BEUDAMED
    FDA Recall Terminated

    Toshiba America Medical Systems Inc (TAMS) Digital Radiography System Radrex-i DRAD-3000E; Electrostatic x-ray imaging system

    Recall: Z-1177-2010 · Initiated May 22, 2009

    Recall

    Recall Number
    Z-1177-2010
    Event Number
    52816
    Firm
    Toshiba American Medical Systems Inc
    FEI Number
    2020563
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    May 22, 2009
    Posted
    March 22, 2010
    Terminated
    March 21, 2012
    Address
    2441 Michelle Dr P.O. Box 2068, Tustin, CA, 92781-2068

    Description

    Toshiba America Medical Systems Inc (TAMS) Digital Radiography System Radrex-i DRAD-3000E; Electrostatic x-ray imaging system

    Reason

    Toshiba America Medical Systems Inc (TAMS) has initiated a field correction on the DRAD-3000E; Radrex-I, Electrostatic x-ray imaging system due to a software bug that results in a loss of image.

    Action

    An Urgent - Medical Device Correction letter was sent to customers. The letter described the issue, the corrective action, and the avoidance. Toshiba America Medical Systems informed customers that software was being prepared to address the issue and planned to send representatives to each customer affected by the field correction to provide a software upgrade to the DRAD-3000E; Radrex-I, Electrostatic x-ray imaging system. Customers were to complete the attached customer reply form. Questions were to be directed to Aaron Ybarra, X-ray Product Manager at 800-421-1968, ext. 2492.

    Distribution

    Nationwide Distribution -- Including states of PA, VA, OH, TN, LA, IL, CA, MT, AZ, and TX.

    Quantity

    20