BEUDAMED
    FDA Recall Terminated

    Toshiba America Medical Systems, Ultimax System MDX-8000A equipped with the EPS-Plus/ADR-1000A/E2D Digital Spot Film Device

    Recall: Z-0533-06 · Initiated February 23, 2006

    Recall

    Recall Number
    Z-0533-06
    Event Number
    34955
    Firm
    Toshiba American Med Sys Inc
    FEI Number
    2020563
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 23, 2006
    Posted
    March 29, 2006
    Terminated
    February 29, 2012
    Address
    2441 Michelle Dr, Tustin, CA, 92781

    Description

    Toshiba America Medical Systems, Ultimax System MDX-8000A equipped with the EPS-Plus/ADR-1000A/E2D Digital Spot Film Device

    Reason

    When the error condition occurs the x-ray exposures will terminate immediately. The digital system (EPS-Plus/ADR-1000A) will immediately stop acquiring images or will continue to acquire blank images. The remote console will lock-up upon release of the hand switch. The operator must reboot the system. This will result in the loss of the images acquired during the contrast portion of the study.

    Action

    Recall letter to be sent to to customers of affected devices beginning February 23, 2006. Corrected software to be issued by Toshiba America Medical Systems Inc, for all affected devices.

    Distribution

    Nationwide to AZ, CA, FL, MT, & PA

    Quantity

    5