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Serious riskFDA DeviceClass I

Philips Respironics Trilogy EV300 recalled for tidal volume risk

Philips Respironics has recalled Trilogy EV300 ventilators (software version 1.05.15.00) because using them with certain types of nebulizers can cause the device to deliver a different amount of air to the patient than what was set. This mismatch between the intended and actual breath volume could affect patient safety.

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

What to do

  1. If you use a Trilogy EV300 ventilator at home, contact Philips Respironics or your equipment provider immediately
  2. Do not use non-pneumatic nebulizers with your Trilogy EV300 until you receive guidance from Philips
  3. Ask your provider which nebulizer types are safe to use with your ventilator
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Philips Respironics Trilogy EV300, 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-1616-2026

In the FDA's words

Description
Philips Respironics Trilogy EV300, 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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