BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1980-2025 · Initiated May 8, 2025

    Recall

    Recall Number
    Z-1980-2025
    Event Number
    96851
    Firm
    Ohio Medical Corporation
    FEI Number
    1419185
    Product Code
    CAW
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    May 8, 2025
    Posted
    June 13, 2025
    Address
    1111 Lakeside Dr, Gurnee, IL, 60031-2489

    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.

    Action

    Ohio Medical issued a Field Safety Notice to its consignees on 05/08/2025 followed by telephone calls on 05/13/2025. The notice explained the problem with the device, potential risk, and requested the devices be returned for correction. The notice further stated: "The Field Safety Notice is communicated to all impacted customers and is communicated to competent authorities in the affected markets. Receivers should pass this FSN on to all persons with a need to be advised from within your organization or to any organization where the potentially affected products have been supplied. Please consider end users and others within the supply chain in the circulation of this notice."

    Distribution

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

    Quantity

    36 units