BEUDAMED
    FDA Recall 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 · Initiated March 23, 2017

    Recall

    Recall Number
    Z-3111-2017
    Event Number
    77888
    Firm
    Toshiba American Medical Systems
    FEI Number
    2020563
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 23, 2017
    Terminated
    October 23, 2020
    Address
    2441 Michelle Dr, Tustin, CA, 92780-7047

    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.

    Action

    Toshiba America Medical Systems Inc. planned action to bring defect into compliance: 1.You will issue a Customer Notification Letter to make customers aware of the hazards, what measures will be taken to remedy the defect at no cost to the user, and how to safely use the equipment before corrections can be made. 2.You will install modified firmware on the systems to correct the defect and prevent recurrence. 3.You will provide progress reports on the effectiveness of the plan. If you have any questions, please feel free to contact your local Toshiba representative at (800) 421-1968.

    Distribution

    USA (nationwide) Distribution

    Quantity

    140