BEUDAMED
    FDA Recall Terminated

    Hitachi AIRIS II MRI System

    Recall: Z-1115-06 · Initiated April 25, 2006

    Recall

    Recall Number
    Z-1115-06
    Event Number
    35107
    Firm
    Hitachi Medical Systems America Inc
    FEI Number
    1528028
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 25, 2006
    Posted
    June 14, 2006
    Terminated
    October 29, 2008
    Address
    1959 Summit Commerce Park, Twinsburg, OH, 44087-2371

    Description

    Hitachi AIRIS II MRI System

    Reason

    Improper Assembly-The AIRIS/AIRIS II MRI system has the potential for the input wiring of a power transformer to overheat due to damaged wiring or possible loose connections.

    Action

    The recalling firm plans to inspect the transformer connections for damaged wiring and check the connections for tightness and tighten as necessary. The inspections and possible corrections began on 4/25/2006 and are in the process of being conducted by the firm''s Field Service Engineers. The firm anticipates trhat these actions will be completed by 6/25/2006.

    Distribution

    The devices were distributed to consignees located throughout the United States.

    Quantity

    248