BEUDAMED
    FDA Enforcement Class II Terminated

    Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F

    Recall: Z-2109-2017 · Reported June 7, 2017

    Enforcement

    Recall Number
    Z-2109-2017
    Event ID
    77195
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Toshiba American Medical Systems Inc
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    June 7, 2017
    Initiation Date
    February 1, 2017
    Classification Date
    May 30, 2017
    Termination Date
    June 6, 2018
    Address
    PO Box 2068, 2441 Michelle Dr, Tustin, CA, 92780-7047, United States

    Description

    Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F

    Reason

    It was found that during a procedure the Peak Skin Dose (PSD) value displayed by the Dose Tracking System (DTS) was larger than the DTS expected value. This issue occurs when the power for the Angio Workstation is turned on after the power for the Infinix system is turned on.

    Code Info

    S/N : 8181622393

    Distribution

    US Distribution to the states of :LA, IL, NY, FL, MA, TN, MO, GA, CA, DE, MO, AL, ID, MN, TX, CT, PA, MS, OH, NC, NV, W VA, WA, AR, NJ, MD, OK, IN and NH.

    Quantity

    US - 70 systems