Recall Weekly
Serious riskFDA DeviceClass I

Philips Trilogy Evo O2 software recalled for tidal volume risk

Philips Respironics has recalled certain Trilogy Evo O2 home ventilators because using non-pneumatic nebulizers with them may cause a mismatch between the breath volume set on the machine and the volume actually delivered to the patient. This discrepancy could result in the patient receiving too much or too little air during ventilation.

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

What to do

  1. Contact Philips Respironics immediately if you use a Trilogy Evo O2 ventilator with a non-pneumatic nebulizer
  2. Do not use non-pneumatic nebulizers with your Trilogy Evo O2 until you receive guidance from Philips
  3. Ask your doctor or respiratory therapist which nebulizers are safe to use with your ventilator
  4. Check for software updates or instructions from Philips Respironics
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Philips Respironics Trilogy Evo O2, 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-1615-2026

In the FDA's words

Description
Philips Respironics Trilogy Evo O2, 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.

Related topics

OtherSoftwareMedical devicesSold nationwideMore from FDA Device