BEUDAMED
    FDA Enforcement Class II Ongoing

    GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S

    Recall: Z-1980-2025 · Reported June 25, 2025

    Enforcement

    Recall Number
    Z-1980-2025
    Event ID
    96851
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ohio Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 25, 2025
    Initiation Date
    May 8, 2025
    Classification Date
    June 13, 2025
    Address
    1111 Lakeside Dr, N/A, Gurnee, IL, 60031-2489, United States

    Description

    GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S

    Reason

    Erroneous calibration values, potentially resulting in: as the device ages, oxygen purity will gradually decrease to the point where the device alarms to indicate low oxygen purity will be incorrect.

    Code Info

    Serial Numbers: ZL316367, ZL316446, ZL316462, ZL316475, ZL316481, ZL316484, ZL316490, ZL316493, ZL316503, ZL317057, ZL317087, ZL317088, ZL317090, ZL322386, ZL322387, ZL322390, ZL322392, ZL322409, ZL322412, ZL322439, ZL322441, ZL322442, ZL322443, ZL322445, ZL322447, ZL322451, ZL322455, ZL322456, ZL322462, ZL322463, ZL322466, ZL322467, ZL322470, ZL322472, ZL322473, ZL322837.

    Distribution

    US Nationwide distribution in the states of AR, FL, VA, ND, MS, MN, CA, NV, KY.

    Quantity

    36 units