BEUDAMED
    FDA Recall Terminated

    Hitachi Oasis MRI System - C-Spine Coil

    Recall: Z-1096-2017 · Initiated January 6, 2017

    Recall

    Recall Number
    Z-1096-2017
    Event Number
    76056
    Firm
    Hitachi Medical Systems America Inc
    FEI Number
    1528028
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    January 6, 2017
    Terminated
    November 8, 2018
    Address
    1959 Summit Commerce Park, Twinsburg, OH, 44087-2371

    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.

    Action

    Hitachi sent an Urgent : Device Correction Notice dated January 3, 2017, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm plans to visit each site and replace the cable balun and also confirm receipt of the notification letter. The firm will quarantine returned baluns in their warehouse until they are reworked. For further questions regarding this recall please call (330) 425-1313 ext. 3720.

    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