BEUDAMED
    FDA Recall Terminated

    Stryker InTouch 1.0 Zoom Critical Care Bed (Model 2140) with the Integrated PositionPro mattress (Model 2920) option. The device is intended to be used as an Intensive Care Unit bed.

    Recall: Z-0943-2009 · Initiated January 5, 2009

    Recall

    Recall Number
    Z-0943-2009
    Event Number
    49610
    Firm
    Stryker Medical Div. of Stryker Corporation
    FEI Number
    1831750
    Product Code
    FNL
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 5, 2009
    Posted
    February 25, 2009
    Terminated
    November 5, 2010
    Address
    3800 E. Centre Ave., Portage, MI, 49002

    Description

    Stryker InTouch 1.0 Zoom Critical Care Bed (Model 2140) with the Integrated PositionPro mattress (Model 2920) option. The device is intended to be used as an Intensive Care Unit bed.

    Reason

    The touch screen on the footboard may display a "tilt over range" error, resulting in a precautionary stop of the bed motions which result in the bed appearing to have locked out some of its bed positioning features. Also, the "hold" button, used to interrupt an intended patient turn on beds with an integrated PositionPro mattress, may only function intermittently, resulting in an inability to ho

    Action

    Consignees were notified of the problems via letter dated January 5, 2009, advised to check their beds and to take them out of service if the foot board touchscreen displayed a "tilt over range" error, and that a Stryker Medical field service representative would contact them to perform software upgrades on the affected beds. Please direct questions to Stryker Medical at 1-269-324-6644.

    Distribution

    Worldwide Distribution including USA and countries of Canada, Japan and Switzerland.

    Quantity

    1,288 of all models