BEUDAMED
    FDA Recall Terminated

    Invivo Corporation Expression Information Portal (Model IP5) is intended to be used as a secondary display control unit, where the device monitors the vital signs of a patient undergoing an MRI procedure from the MR control room, induction room, or recovery room and then outputs the measured patient data to a hospital information system (HIS). The Expression Information Portal (Model IP5), a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care professionals to remotely monitor the vital signs of patients undergoing MRI procedures.

    Recall: Z-0983-2014 · Initiated December 4, 2013

    Recall

    Recall Number
    Z-0983-2014
    Event Number
    67387
    Firm
    Invivo Corporation
    FEI Number
    1051786
    Product Code
    MWI
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    December 4, 2013
    Posted
    February 14, 2014
    Terminated
    September 12, 2016
    Address
    12151 Research Pkwy, Suite 200, Orlando, FL, 32826-3222

    Description

    Invivo Corporation Expression Information Portal (Model IP5) is intended to be used as a secondary display control unit, where the device monitors the vital signs of a patient undergoing an MRI procedure from the MR control room, induction room, or recovery room and then outputs the measured patient data to a hospital information system (HIS). The Expression Information Portal (Model IP5), a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care professionals to remotely monitor the vital signs of patients undergoing MRI procedures.

    Reason

    Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling the Expression Information Portal (Model IP5). Upon power up, the IP5 may fail to produce audio.

    Action

    Philips Healthcare sent an "URGENT - MEDICAL DEVICE RECALL" letter dated December 4, 2013, to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were instructed to refer to the "Action to be Taken by Customer/User section on the attached pages. A Philips representative will contact the customer regarding their affected devices. All affected devices will have a firmware update installed to correct the problem free of charge. If you need any further information or support concerning this problem, please contact your local Philips representative: 877-468-4861 option 1, then option 2. Philips apologizes for any inconveniences caused by this problem.

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of Australia, Austria, Denmark, France, Germany, Netherlands, Poland, Singapore, Sweden, Switzerland and United Kingdom.

    Quantity

    299