BEUDAMED
    FDA Enforcement Class II Terminated

    Toshiba Medical Radrex - i Digital Radiography X-ray system Radrex-i is intended for use in conjunction with the ceiling suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the head, chest, abdomen, spine, neck, and limbs. This system is used for image acquisition, image display and trans mission/ output of images to external devices.

    Recall: Z-3111-2017 · Reported September 20, 2017

    Enforcement

    Recall Number
    Z-3111-2017
    Event ID
    77888
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Toshiba American Medical Systems
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    September 20, 2017
    Initiation Date
    March 23, 2017
    Classification Date
    September 11, 2017
    Termination Date
    October 23, 2020
    Address
    2441 Michelle Dr, N/A, Tustin, CA, 92780-7047, United States

    Description

    Toshiba Medical Radrex - i Digital Radiography X-ray system Radrex-i is intended for use in conjunction with the ceiling suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the head, chest, abdomen, spine, neck, and limbs. This system is used for image acquisition, image display and trans mission/ output of images to external devices.

    Reason

    It was discovered during a procedure that when the operator made an exposure on the wireless x-ray detector and the image data was sent to the digital radiography system, and error message was displayed " System Error (2063)" which required a reboot and loss of the image.

    Code Info

    Serial No. W8B1572022

    Distribution

    USA (nationwide) Distribution

    Quantity

    140