BEUDAMED
    FDA Recall Terminated

    IMS Patient Scale used on Sunrise Medical's Hoyer Presence and Stature Patient Lifts (Cradle), Models: HOY-4pt-WSC and HOY-StatureWSC

    Recall: Z-0921-2007 · Initiated January 30, 2007

    Recall

    Recall Number
    Z-0921-2007
    Event Number
    37774
    Firm
    Integrated Measurement Systems, Inc.
    FEI Number
    3002780774
    Product Code
    FRW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 30, 2007
    Posted
    June 19, 2007
    Terminated
    March 2, 2008
    Address
    440 Bonnie Ln, Elk Grove Village, IL, 60007-1908

    Description

    IMS Patient Scale used on Sunrise Medical's Hoyer Presence and Stature Patient Lifts (Cradle), Models: HOY-4pt-WSC and HOY-StatureWSC

    Reason

    Patient Scale may become detached, which can cause a patient to fall and result in injury.

    Action

    The scale manufacturer, IMS, in conjunction with the lift manufacturer, Joerns Healthcare (previously Sunrise Medical), will initiate a field fix strategy consisting of shipping replacement 4-point cradles without scales, for use until a replacement can be designed, tested and validated. Joerns will utilize their Customer Service Help Line (1-800-826-0270) on behalf of IMS, to inform customers of the voluntary field correction, address any questions regarding the IMS scale field fix strategy and to provide additional information on return of affected IMS Patient Scales. Customers were notified by telephone beginning on January 30, 2007.

    Distribution

    Worldwide

    Quantity

    149 units