BEUDAMED
    FDA Recall Terminated

    Stryker Epic II critical care bed, 230v, Stryker Medical, Portage, MI; Model 2031. (Note: This product is not sold in the US). Beds are A/C powered hospital beds that are intended for medical purposes within the hospital setting.

    Recall: Z-2214-2009 · Initiated August 10, 2009

    Recall

    Recall Number
    Z-2214-2009
    Event Number
    52230
    Firm
    Stryker Medical Div. of Stryker Corporation
    FEI Number
    1831750
    Product Code
    FNL
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 10, 2009
    Posted
    September 18, 2009
    Terminated
    April 25, 2011
    Address
    3800 E. Centre Ave., Portage, MI, 49002

    Description

    Stryker Epic II critical care bed, 230v, Stryker Medical, Portage, MI; Model 2031. (Note: This product is not sold in the US). Beds are A/C powered hospital beds that are intended for medical purposes within the hospital setting.

    Reason

    The backrest of the bed may not stay in an upright position (may drift down when left raised).

    Action

    Stryker Medical issued an "Urgent - Medical Device Correction" letter dated August 10, 2009 informing customers to locate the affected product listed and verify whether it is functioning properly. In the case the device is not properly functioning, remove from service and contact the firm as soon as possible at 1-800-STRYKER, option 3. Customers are also asked to return an enclosed return receipt post card and also forward the notification to users who have loaned or purchased the device. A representative from Stryker field service will be contacting you to perform device corrections shortly. For further information, contact Stryker Medical at 1-269-324-6527.

    Distribution

    Worldwide Distribution -- United States, Brazil, Canada, Chile, China, India, Korea, Latin America, Mexico, Singapore and Switzerland.

    Quantity

    12,599 of all products