BEUDAMED
    FDA Enforcement Class I Ongoing

    Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Ventilatory Support, Facility Use; Product Numbers DSX9999H11, INX9999H19, RINX9999H19 The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency. It is specifically for the care of adult and pediatric patients >7 years of age and >18kgs.

    Recall: Z-1972-2021 · Reported July 21, 2021

    Enforcement

    Recall Number
    Z-1972-2021
    Event ID
    88058
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips Respironics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 21, 2021
    Initiation Date
    June 14, 2021
    Classification Date
    July 13, 2021
    Address
    1001 Murry Ridge Ln, Murrysville, PA, 15668-8517, United States

    Description

    Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Ventilatory Support, Facility Use; Product Numbers DSX9999H11, INX9999H19, RINX9999H19 The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency. It is specifically for the care of adult and pediatric patients >7 years of age and >18kgs.

    Reason

    The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.

    Code Info

    All Serial Numbers Material Numbers: DSX9999H11 INX9999H19 RINX9999H19

    Distribution

    Global distribution

    Quantity

    15,357,775 (10,307,186 in US, 5,039,748 OUS) in total