BEUDAMED
    FDA Recall Terminated

    Toshiba DRAD-3000E FPD Wireless System Product Usage The DRAD-3000 is intended for use 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 transmission/output or images to external devices.

    Recall: Z-1175-2016 · Initiated January 14, 2016

    Recall

    Recall Number
    Z-1175-2016
    Event Number
    73064
    Firm
    Toshiba American Medical Systems Inc
    FEI Number
    2020563
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    January 14, 2016
    Posted
    March 21, 2016
    Terminated
    February 24, 2017
    Address
    2441 Michelle Dr PO Box 2068, Tustin, CA, 92780-7047

    Description

    Toshiba DRAD-3000E FPD Wireless System Product Usage The DRAD-3000 is intended for use 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 transmission/output or images to external devices.

    Reason

    When a user performed radiography using the wireless FPD, a message window appeared on the monitor stating that imaging transmission was not completed with no radiographic image. It also indicated to select the "OK" button to re-acquire the image data or to select the'Cancel" button to cancel the re-acquisition. As instructed the user selected "OK" and the same message window appeared. This same operation was repeated several times with the identical result - no image. Finally, the user selected "Cancel" and the re-acquisition was terminated.

    Action

    Toshiba's planned action: 1."Toshiba America Medical Systems, Inc. (TAMS) will advise contact customers to stop using the system if any abnormalities are found using the system. 2. TAMS will install the software and perform testing to ensure the software update was effective. 3. The customer notification letter which includes a statement that TAMS will without charge, remedy the defect or bring the product into compliance. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. TAMS will implement this CAP by June 30, 2016. Customers with questions were advised to call 301-796-5910. For questions regarding this recall call 714-730-5000.

    Distribution

    Nationwide distribution to PA, UT, FL, NY, LA, WV, NJ, OH, WI and TX.

    Quantity

    28