BEUDAMED
    FDA Recall Open, Classified

    Invacare Homecare Series Bed and Invacare G-Series Beds Containing Component Model Numbers: (1) G50 (2) G53 (3) G54 (4) BAR5490IVC (5) BAR5000IVC (6) 5000IVC (7) 5490IVC (8) 5490LOW

    Recall: Z-1251-2024 · Initiated January 22, 2024

    Recall

    Recall Number
    Z-1251-2024
    Event Number
    93875
    Firm
    Invacare Corporation
    FEI Number
    3002889431
    Product Code
    LLI
    Status
    Open, Classified
    Root Cause
    Process design
    Initiated
    January 22, 2024
    Posted
    March 4, 2024
    Address
    1 Invacare Way, Elyria, OH, 44035-4190

    Description

    Invacare Homecare Series Bed and Invacare G-Series Beds Containing Component Model Numbers: (1) G50 (2) G53 (3) G54 (4) BAR5490IVC (5) BAR5000IVC (6) 5000IVC (7) 5490IVC (8) 5490LOW

    Reason

    Invacare Homecare & G-Series Bed Components identified with a potential weld defect leads to premature weld failures to occur on these components

    Action

    Invacare issued Urgent Medical Device Correction letter on 12/22/23. Letter states reason for recall, health risk and action to take: 1.Please locate your affected products Please review your records to locate the affected components. Above is a list of model numbers to assist you with this process. 2. Please contact your provider at the number listed below to have the bed component replaced.

    Distribution

    US Nationwide distribution.

    Quantity

    8,117 units