BEUDAMED
    FDA Recall Terminated

    Philips IP5 Information Portal 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-2270-2014 · Initiated June 30, 2014

    Recall

    Recall Number
    Z-2270-2014
    Event Number
    68956
    Firm
    Invivo Corporation
    FEI Number
    1051786
    Product Code
    MWI
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    June 30, 2014
    Posted
    August 19, 2014
    Terminated
    December 14, 2016
    Address
    12151 Research Pkwy, Suite 200, Orlando, FL, 32826-3222

    Description

    Philips IP5 Information Portal 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

    The wireless function of the IP5 radio could be interrupted causing loss of wireless communication between the IP5 and host monitoring system.

    Action

    The firm, Philips Healthcare, sent an "URGENT - Field Safety Notice" dated June 30, 2014 to its customers. The notice describes the product, problem and actions to be taken. The notice also provides the customers with instructions for use while waiting for the update to the IP5. A Philips representative will contact you regarding your affected device. If you need any further information or support concerning this issue, please contact your local Philips representative: 877-468-4861 option 1, then option 2.

    Distribution

    Worldwide distribution: US (nationwide) including states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, MN, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, Hawaii, Alaska, and District of Columbia; and countries of: Australia, Austria, Denmark, France, Germany, Ireland, Netherlands, Norway, Poland, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.

    Quantity

    573 devices.