BEUDAMED
    FDA Enforcement Class I Ongoing

    Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.

    Recall: Z-1648-2026 · Reported April 8, 2026

    Enforcement

    Recall Number
    Z-1648-2026
    Event ID
    98540
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips Respironics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 8, 2026
    Initiation Date
    March 2, 2026
    Classification Date
    April 2, 2026
    Address
    1001 Murry Ridge Ln, Murrysville, PA, 15668-8517, United States

    Description

    Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.

    Reason

    In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.

    Code Info

    All Model No.; All UDI; All Serial No.

    Distribution

    Worldwide Distribution. US Nationwide, 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, Reunion, 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