BEUDAMED
    FDA Enforcement Class II Terminated

    Toshiba Aquilion CT System TSX-301B

    Recall: Z-0015-2016 · Reported October 21, 2015

    Enforcement

    Recall Number
    Z-0015-2016
    Event ID
    71923
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Toshiba American Medical Systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 21, 2015
    Initiation Date
    May 8, 2015
    Classification Date
    October 9, 2015
    Termination Date
    October 26, 2016
    Address
    PO Box 2068, 2441 Michelle Dr, Tustin, CA, 92780-7047, United States

    Description

    Toshiba Aquilion CT System TSX-301B

    Reason

    If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.

    Code Info

    system software V6.0 or later

    Distribution

    US Distribution including Puerto Rico

    Quantity

    459