BEUDAMED
    FDA Recall Terminated

    Hi-Art System, H-0000-0003 Usage: The TomoTherapy Hi-Art System is intended to be used as an integrated system for the 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. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan

    Recall: Z-2219-2010 · Initiated December 1, 2009

    Recall

    Recall Number
    Z-2219-2010
    Event Number
    56166
    Firm
    TomoTherapy Incorporated
    FEI Number
    3003873069
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 1, 2009
    Posted
    August 12, 2010
    Terminated
    December 17, 2011
    Address
    1240 Deming Way, Madison, WI, 53717

    Description

    Hi-Art System, H-0000-0003 Usage: The TomoTherapy Hi-Art System is intended to be used as an integrated system for the 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. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan

    Reason

    An issue was identified with the TomoTherapy HI-Art System. In the event a patient or DQA plan has a moved image, roll adjustments applied during registration will be incorrect. The Planning Station Plan Settings and DQA Setup tabs allow for images to be moved during planning. During registration when roll is applied on moved images, the Operator Station incorrectly rolls the image about

    Action

    Consignee was sent a TomoTherapy "Urgent Medical device Correction Field Safety Notice' dated December 01, 2009. The letter described the Issue, Product Affected, Recommended Action and Resolution.

    Distribution

    VA

    Quantity

    1