BEUDAMED
    FDA Recall Terminated

    Philips Expression MR200 MRI Patient Monitoring System.

    Recall: Z-0958-2015 · Initiated October 22, 2014

    Recall

    Recall Number
    Z-0958-2015
    Event Number
    69587
    Firm
    Invivo Corporation
    FEI Number
    1051786
    Product Code
    MWI
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    October 22, 2014
    Posted
    January 13, 2015
    Terminated
    January 9, 2017
    Address
    12151 Research Pkwy, Suite 200, Orlando, FL, 32826-3222

    Description

    Philips Expression MR200 MRI Patient Monitoring System.

    Reason

    The MR 200 devices failed the initial power up test due to capacitor short and hi-pot testing; possible loss of Patient Monitoring or User/Service Electrical Shock.

    Action

    Philips Medical Systems sent an Urgent - Medical Device Correction Letter dated October 22, 2014, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. Our records indicate that you have an affected device. The following page provides additional instructions and actions that will be taken to address this problem. 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

    CA, FL, IN, KY, MN, NC, NJ, NY, OK, SD and TX Netherlands, Poland and United Kingdom.

    Quantity

    20