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Serious riskFDA DeviceClass I

Philips Trilogy Evo O2 ventilator recalled for delayed alarm

Some Philips Respironics Trilogy Evo O2 ventilators with software version 1.05.15.00 may not sound an obstruction alarm quickly enough if the breathing tube becomes blocked. The alarm could be delayed by up to four breaths, which could reduce the time available to respond to a blockage.

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

What to do

  1. If you use this ventilator, contact Philips Respironics immediately for instructions or a software update
  2. Verify your device model number and software version match the recall details
  3. Continue using your ventilator but monitor the obstruction alarm function closely
  4. Ask your respiratory therapist or home care provider to check your device
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-1647-2026

In the FDA's words

Description
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device. In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths. All Model No.; All UDI; All Serial No. Distribution: Domestic: Nationwide Distribution; Foreign: 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
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.

4 products in this recall

Philips Trilogy Evo ventilators recalled for delayed alarm

Philips is recalling four Trilogy ventilator models running Software Version 1.05.15.00, covering 113,717 units in total. In some situations, the Obstruction Alarm does not sound within the time required by applicable standards and may take up to four breaths to trigger. No injuries have been reported.

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

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