BEUDAMED
    FDA Enforcement Class II Terminated

    Toshiba America Medical Systems, Inc . Aquilion RXL TSX-101 A/R, U CT Scanner Diagnostic imaging systems indicated to acquire and display cross sectional volumes of the whole body, to include the head.

    Recall: Z-0047-2017 · Reported October 12, 2016

    Enforcement

    Recall Number
    Z-0047-2017
    Event ID
    74871
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Toshiba American Medical Systems Inc
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    October 12, 2016
    Initiation Date
    April 25, 2016
    Classification Date
    October 6, 2016
    Termination Date
    July 13, 2017
    Address
    PO Box 2068, 2441 Michelle Dr, Tustin, CA, 92780-7047, United States

    Description

    Toshiba America Medical Systems, Inc . Aquilion RXL TSX-101 A/R, U CT Scanner Diagnostic imaging systems indicated to acquire and display cross sectional volumes of the whole body, to include the head.

    Reason

    It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. As a result, scanning may be interrupted and rebooting of the system may be necessary. Please note that this issue has not occurred in the U.S.

    Code Info

    LL 500

    Distribution

    US Distribution to the states of: PA, IA, MA, SD, MI, LA, KY, NC, NY, AR, IN, WI, OH, TY, FL, WV, WA, CT, MS, AL, ND, CO, HI, NO, MN, ID, OH, GA, MT, LA, NM, VT, TN, CA, NH, NJ, NE, SC and KS.

    Quantity

    165