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U.S. Department of Health and Human Services

Class 2 Device Recall TomoTherapy HiArt System, Version 4.0.0 & 4.0.1.

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 Class 2 Recall
TomoTherapy HiArt System, Version 4.0.0 & 4.0.1.
see related information
Date Posted August 02, 2010
Recall Status1 Terminated on February 10, 2011
Recall Number Z-2115-2010
Recall Event ID 56052
Premarket Notification
510(K) Number
K082005 
Product Classification System,Planning,Radiation Therapy Treatment - Product Code MUJ
Product 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.
Code Information Serial #'s: 110019. 110037, 110056, 110091, 110169, 110281.
Recalling Firm/
Manufacturer
TomoTherapy Incorporated
1240 Deming Way
Madison, Wisconsin 53717
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
In some cases, the patient's diagnostic CT image is narrower than the Hi-Art radiotherapy couch image.
FDA Determined
Cause 2
DESIGN: Software Design
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.
Quantity in Commerce 7
Distribution Worldwide Distribution -- MI, MO, VA, and WI and country of CANADA.
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
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