BEUDAMED
    FDA Recall Terminated

    Model FL14E Rose BedsThe Rose Bed is an AC-powered adjustable long-term care bed intended for medical purposes that consists of a bed with a built-in motor and controls that can be operated to adjust the height and surface contour of the bed. The device includes movable and latchable siderails

    Recall: Z-0363-2014 · Initiated October 23, 2013

    Recall

    Recall Number
    Z-0363-2014
    Event Number
    66137
    Firm
    Stryker Medical Division of Stryker Corporation
    FEI Number
    1831750
    Product Code
    FNL
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    October 23, 2013
    Posted
    November 19, 2013
    Terminated
    May 16, 2014
    Address
    3800 E Centre Ave, Portage, MI, 49002-5826

    Description

    Model FL14E Rose BedsThe Rose Bed is an AC-powered adjustable long-term care bed intended for medical purposes that consists of a bed with a built-in motor and controls that can be operated to adjust the height and surface contour of the bed. The device includes movable and latchable siderails

    Reason

    It was reported that the siderail may appear latched when it is not, due to lack of proper preventive maintenance. This might result in bruises and/or lacerations to a patient who is leaning against the siderails if the siderail releases. Additionally, the siderail may not effectively constrain a patient to prevent them from rolling or falling off the bed.

    Action

    Stryker Medical sent a Medical Device Notification letter dated October 23, 2013, to all affected consignees. The letter described the recalled product, potential injuries associated with the side rail sticking, as well as providing preventive measures to be taken to mitigate the risk. Consignees were directed to locate the beds listed in this notice, ensure that the siderails have been inspected and adjusted, as required, continue to routinely inspect the siderails and functionality using the enclosed, enhanced product maintenance information. Problems and concerns should be addressed to Stryker at (1-800-327-0770, option 2). Consignees were asked to Fax (269-488-8691) or e-mail ([email protected] ) the enclosed return form and directed to forward the notice if product was further distributed and advise Stryker of the beds new location. For questions regarding this recall call 269-324-6609.

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Canada; Japan, South America, Latin America and China.

    Quantity

    4126 units USA; 20449 inits Internationally