BEUDAMED
    FDA Recall Terminated

    Toshiba Aquilion ONE CT SystemTSX-301 A/2D

    Recall: Z-2339-2010 · Initiated February 3, 2009

    Recall

    Recall Number
    Z-2339-2010
    Event Number
    52830
    Firm
    Toshiba American Medical Systems Inc
    FEI Number
    2020563
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 3, 2009
    Posted
    September 1, 2010
    Terminated
    September 2, 2011
    Address
    2441 Michelle Dr P.O. Box 2068, Tustin, CA, 92781-2068

    Description

    Toshiba Aquilion ONE CT SystemTSX-301 A/2D

    Reason

    ECG Gated Dynamic Volume Prospective scan may stop if preset eXam Plan is confirmed and CTA On is changed to CTA OFF, due to exposure control PWB.

    Action

    Toshiba America Medical System Inc (TAMS) sent an Urgent: Medical Device Correction dated January 14, 2009 to their consignees. The letter described the issue and provided instructions to test the device to determine if it is an affected device. If the device is affected, contact the Toshiba service representative at 800 521-1968. Consignees were requested to complete and fax a response form to Toshiba.

    Distribution

    Nationwide Distribution: including the states of AL, CA, FL, GA, KY, MA, MD, MT, NV, NY, OH, PA, and Puerto Rico.

    Quantity

    16