BEUDAMED
    FDA Recall Terminated

    TomoTherapy HI-ART Systems with 3.1.2, 3.1.3 or 3.2.1 software. The affected applications include Planning Station, Planned Adaptive, Data Management System, and TomoPortal. The product is intended for use in radiation therapy.

    Recall: Z-0339-2009 · Initiated September 18, 2008

    Recall

    Recall Number
    Z-0339-2009
    Event Number
    49607
    Firm
    TomoTherapy Incorporated
    FEI Number
    3003873069
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 18, 2008
    Posted
    January 5, 2009
    Terminated
    April 19, 2011
    Address
    1240 Deming Way, Madison, WI, 53717

    Description

    TomoTherapy HI-ART Systems with 3.1.2, 3.1.3 or 3.2.1 software. The affected applications include Planning Station, Planned Adaptive, Data Management System, and TomoPortal. The product is intended for use in radiation therapy.

    Reason

    TomoTherapy Inc. discovered an issue on the Hi-Art system during the course of ongoing testing. It has been identified that treatment plans involving very small structures (volume <2cc), reading in a high dose gradient region, may exhibit inaccuracies with the DVH curve and the Dose Statistics for the small structures. This error can only happen if planning was performed using very small voxels

    Action

    Consignees were sent on 9/18/08 a "TomoTherapy Incorporated Urgent Medical Device Correction Field Safety Notice" letter dated September 17, 2008. The letter described the issue, product affected, recommended actions and resolution. Questions may be directed to TomoTherapy Inc. Customer Service Center at 1-868-368-4807.

    Distribution

    AK AL AR AZ CA CO CT DC FL HI IA IL IN KY LA MA MD MI MN MO NE NJ NM NV NY OH OK OR PA PR SC SD TN TX VA WA WI and WY Belgium Canada Switzerland Germany Spain France Great Britain India Italy Japan Korea Netherlands Turkey and Taiwan

    Quantity

    165