The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Product Name: Philips Respironics Trilogy Evo, Trilogy Evo O2, Trilogy EV300, Trilogy Evo Universal
Product Models and Serial Numbers: See Medical Device Recall Database
- Distribution Dates: March 26, 2019 to March 22, 2023
- Devices Recalled in the U.S.: 73,000
- Date Initiated by Firm: March 29, 2023
Philips Respironics Trilogy Evo, Evo O2, EV300, and Evo Universal ventilators provide continuous positive airway pressure (CPAP) and intermittent positive airway pressure breathing support for people who need mechanical ventilation. They are intended for pediatric through adult patients weighing at least 2.5 kg and are used in hospitals and health care settings and for patient nonemergency transport. The Trilogy EV300 and Trilogy Evo may also be used by people requiring mechanical ventilation in their homes.
Reason for Recall
Philips is recalling Trilogy Evo, Evo O2, EV300, and Evo Universal ventilators after detecting dust and dirt from the environment in the air path of some devices. Extended exposure to environmental contaminants such as dust and dirt can lead to buildup that may block air vents and cause the device to stop delivering the right amount of air pressure, or air volume/flow.
If the ventilator fails to provide the right level of breathing support, patients may not receive enough oxygen (hypoventilation) and may experience a build-up of carbon dioxide or other gas pressure, which can lead to serious injury or death.
Philips has received 542 reports about this issue. There are currently two reported injuries and one death.
Who May be Affected
- People who receive breathing support from the affected Trilogy Evo, Evo O2, EV300, and Evo Universal machines.
- Health care providers and in-home caregivers who provide care for patients using Trilogy Evo, Evo O2, EV300, and Evo Universal for breathing support.
What to Do
On April 17, 2023, Philips sent affected customers and patients an Important Product Notice with the following actions:
How to identify affected products
Actions for users to prevent risk to patients
For questions and support, contact your local Philips representative or Philips Respironics Customer Service.
- Home care customers: 1-800-345-6443
- Hospital customers: 1-800-722-9377
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 using the online form or call 1-800-332-1088 for more information on how to mail or fax the form.