Philips Enhances Trilogy Ventilators with Software Correction for Improved Performance

Philips Enhances Trilogy Ventilators with Software Correction for Improved Performance

This recall pertains to modifications made to devices and does not entail their removal from locations where they are utilized or sold. The FDA categorizes this recall as the most serious kind, as the device poses a risk of significant injury or fatality if usage continues without necessary rectifications.

Product Details

  • Product Titles: Trilogy Evo, Trilogy EV300, Trilogy Evo O2, Trilogy Evo Universal
  • Unique Device Identifier (UDI)/Model: 00606959051942/Trilogy Evo, 00606959052017/Trilogy EV300, 00606959061019/Trilogy Evo O2, 00606959052000/Trilogy Evo Universal

Action Steps

  • Do not use the Trilogy Evo, EV300, Trilogy Evo O2, or Trilogy Evo Universal ventilators until:
    • The ventilator software is updated to version 1.05.10.00 (US).
    • The user has acknowledged the User Manual addendum, which contains:
      • The mandatory use of a Philips approved particulate filter to avoid contamination from the environment.

On July 16, 2024, Philips Respironics informed all impacted customers via an Urgent Medical Device Correction – Update, advising the following:

  • Promptly execute the device software update as directed in the letter.
    • Philips will follow up to confirm all devices are updated to Software Version 1.05.10.00 (US).
    • Distinct instructions for DME/homecare users and hospital users regarding software downloading are available.
  • Adhere to the guidelines in the User Manual addendum regarding the required use of a Philips approved particulate filter.
  • Examine the content in appendices A and B of the letter to guarantee compliance with all recommended actions until the software update is finalized.
  • Communicate the updated correction information to all relevant personnel, whether in the organization or to places where the possibly affected devices may have been moved.
  • Distributors: Ensure distribution of the notification and all relevant appendices to the appropriate physicians, clinicians, patients, and/or users.

Purpose of the Correction

Philips Respironics is rectifying issues in their Trilogy Evo, Trilogy EV300, Trilogy Evo O2, and Trilogy Evo Universal ventilators by updating to Software Version 1.05.10.00 (US) due to several previously documented and new safety concerns that could jeopardize the device’s functionality for patient support. The concerns include:

  • Incorrect indication of oxygen levels delivered to the patient resulting in the possibility of lower delivery than displayed.
  • A software-related issue triggering false power or battery depleted alerts which may interrupt therapy.
  • Inaccurate volume measurement due to flow sensor reading compensation.
  • Errors in software alarms associated with various alarm conditions including high-leakage, etc.
  • Refinement of alarm thresholds to minimize false alerts.
  • High priority Vent Service Required alerts for detecting sensor contamination.
  • Other software-related adjustments and enhancements to user interface (UI).

Moreover, Philips Respironics will employ the User Manual addendum, L1154778b03, addressing previously reported safety issues such as:

  • Environmental debris accumulation affecting internal machine flow sensors, potentially restrict airflow.
  • Missing translations of instructions for use in Korean, Spanish, and Chinese.
  • Omitted contraindications in the Instructions for Use.

Failure to rectify these issues may result in severe health consequences, including inadequate ventilation, insufficient oxygenation (hypoxia), or even fatality.

To date, there have been nine reported injuries and one reported death.

Device Functionality

The Trilogy ventilators by Philips Respironics provide essential breathing support through pressure assistance, pressure control, or volume control. These devices are suitable for individuals needing breathing aid, and can be deployed in medical, home, or non-emergency transportation scenarios.

Contact Details

Users in the U.S. seeking additional information regarding this recall may contact respironics.service.operations@philips.com or reach out to Philips at: 1-800-722-9377.

FDA Additional Resources

  • Summaries of related FDA recall classifications:
  • FDA’s Enforcement Report:
  • Medical Device Recall Database:

Unique Device Identifier (UDI)

The unique device identifier (UDI) serves to track individual medical devices sold within the United States from production to patient use, enabling enhanced reporting and analysis of adverse events for prompt problem identification and resolution.

Reporting Issues

Health professionals and consumers can report adverse reactions or quality concerns encountered with these devices through MedWatch: The FDA Safety Information and Adverse Event Reporting Program.