BEUDAMED
    FDA Recall Terminated

    Altaire, Magnetic Resonance Imaging Device.

    Recall: Z-0846-05 · Initiated November 18, 2004

    Recall

    Recall Number
    Z-0846-05
    Event Number
    31772
    Firm
    Hitachi Medical Systems America Inc
    FEI Number
    1528028
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 18, 2004
    Posted
    May 17, 2005
    Terminated
    January 4, 2008
    Address
    1995 Summit Commerce Park, Twinsburg, OH, 44087-2371

    Description

    Altaire, Magnetic Resonance Imaging Device.

    Reason

    The absorber unit in the helium compressor which is located in equipment rooms, and is not accessed by patients or system operators, may fail under pressure, causing an explosion that damages the compressor.

    Action

    The firm implemented site inspections of customers beginning on 11/19/04 which have been completed. Customers that had the suspect component had it replaced.

    Distribution

    Direct accounts located in AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI.

    Quantity

    189 devices