BEUDAMED
    FDA Recall Terminated

    TomoTherapy Hi-Art System, Version 4.0.0 & 4.0.1. TomoTherapy Incorporated 1240 Deming Way, Madison, WI 53717. Intended to be used as an integrated system for planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.

    Recall: Z-2115-2010 · Initiated February 22, 2010

    Recall

    Recall Number
    Z-2115-2010
    Event Number
    56052
    Firm
    TomoTherapy Incorporated
    FEI Number
    3003873069
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 22, 2010
    Posted
    August 2, 2010
    Terminated
    February 10, 2011
    Address
    1240 Deming Way, Madison, WI, 53717

    Description

    TomoTherapy Hi-Art System, Version 4.0.0 & 4.0.1. TomoTherapy Incorporated 1240 Deming Way, Madison, WI 53717. Intended to be used as an integrated system for planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.

    Reason

    In some cases, the patient's diagnostic CT image is narrower than the Hi-Art radiotherapy couch image.

    Action

    Consignees were sent on 2/22/10 a TomoTherapy Incorporated "Urgent Medical Device Correction Field Safety Notice" letter dated Monday, February 22, 2010. The letter was addressed to TomoTherapy Customer and identified the the affected product, and included a description of the Issue, Product Affected, Recommendation Actions and Resolution. The issue will be remedied by software versions 4.0.2 and later. Questions should be directed towards TomoTherapy Customer Interaction Center by e-mail or telephone.

    Distribution

    Worldwide Distribution -- MI, MO, VA, and WI and country of CANADA.

    Quantity

    7