BEUDAMED
    FDA Recall Terminated

    Hitachi AIRIS, AIRIS II, AIRIS Elite MRI Scanner Compensation Coil. Part numbers: MR-FC-2EO, MR-FC-3EO

    Recall: Z-1616-2010 · Initiated April 19, 2010

    Recall

    Recall Number
    Z-1616-2010
    Event Number
    55555
    Firm
    Hitachi Medical Systems America Inc
    FEI Number
    1528028
    Product Code
    MOS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 19, 2010
    Posted
    May 19, 2010
    Terminated
    September 21, 2012
    Address
    1959 Summit Commerce Park, Twinsburg, OH, 44087

    Description

    Hitachi AIRIS, AIRIS II, AIRIS Elite MRI Scanner Compensation Coil. Part numbers: MR-FC-2EO, MR-FC-3EO

    Reason

    Hitachi determined that the mounting method for a Compensation Coil did not include an appropriate factor of safety, so it is possible that the coil could fall, contacting the patient table and potentially putting a patient at risk.

    Action

    On 4/15/2010 the firm sent Device Correction Notice letters to their customers identifying the affected product and informing them of the potential problem. The letter stated that the firm will change the coil mounting method used at the customer's facility, if necessary, at no cost to the customer. A service rep will contact them to schedule a visit to correct the problem.

    Distribution

    Nationwide Distribution -- AL, AR, AZ, CA, CT, DC, DE, FL, ID, IL, IN, KY, LA, MD, MO, NJ, NY, OH, OK, OR, RI, TN, TX, VA & WA.

    Quantity

    56 devices