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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 Device Recall TomoTherapy HiArt System, Version 4.0.0 & 4.0.1.see related information
Date Initiated by FirmFebruary 22, 2010
Date PostedAugust 02, 2010
Recall Status1 Terminated 3 on February 10, 2011
Recall NumberZ-2115-2010
Recall Event ID 56052
510(K)NumberK082005 
Product Classification Radiation Therapy System - Product Code MUJ
ProductTomoTherapy 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.
FEI Number 3003873069
Recalling Firm/
Manufacturer		 TomoTherapy Incorporated
1240 Deming Way
Madison WI 53717
For Additional Information Contact
608-824-2800
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		Software design
ActionConsignees 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 Commerce7
DistributionWorldwide Distribution -- MI, MO, VA, and WI and country of CANADA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MUJ
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