BEUDAMED
    FDA Recall Terminated

    Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.

    Recall: Z-0005-2009 · Initiated September 29, 2008

    Recall

    Recall Number
    Z-0005-2009
    Event Number
    53451
    Firm
    Toshiba American Medical Systems Inc
    FEI Number
    2020563
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 29, 2008
    Posted
    September 28, 2009
    Terminated
    October 4, 2012
    Address
    2441 Michelle Dr P.O. Box 2068, Tustin, CA, 92781-2068

    Description

    Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.

    Reason

    Audible signal is not available at all times when using the HLC fluoroscopy mode. Special means of activation are not designed in for selection of High Level Controls, as required by regulation.

    Action

    Toshiba issued a letter entitled Important Electronic Product Radiation Warning, September 30, 2008, explaining the issue. The customers were requested to reply to the letter via fax-back form, and a Toshiba service representative would install the corrective action.

    Distribution

    Nationwide

    Quantity

    129