BEUDAMED
    FDA Recall Terminated

    Hitachi Echelon Magnetic Resonance Imaging System, Serial Number: V-001, equipped with CTL coil type: MR-CTL-150.

    Recall: Z-0152-2007 · Initiated August 14, 2006

    Recall

    Recall Number
    Z-0152-2007
    Event Number
    36525
    Firm
    Hitachi Medical Systems America Inc
    FEI Number
    1528028
    Product Code
    MOS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 14, 2006
    Posted
    November 4, 2006
    Terminated
    September 19, 2012
    Address
    1959 Summit Commerce Park, Twinsburg, OH, 44087-2371

    Description

    Hitachi Echelon Magnetic Resonance Imaging System, Serial Number: V-001, equipped with CTL coil type: MR-CTL-150.

    Reason

    Component defect/overheating device; A malfunctioning decoupling circuit in the CTL coil caused high current flow and circuit overheating.

    Action

    The recalling firm issued a Device Correction letter to the clinic customer on 9/15/2006 making them aware of this potential problem and of their completed corrective action on 8/14/2006, by a Service Rep visit.

    Distribution

    The recalled unit was distributed to a single customer.

    Quantity

    1 unit