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U.S. Department of Health and Human Services

Class 2 Device Recall Radiation Therapy System

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  Class 2 Device Recall Radiation Therapy System see related information
Date Initiated by Firm September 18, 2008
Date Posted January 05, 2009
Recall Status1 Terminated 3 on April 19, 2011
Recall Number Z-0339-2009
Recall Event ID 49607
510(K)Number K060912  
Product Classification Accelerator, Linear - Product Code IYE
Product TomoTherapy HI-ART Systems with 3.1.2, 3.1.3 or 3.2.1 software. The affected applications include Planning Station, Planned Adaptive, Data Management System, and TomoPortal. The product is intended for use in radiation therapy.
Code Information USA 110001 110002 110003 110004 110005 110006 110007 110008 110012 110015 110016 110019 110020 110021 110023 110026 110027 110028 110029 110030 110031 110032 110033 110035 110038 110040 110042 110043 110044 110045 110047 110048 110050 110051 110053 110054 110056 110057 110059 110060 110067 110073 110074 110082 110084 110086 110087 110089 110090 110092 110094 110095 110096 110097 110098 110103 110105 110106 110108 110112 110115 110116 110118 110119 110120 110122 110127 110132 110134 110135 110138 110139 110149 110152 110153 110154 110155 110158 110160 110161 110165 110166 110168 110173 110174 110175 110176 110177 110179 110180 110181 110185 110186 110187 110188 110190 110192 110193 110195 110196 110197 110198 110201 110202 110203 110204 110206 110209 110210 110213 110215 110216 110217 110221 110222 110223 110224 110225 110227 110242 and 110250  OUS 110034 110062 110083 110126 110140 110014 110037 110072 110130 110169 110137 110077 110111 110117 110123 110146 110151 110189 110114 110131 110143 110170 110061 110167 110228 110157 110018 110071 110136 110162 110171 110211 110199 110150 110178 110237 110068 110078 110194 110069 110110 110191 110207 and 110240 
Recalling Firm/
Manufacturer		 TomoTherapy Incorporated
1240 Deming Way
Madison WI 53717
For Additional Information Contact
608-824-2800
Manufacturer Reason
for Recall		 TomoTherapy Inc. discovered an issue on the Hi-Art system during the course of ongoing testing. It has been identified that treatment plans involving very small structures (volume <2cc), reading in a high dose gradient region, may exhibit inaccuracies with the DVH curve and the Dose Statistics for the small structures. This error can only happen if planning was performed using very small voxels
FDA Determined
Cause 2		 Software design
Action Consignees were sent on 9/18/08 a "TomoTherapy Incorporated Urgent Medical Device Correction Field Safety Notice" letter dated September 17, 2008. The letter described the issue, product affected, recommended actions and resolution. Questions may be directed to TomoTherapy Inc. Customer Service Center at 1-868-368-4807.
Quantity in Commerce 165
Distribution AK AL AR AZ CA CO CT DC FL HI IA IL IN KY LA MA MD MI MN MO NE NJ NM NV NY OH OK OR PA PR SC SD TN TX VA WA WI and WY Belgium Canada Switzerland Germany Spain France Great Britain India Italy Japan Korea Netherlands Turkey and Taiwan
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = IYE and Original Applicant = TOMOTHERAPY INCORPORATED
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