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Serious riskFDA DeviceClass I

Philips Trilogy Evo recalled for possible tidal volume discrepancy

Philips Respironics has identified an issue with Trilogy Evo ventilators when used with certain non-pneumatic nebulizers. The ventilator may deliver a different amount of air to the patient than the setting shows, which could affect treatment effectiveness. Philips is working with health care providers and regulators on a solution.

From the FDA notice · Read the official notice ↗ · All Philips recalls

What to do

  1. If you use a Trilogy Evo ventilator, contact your respiratory care provider or Philips immediately
  2. Do not switch to a non-pneumatic nebulizer without checking with your provider first
  3. Continue using your ventilator as prescribed while awaiting further guidance
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.
Sold in
Nationwide
Made for
Adults (0 months and older)

This recall covers 4 products — see all of them.

Details

Units affected
113,717 units
Illnesses reported
None reported
Manufactured in
1001 Murry Ridge Ln, Murrysville, PA, United States
Classification
Class I
Recall number
Z-1614-2026

In the FDA's words

Description
Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device. Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient. All Model No.; All UDI; All Serial No. Distribution: Worldwide distribution: US (Nationwide) and OUS (Foreign) to countries of: Argentina, Austria, Australia, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bolivia, Brazil, Bahamas, Canada, Switzerland, Chile, China, Colombia, Czech Republic, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Finland, France, Georgia, French Guiana, Gibraltar, Greece, Guatemala, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Italy, Jersey, Jordan, Japan, Kenya, South Korea, Kuwait, Lebanon, Lithuania, Morocco, Montenegro, North Macedonia, Myanmar, Martinique, Malta, Mexico, Malaysia, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, French Polynesia, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, R¿union, Romania, Serbia, Russia, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Thailand, Tunisia, Turkey, Taiwan, Ukraine, United Arab Emirates, United Kingdom, Vietnam, Mayotte, South Africa, Zimbabwe. Affected quantity: 113,717 units
Hazard
Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.

4 products in this recall

Philips Trilogy Evo ventilators recalled for breath volume risk

Philips is recalling four Trilogy ventilator models running software version 1.05.15.00: Trilogy Evo, Trilogy Evo O2, Trilogy EV300, and Trilogy Evo Universal. When non-pneumatic nebulizers are used with these ventilators, the breath volume the patient receives may differ from the amount the device is set to deliver. No injuries have been reported. The recall covers about 113,717 units per model and was distributed nationwide and in many other countries.

The agency lists each product separately. Check every one you might have.

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