BEUDAMED
    FDA Enforcement Class II Terminated

    Hitachi Scenaria Whole-body X-ray CT System

    Recall: Z-0271-2020 · Reported November 13, 2019

    Enforcement

    Recall Number
    Z-0271-2020
    Event ID
    84133
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hitachi Medical Systems America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 13, 2019
    Initiation Date
    October 16, 2019
    Classification Date
    November 1, 2019
    Termination Date
    April 30, 2020
    Address
    1959 Summit Commerce Park, N/A, Twinsburg, OH, 44087-2371, United States

    Description

    Hitachi Scenaria Whole-body X-ray CT System

    Reason

    There is a possibility that the cables to the controller unit may not be affixed properly, creating the potential for a cable to detach during scanning and eject from the system.

    Code Info

    Scenaria units S5002-S5014, S5017-S5044

    Distribution

    The devices were distributed to the following US states: CA, FL, GA, IA, IN, MD, MT, NC, NY, OH, OK, SD, TN, TX, WY, and PR. The products were distributed to the following foreign countries: Brazil and Mexico.

    Quantity

    39