BEUDAMED
    FDA Enforcement Class II Terminated

    IMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative MRI systems are traditional MRI systems that have been suspended on an overhead rail system. and is designated to operative inside an RF shielded room to facilitate intraoperative and multi room use.

    Recall: Z-1645-2018 · Reported May 16, 2018

    Enforcement

    Recall Number
    Z-1645-2018
    Event ID
    79816
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Deerfield Imaging, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 16, 2018
    Initiation Date
    April 4, 2018
    Classification Date
    May 4, 2018
    Termination Date
    July 22, 2020
    Address
    5101 Shady Oak Rd S, N/A, Minnetonka, MN, 55343-4100, United States

    Description

    IMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative MRI systems are traditional MRI systems that have been suspended on an overhead rail system. and is designated to operative inside an RF shielded room to facilitate intraoperative and multi room use.

    Reason

    The DC power to the IFOSS collision detector control panel at your facility is being adversely affected by the magnetic field. Our investigation shows the magnetic field is causing the IFOSS control panel to malfunction.

    Code Info

    Serial Numbers: 10111-00, 10073-01, 10043-01, 10097-01, 10006-11, 10076-21, 10081-01, 10089-01, 10101-01, 10093-01

    Distribution

    Worldwide Distribution - US Nationwide in the states of OH, FL, NH, TX, Sweden, Canada

    Quantity

    10 units