BEUDAMED
    FDA Recall Terminated

    Advanta 2 Bed. The Advanta 2 Bed is intended for low to moderate acuity patients in the medical/surgical area of the hospital.

    Recall: Z-1864-2012 · Initiated June 18, 2012

    Recall

    Recall Number
    Z-1864-2012
    Event Number
    62331
    Firm
    Hill-Rom, Inc.
    FEI Number
    1824206
    Product Code
    FNL
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    June 18, 2012
    Posted
    June 22, 2012
    Terminated
    June 6, 2014
    Address
    1069 State Route 46 East, Batesville, IN, 47006-7520

    Description

    Advanta 2 Bed. The Advanta 2 Bed is intended for low to moderate acuity patients in the medical/surgical area of the hospital.

    Reason

    During an evaluation of Advanta 2 siderail samples returned from the field it was found that the screws used to attach the siderail were being stripped from the plastic cavity of the siderail.

    Action

    Hill-Rom sent an "URGENT FIELD SAFETY NOTICE" dated May 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter included a Customer Response Form for customers to complete and return to the firm. Contact Hill-Rom Technical Support at 800-445-3720 for questions regarding this notice.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Canada, France, and Singapore.

    Quantity

    7843 devices