BEUDAMED
    FDA Enforcement Class I Ongoing

    Philips Garbin Ventilator, Model Number 1058180B

    Recall: Z-0884-2023 · Reported January 18, 2023

    Enforcement

    Recall Number
    Z-0884-2023
    Event ID
    91293
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips Respironics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    January 18, 2023
    Initiation Date
    December 7, 2022
    Classification Date
    January 6, 2023
    Address
    1001 Murry Ridge Ln, Murrysville, PA, 15668-8517, United States

    Description

    Philips Garbin Ventilator, Model Number 1058180B

    Reason

    The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which could result in a reduction in delivered therapy volume or pressure and could cause the device to alarm.

    Code Info

    UDI: 00606959429338; Serial Numbers: GV119100314 GV118011626 GV117030343 GV117020301 GV11910210D GV117060237 GV11807062D GV119070802 GV11605061E

    Distribution

    US Nationwide and Global Distribution to countries of: Australia, Brazil, Canada, China, Germany, Japan, Korea, and Latin America.

    Quantity

    9