BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1558-2023 · Initiated March 9, 2023

    Recall

    Recall Number
    Z-1558-2023
    Event Number
    91804
    Firm
    DeVilbiss Healthcare LLC
    FEI Number
    2515872
    Product Code
    CAW
    Status
    Open, Classified
    Root Cause
    Labeling design
    Initiated
    March 9, 2023
    Posted
    May 4, 2023
    Address
    100 Devilbiss Dr, Somerset, PA, 15501-2125

    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.

    Action

    An URGENT NOTICE MEDICAL DEVICE CORRECTION notification dated 3/9/23 was sent to customers. Actions to be Taken by Our Customers Please immediately click on the hyperlinked Verification Code at the top of this Notice to go to our dedicated instruction manual update website, www.recallrtr.com/1025series (or access the website manually), and follow the simple process set up to: Download electronic copies, or order hard copies, of the updated instruction manual. Download a spreadsheet containing the serial numbers of all affected units sold to your company. Replace the instruction manual for any units in your possession, and distribute the updated instruction manual to your customers, and Submit an Acknowledgement Form confirming the number of instruction manuals you replaced and distributed to customers to replace. Should you need further assistance, we have also set up a dedicated call center, which can be reached at 1 (833) 820-0836, from 8:00 am to 7:00 pm EST Monday through Friday.

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    143,397 units