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Serious riskFDA DeviceClass I

Philips Trilogy Evo ventilator recalled for possible alarm delay

Philips Respironics has recalled certain Trilogy Evo Universal home ventilators (Software Version 1.05.15.00) because the obstruction alarm may not trigger as quickly as safety standards require. In some cases, the alarm could be delayed by up to four breaths, which may prevent timely notification of a breathing tube blockage.

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

What to do

  1. Contact Philips Respironics immediately if you use this ventilator model to learn about a software update or next steps
  2. Do not stop using your ventilator—speak to your doctor or respiratory therapist about safety measures while waiting for instructions
  3. Check your device's software version (1.05.15.00) and serial number against Philips Respironics' recall list
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Philips Respironics Trilogy Evo Universal, 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-1649-2026

In the FDA's words

Description
Philips Respironics Trilogy Evo Universal, 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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