BEUDAMED
    FDA Enforcement Class II Ongoing

    125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB

    Recall: Z-0229-2023 · Reported November 23, 2022

    Enforcement

    Recall Number
    Z-0229-2023
    Event ID
    90950
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DeVilbiss Healthcare LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    November 23, 2022
    Initiation Date
    September 19, 2022
    Classification Date
    November 11, 2022
    Address
    100 Devilbiss Dr, N/A, Somerset, PA, 15501-2125, United States

    Description

    125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB

    Reason

    An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway)

    Code Info

    UDI: 00885304022237 S/N: New Sales D22829087DS D22829097DS D22829092DS D22829086DS D22829156DS D22901205DS D22901207DS D22829099DS D22829161DS D22901203DS D22829157DS D22829159DS D22901204DS D22901201DS D22829096DS D22826095DS D22826079DS D22826091DS D22826086DS S/N: Repair D22829087DS D22829097DS D22829092DS D22829086DS D22829156DS D22901205DS D22901207DS D22829099DS D22829161DS D22901203DS D22829157DS D22829159DS D22901204DS D22901201DS D22829096DS D22826095DS D22826079DS D22826091DS D22826086DS

    Distribution

    US Distribution in states of: CA, FL, OH, MI, MN, NY, PA, and TX; and (Foreign) country of: Canada.

    Quantity

    48 units