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Serious riskFDA DeviceClass I

Philips Trilogy Evo ventilator recalled for possible delayed alarm

Some Philips Respironics Trilogy Evo home ventilators with Software Version 1.05.15.00 may not sound their 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 a user has to respond to an airway obstruction.

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

What to do

  1. Contact Philips Respironics to check if your device is affected and to discuss next steps
  2. Do not stop using your ventilator without talking to your doctor first
  3. Keep emergency contact information for your respiratory care provider readily available
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 (under 100 years)

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-1646-2026

In the FDA's words

Description
Philips Respironics Trilogy Evo, 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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