BEUDAMED
    FDA Enforcement Class II Terminated

    Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation.

    Recall: Z-2564-2014 · Reported September 10, 2014

    Enforcement

    Recall Number
    Z-2564-2014
    Event ID
    68758
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hitachi Medical Systems America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 10, 2014
    Initiation Date
    August 18, 2014
    Classification Date
    September 2, 2014
    Termination Date
    September 14, 2015
    Address
    1959 Summit Commerce Park, Twinsburg, OH, 44087-2371, United States

    Description

    Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation.

    Reason

    The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn hazard.

    Code Info

    Product Codes: Y001, Y002, Y003, Y004, Y005, Y006, Y007, Y008, Y009, Y010, Y011, Y012, Y014, Y015, Y016, Y101, Y102, Y103, Y105, and Y951. To be updated as firm submits information.

    Distribution

    Worldwide Distribution: US (nationwide) including states of: CA, DE, FL, ID, KS, KY, MD, MS, NY, OH, and WY; countries of: Japan, Brazil, France, Germany, and Kyrgyzstan.

    Quantity

    39 systems