BEUDAMED
    FDA Enforcement Class II Terminated

    Philips Expression MR200 MRI Patient Monitoring System Model 866120

    Recall: Z-0001-2015 · Reported October 8, 2014

    Enforcement

    Recall Number
    Z-0001-2015
    Event ID
    69192
    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 8, 2014
    Initiation Date
    September 8, 2014
    Classification Date
    October 1, 2014
    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 Model 866120

    Reason

    During production, excess metal (aluminum) debris was found stuck to the cling plastic that covers the device's pole assembly. The metallic debris could affect system performance due to the potential for a failure to power up or loss of power. This could result in the loss of monitoring and a delay in diagnosis of the patient.

    Code Info

    Model 866120 with the following lots #'s: US33600006, US33600007, US33600011, US33600012 and US33600013

    Distribution

    Worldwide Distribution: US distribution in state of: CA and countries of: Poland, Singapore, and Sweden.

    Quantity

    10 units