BEUDAMED
    FDA Enforcement Class II Terminated

    Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. Indicated for use as a magnetic resonance diagnostic device (MRDD).

    Recall: Z-1098-2016 · Reported March 23, 2016

    Enforcement

    Recall Number
    Z-1098-2016
    Event ID
    73421
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Deerfield Imaging
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 23, 2016
    Initiation Date
    February 10, 2016
    Classification Date
    March 11, 2016
    Termination Date
    April 5, 2017
    Address
    5101 Shady Oak Rd S, Minnetonka, MN, 55343-4100, United States

    Description

    Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. Indicated for use as a magnetic resonance diagnostic device (MRDD).

    Reason

    Emergency helium venting lines (i.e. quench lines) may not have been properly installed.

    Code Info

    70036, 10076-21, M00004, 10073-01, 23529, 40481, M00152, M00005, 30445, M00169, 060014, 10043-00, 30823, 10004680, 10050-01, 40662, 30935, 31084, 31203, 10002221, 40510, 40613, 30719, 31046, 30910, 30832, 30623, 31213, 10004152, 10072-01, 31250, 40815, 31049, 30068, 40412, M0038, M00106, M00367, 10035-01, 40475, 40495, 10007498, 10005946, 40263, 40688, 10058-00, 40619, 31085, and 10005639.

    Distribution

    Worldwide Distribution -- US, including the states of CA, CT, FL, GA, IL, IN, MD, MA, MN, MO, NH, NC, OH, OR, PA, TX, UT, VA, and WI; and ,countries of CHINA, CANADA, AUSTRALIA, FRANCE, JAPAN, and GERMANY.

    Quantity

    35 USA, 14 OUS