BEUDAMED
    FDA Recall Terminated

    NurseMate with Physio Module; Remote Review, Monitoring and Charting Station; USA EPMedSystems, Inc. Cooper Run Executive Park, 575 Route 73 North, Unit D, West Berlin, NJ 08090. Outer box labeled as Smiths Medical. The NurseMate Remote Review Station is an integrated review station for the EP WorkMate Computer recording system that allows a separate user to review and edit patient study date stored on the SP Work Mate System and monitor patient data from the EP WorkMate during a Patient study.

    Recall: Z-1156-2009 · Initiated February 13, 2009

    Recall

    Recall Number
    Z-1156-2009
    Event Number
    51195
    Firm
    St. Jude Medical
    FEI Number
    2126673
    Product Code
    DQK
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 13, 2009
    Posted
    April 10, 2009
    Terminated
    May 4, 2009
    Address
    575 Route 73 North, Bldg D, Cooper Run Executive Park West Berlin, NJ, 08091

    Description

    NurseMate with Physio Module; Remote Review, Monitoring and Charting Station; USA EPMedSystems, Inc. Cooper Run Executive Park, 575 Route 73 North, Unit D, West Berlin, NJ 08090. Outer box labeled as Smiths Medical. The NurseMate Remote Review Station is an integrated review station for the EP WorkMate Computer recording system that allows a separate user to review and edit patient study date stored on the SP Work Mate System and monitor patient data from the EP WorkMate during a Patient study.

    Reason

    Installation problem: there is a risk that the monitor may not be adequately secured to the stand, resulting in the monitor falling off which may cause injury.

    Action

    St. Jude Medical received a recall notice dated January 16, 2009 from its supplier, Smiths Medical PM, Inc. St. Jude Medical prepared and sent their own recall letter dated February 13, 2009 to affected customers. The recall letter described the issue and possible associated risks and provided instructions to customers. A St. Jude Medical representative will contact customers to facilitate replacement of the fasteners. Questions should be directed to your St. Jude Medical sales representative.

    Distribution

    Nationwide Distribution -- CA, NV, and FL.

    Quantity

    4 units