BEUDAMED
    FDA Enforcement Class II Terminated

    Philips Expression MR200 MRI Patient Monitoring System

    Recall: Z-0069-2015 · Reported October 22, 2014

    Enforcement

    Recall Number
    Z-0069-2015
    Event ID
    69179
    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
    October 22, 2014
    Initiation Date
    September 5, 2014
    Classification Date
    October 15, 2014
    Termination Date
    October 12, 2017
    Address
    12151 Research Pkwy, Suite 200, Orlando, FL, 32826-3222, United States

    Description

    Philips Expression MR200 MRI Patient Monitoring System

    Reason

    Failure to produce the Non-Invasive Blood Pressure (NIBP) Measurement.

    Code Info

    Model: 866120, Lot numbers: US33600004, US33600005, US33600006, US33600007, US33600008, US33600009, US33600010, US33600011, US33600012, US33600013, US33600014, US33600015, US33600016, US33600017, US33600018, US33600019, US33600020, US33600022, US33600023, US33600024, US33600025, US33600026, US33600027, US33600028.

    Distribution

    Worldwide Distribution - US including the states of CA, GA, MI, NJ, NV, and TX., and the countries of: Austria, Finland, Germany, Poland, Singapore, Sweden, Switzerland and United Kingdom.

    Quantity

    24 units.