BEUDAMED
    FDA Recall Open, Classified

    Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.

    Recall: Z-1615-2026 · Initiated March 2, 2026

    Recall

    Recall Number
    Z-1615-2026
    Event Number
    98537
    Firm
    Philips Respironics, Inc.
    FEI Number
    2518422
    Product Code
    CBK
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 2, 2026
    Posted
    March 26, 2026
    Address
    1001 Murry Ridge Ln, Murrysville, PA, 15668-8517

    Description

    Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.

    Reason

    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.

    Action

    An UPDATED: "URGENT FIELD SAFETY NOTICE" dated 3/2/26 was mailed to consignees containing recall information for three different failure modes that can be experienced in all Trilogy Evo, Trilogy EVO O2, Trilogy Evo Universal, and Trilogy EV300 devices. The firm identified that 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. This can lead to under-delivery of therapy to the patient. Consignees are being instructed to update all devices with software version 1.05.15.00 through the My Philips for Professionals and In Center websites. The provided Appendix B contains the required instructions. Consignees are also instructed to review the latest version of the User Manual Addendum, communicate the safety notice to all in their organization who interact with affect devices, and forward the notice to those who received product that was further distributed. Consignees are to stop all use of non-pneumatic nebulizers, including vibrating mesh nebulizers, with all affected devices. Distributors should notify their customers of this recall with the provided notice and response form. DME and Homecare Customers can contact 1-800-345-6443 (option 2, option 1) for assistance. Hospital Customers can contact 1-800-722-9377 (option 2) for assistance.

    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.

    Quantity

    113,717 units