BEUDAMED
    FDA Enforcement Class II Terminated

    Philips Expression MR200 MRI Patient Monitoring System.

    Recall: Z-0958-2015 · Reported January 21, 2015

    Enforcement

    Recall Number
    Z-0958-2015
    Event ID
    69587
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Invivo Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    January 21, 2015
    Initiation Date
    October 22, 2014
    Classification Date
    January 13, 2015
    Termination Date
    January 9, 2017
    Address
    12151 Research Pkwy, Suite 200, Orlando, FL, 32826-3222, United States

    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.

    Code Info

    Model No. 866120; Lot/ Serial Numbers: US33600065, US33600066, US33600075, US33600077, US33600078, US33600079; US33600080, US33600081, US33600082, US33600083, US33600084, US33600086, US33600087, US33600088, US33600089, US33600090, US33600091, US33600092, US33600093, US33600094.

    Distribution

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

    Quantity

    20