↗
• MalfunctionJul 14, 2022No Display/Image; No Display/Image

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A FAILURE OF THE DEVICE'S LCD SCREEN WAS OCCURRED. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15014709 ↗
• MalfunctionDec 1, 2021Failure to Recalibrate; Failure to Recalibrate

  A VENTILATOR WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR EVALUATION. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE VENTILATOR AT THE THIRD PARTY SERVICE CENTER, THE DEVICE FAILED A TEST STEP DURING TESTING. THE MACHINE FLOW SENSOR NEEDS TO BE REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12907406 ↗
• MalfunctionNov 4, 2021Alarm Not Visible; Circuit Failure; Alarm Not Visible; Circuit Failure

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE WITH A VENTILATOR'S VISUAL ALARM INDICATORS DURING INITIAL SET UP. THE DEVICE WAS NOT IN PATIENT USE. THE MANUFACTURER IS CURRENTLY INVESTIGATING THIS ISSUE AND A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12751705 ↗
• MalfunctionSep 29, 2021Failure to Recalibrate; Insufficient Device Problem Information; Failure to Recalibrate; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR FAILED TESTING. THERE WAS NO HARM OR INJURY REPORTED. THE MANUFACTURER IS CURRENTLY INVESTIGATING THIS ISSUE AND A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12548047 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K181170. One submission often covers many models, so check the product and lot details in each record.

• Z-1617-2026 · Mar 2, 2026 · Open, Classified
  Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
• Z-1649-2026 · Mar 2, 2026 · Open, Classified
  Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
• Z-2944-2024 · Jul 16, 2024 · Open, Classified
  Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2110X18B Trilogy Evo, Brazil CA2110X12B Trilogy Evo, Canada DE2100
• Z-2942-2024 · Jul 16, 2024 · Open, Classified
  Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300; BR2200X18B Trilogy Evo, O2, Brazil EV300; CA2200X12B Trilogy Evo, O2, Canada EV300;
• Z-1504-2024 · Mar 19, 2024 · Open, Classified
  Trilogy Evo, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
• Z-0494-2022 · Dec 22, 2021 · Open, Classified
  Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for
• Z-0493-2022 · Dec 22, 2021 · Open, Classified
  Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care o
• Z-2290-2021 · Jul 26, 2021 · Open, Classified
  Trilogy Evo Universal, Product number DS2000X11B