BEUDAMED
    FDA Recall 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 · Initiated February 10, 2016

    Recall

    Recall Number
    Z-1098-2016
    Event Number
    73421
    Firm
    Deerfield Imaging
    FEI Number
    3010326005
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 10, 2016
    Posted
    March 11, 2016
    Terminated
    April 5, 2017
    Address
    5101 Shady Oak Rd S, Minnetonka, MN, 55343-4100

    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.

    Action

    Consignees were sent a IMRIS "Urgent Field Safety Notice" letter dated February 10, 2016. The letter described the problem and the product involved in the recall. The firm also stated that it is important that customers review the portion of the quench line vent described and ensure that it is installed to the specifications supplied as part of the Planning Guide. Customers were reminded that it is important to have an emergency plan in place in the event Helium gas escapes into the magnet room or any other area. For questions customers can contact their local customer support hotline or +1-866-475-0525.

    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