BEUDAMED
    FDA Enforcement Class II Terminated

    Hitachi Oasis MRI System - C-Spine Coil

    Recall: Z-1096-2017 · Reported February 1, 2017

    Enforcement

    Recall Number
    Z-1096-2017
    Event ID
    76056
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hitachi Medical Systems America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 1, 2017
    Initiation Date
    January 6, 2017
    Classification Date
    January 26, 2017
    Termination Date
    November 8, 2018
    Address
    1959 Summit Commerce Park, N/A, Twinsburg, OH, 44087-2371, United States

    Description

    Hitachi Oasis MRI System - C-Spine Coil

    Reason

    The customer indicated that the coil balun was hot to the touch when removing the coil from the patient table after an exam.

    Code Info

    M001 to M028, M029 to M083, M085 to M090, M092 to M104, M106, M110 to M111, M113 to M114, M116 to M123, M125, M128 to M131, M133, M139 to M141, M143 to M147, M150, M152, M154, M159, M161, M163, M166, M169 to M176, M179, M182, M183, M185, M186, M190, M194 to 196, M201, M207 to M238

    Distribution

    USA (nationwide) distribution. The product was distributed to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NM, NY, OH, OK, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY. There are three (3) government accounts for this recall: VA Medical Center/Lyster Army Health Clinic, Parma VA Medical Center, Outpatient Clinic. There are no Canada accounts for this recall. There are no Mexico accounts for this recall.

    Quantity

    180 units