BEUDAMED
    FDA Recall Terminated

    Invacare IVC Home Care Bed (Foot Section with new head actuator from Linak.

    Recall: Z-0174-04 · Initiated June 9, 2003

    Recall

    Recall Number
    Z-0174-04
    Event Number
    26479
    Firm
    Invacare Corporation One Invacare Way
    FEI Number
    3002889431
    Product Code
    LLI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 9, 2003
    Posted
    July 20, 2004
    Terminated
    May 8, 2014
    Address
    Elyria, OH, 44036

    Description

    Invacare IVC Home Care Bed (Foot Section with new head actuator from Linak.

    Reason

    Pull tube on bed may bend or separate causing inoperability of bed or head section to fall.

    Action

    The firm began telephoning direct consignees on 6/9/03 and also began sending recall letters to these consignees on 6/9/03. The letter provides a list of affected units shipped to the consignee and the serial number of the affected foot section on the bed. If the consignee indicated they wanted to perform the correction themselves then the indicated number of corrective bracket installation kits are being sent. Also they are given the option of having an Invacare authorized service center perform the correction. This is for units in their possession and also at patient homes. As of October 2003 enough corrective kits have been forwarded to dealers to correct all involved units.

    Distribution

    involved products were distributed to approximately 1100 dealers in the United Stated and to 54 Canadian dealer accounts.

    Quantity

    5926