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U.S. Department of Health and Human Services

Class 2 Device Recall TomoTherapy HIART System

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 Class 2 Recall
TomoTherapy HIART System
see related information
Date Posted August 12, 2010
Recall Status1 Terminated on December 17, 2011
Recall Number Z-2219-2010
Recall Event ID 56166
Premarket Notification
510(K) Number
Product Classification System,Planning,Radiation Therapy Treatment - Product Code MUJ
Product 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
Code Information 110019
Recalling Firm/
TomoTherapy Incorporated
1240 Deming Way
Madison, Wisconsin 53717
Manufacturer Reason
for Recall
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
FDA Determined
Cause 2
DESIGN: Software Design
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.
Quantity in Commerce 1
Distribution VA
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MUJ and Original Applicant = TOMOTHERAPY INCORPORATED