BEUDAMED
    FDA Enforcement Class II Ongoing

    DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR

    Recall: Z-1558-2023 · Reported May 10, 2023

    Enforcement

    Recall Number
    Z-1558-2023
    Event ID
    91804
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DeVilbiss Healthcare LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    May 10, 2023
    Initiation Date
    March 9, 2023
    Classification Date
    May 4, 2023
    Address
    100 Devilbiss Dr, Somerset, PA, 15501-2125, United States

    Description

    DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR

    Reason

    The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard.

    Code Info

    Model 1025DS - UDI-DI: 00885304000846; Serial Numbers A175230001DS to A232160185DS; Model 1025UK - UDI-DI: 00885304022480; Serial Numbers A179210001US to A232060432US; Model 1025KS - UDI-DI: 00853040224734; Serial Numbers A176060001KS to A232220085KS; Model 1025KS-AR - UDI-DI: 00853040224734; Serial Numbers A216240003KS to A229210010KR

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    143,397 units