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  5. Ventilator Software Correction: Philips Respironics Issues Mandatory Software Correction and Updates Use Instructions for Trilogy Evo, EV300, EvoO2, and Evo Universal to Address Multiple Issues that May Impact Ventilation
  1. Medical Device Recalls

Ventilator Software Correction: Philips Respironics Issues Mandatory Software Correction and Updates Use Instructions for Trilogy Evo, EV300, EvoO2, and Evo Universal to Address Multiple Issues that May Impact Ventilation

This recall involves correcting devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.

Affected Product

  • Product Names: 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

What to Do

  • Do not operate Trilogy Evo, EV300, Trilogy Evo O2, or Trilogy Evo Universal ventilators without ensuring that:
    • The ventilator's software has been successfully updated to version 1.05.10.00 (US).
    • The user is aware of the User Manual addendum, which includes:
      • Required use of a Philips approved particulate filter to prevent environmental contamination.

On July 16, 2024, Philips Respironics sent all affected customers an Urgent Medical Device Correction – Update recommending the following actions:

  • Immediately update device software following instructions provided in the letter.
    • The company will follow up to make sure all devices have been updated to Software Version 1.05.10.00 (US).
    •  Separate instructions are available for both DME/ homecare users and hospital users on how to download the software corrections.
  • Follow the instructions in the User Manual addendum that requires the use of a Phillps approved particulate filter to prevent environmental contamination.
  • Review the information in appendix A and B of the letter to make sure all recommended mitigations are followed until software update is complete.
  • Share the updated correction information with everyone who needs to be aware, both within the organization and any place where potentially affected devices may have been transferred.
  • Distributors: Distribute the notification and all relevant appendices to appropriate physicians, clinicians, patients and/or users.

Reason for Correction

Philips Respironics is correcting their Trilogy Evo, Trilogy EV300, Trilogy Evo O2, and Trilogy Evo Universal ventilators using Software Version 1.05.10.00 (US) to resolve several previously reported and also new safety issues that may affect the device's ability to support patient breathing. The issues include:

  • An inaccurate display of oxygen being delivered to the patient where the patient may receive less than is indicated on the screen.
  • A software related issue causing false power loss or battery depleted alarms which may lead to a stoppage of therapy.
  • Flow Sensor Reading Compensation associated with volume measurement inaccuracies
  • Software Alarm Errors (associated with Obstruction Alarm, High and low tidal volume alarms when using A/C-VC mode, Leakage Alarm, AEV Failure Alarm.
  • HIP/LIP - HEP/LEP technical Alarm threshold to eliminate nuisance alarms. 
  • Addition of high priority Vent Service Required alarm criteria to detect contamination on flow sensor mesh.  
  • E110 Vent INOP issue triggered by motor stalls.
  • Spontaneous breath percent calculation.
  • Floating point calculations.
  • Translation strings to avoid confusion for customers.
  • User interface (UI) issues.
  • Adjustment of maximum alarm volume setting to meet standards requirements.
  • Software errors, as well as data corruption and transfer of data with Care Orchestrator (CO) and Care Orchestrator Essence (COE).

Additionally, Philips Respironics is also correcting these devices using the Philips Respironics User Manual addendum, i.e., L1154778b03, Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, & Trilogy EV300 Clinical & Caregiver Manual Addendum) for the previously reported satey issues as below:

  • The accumulation of environmental debris on the internal machine flow sensor, which could partially block pressure, volume, or air flow.
  • Instructions for Use translations in Korean, Spanish and Chines languages.
  • Missing contraindications in the Instructions for Use.

The use of affected products may cause serious adverse health consequences, including a lack of ventilation (hypoventilation), lack of enough oxygen to the organs of the body (hypoxia), and death.

There have been nine reported injuries. There has been one reported death.

Device Use

Philips Respironics Trilogy ventilators provide pressure support, pressure control, or volume control during breathing support. These devices are intended to be used for people who need help with breathing by providing continuous or intermittent breathing support. They are used in medical, home, and non-emergency transport settings, for example a wheelchair, personal vehicle, or ambulance.

Contact Information

Customers in the U.S. with questions about this recall should contact respironics.service.operations@philips.com or their Philips representative at: 1-800-722-9377.

Additional FDA Resources

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

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