BEUDAMED
    FDA Recall Terminated

    Invivo Corporation Expression IP5 Information Portal Product Usage: 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 professional to remotely monitor the vital signs of patients undergoing MRI procedures. Available monitoring from the IP5 can include ECG, SpO2, non-invasive and invasive blood pressure, CO2, respiration, anesthetic agents, gases, and temperature parameters.

    Recall: Z-1096-2014 · Initiated October 3, 2013

    Recall

    Recall Number
    Z-1096-2014
    Event Number
    67424
    Firm
    Invivo Corporation
    FEI Number
    1051786
    Product Code
    MWI
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 3, 2013
    Posted
    February 26, 2014
    Terminated
    September 12, 2016
    Address
    12151 Research Pkwy, Suite 200, Orlando, FL, 32826-3222

    Description

    Invivo Corporation Expression IP5 Information Portal Product Usage: 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 professional to remotely monitor the vital signs of patients undergoing MRI procedures. Available monitoring from the IP5 can include ECG, SpO2, non-invasive and invasive blood pressure, CO2, respiration, anesthetic agents, gases, and temperature parameters.

    Reason

    Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling their Expression Information Portal (Model IP5). Three different IP5 devices lost audio during use.

    Action

    Philips Healthcare sent an "URGENT - MEDICAL DEVICE RECALL" letter dated October 3, 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 software update installed in order to correct the problem free of charge. Contact your local Philips representative for further information and support.

    Distribution

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

    Quantity

    271