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U.S. Department of Health and Human Services

Class 2 Device Recall HIART SYSTEM

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 Class 2 Recall
HIART SYSTEM
see related information
Date Posted September 21, 2009
Recall Status1 Open
Recall Number Z-2243-2009
Recall Event ID 52729
Premarket Notification
510(K) Number
K060912 
Product Classification System,Planning,Radiation Therapy Treatment - Product Code MUJ
Product TomoTherapy Hi-Art System®, Version 3.X ThomoTherapy Incorporated 1240 Deming Way, Madison, WI 53717. The TomoTherapy HI-ART System®® is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy (IMRT). The HI-ART System provides precise delivery of radiation to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.
Code Information Serial Numbers: 110001 110040 110078 110118 110159 110197 110238 110002 110041 110079 110119 110160 110198 110239 110003 110042 110081 110120 110161 110199 110240 110004 110043 110082 110122 110162 110200 110241 110005 110044 110083 110123 110164 110201 110242 110006 110045 110084 110125 110165 110202 110243 110007 110046 110085 110126 110166 110203 110244 110008 110047 110086 110127 110167 110204 110245 110009 110048 110087 110128 110168 110205 110246 110012 110049 110088 110129 110169 110206 110247 110013 110050 110089 110130 110170 110207 110248 110014 110051 110090 110131 110171 110208 110249 110015 110052 110091 110132 110172 110209 110250 110016 110053 110092 110133 110173 110210 110251 110017 110054 110093 110134 110174 110211 110252 110018 110055 110094 110135 110175 110212 110253 110019 110056 110095 110136 110176 110213 110254 110020 110057 110096 110137 110177 110214 110255 110021 110058 110097 110138 110178 110215 110256 110022 110059 110098 110139 110179 110216 110257 110023 110060 110100 110140 110180 110217 110258 110024 110061 110101 110141 110181 110218 110259 110025 110062 110103 110142 110182 110219 110260 110026 110063 110104 110143 110183 110220 110262 110027 110064 110105 110144 110184 110221 110263 110028 110065 110106 110145 110185 110222 110264 110029 110066 110107 110146 110186 110223 110265 110030 110067 110108 110149 110187 110224 110266 110031 110068 110109 110150 110188 110225 110267 110032 110069 110110 110151 110189 110227 110268 110033 110071 110111 110152 110190 110228 110269 110034 110072 110112 110153 110191 110230 110272 110035 110073 110113 110154 110192 110233 110275 110036 110074 110114 110155 110193 110234 110276 110037 110075 110115 110156 110194 110235 110277 110038 110076 110116 110157 110195 110236 110280 110039 110077 110117 110158 110196 110237 and 110283.
Recalling Firm/
Manufacturer
TomoTherapy Incorporated
1240 Deming Way
Madison, Wisconsin 53717
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
TomoTherapy received one customer report indicating that after starting a patient procedure from the Status Console, the radiation on light and the audible indicator on the Status Console came on as expected, however the Operator Station (OS) did not display the dose rate and the procedure time, or the couch position updates. Within a few minutes, the customer pressed the Stop button on the Sta
FDA Determined
Cause 2
DESIGN: Software Design
Action Consignees were sent a TomoTherapy "Urgent Medical Device Correction Field Safety Notice" letter dated August 10, 2009. The letter addressed the Issue, Product Affected, Investigation, Recommended Actions and Resolution. Customers were recommended to perform the following actions (in the event that the dose rate, procedure timer, and couch position updates are not present on the OS, after pressing Start on the status console and the radiation on light and audible indicators are active): 1) Immediately press the Stop button on the Status Console and 2) contact your authorized TomoTherapy Service Representative for further direction. The affected issue will be corrected in the next software version, which is scheduled for release in early 2010. The TomoTherapy Customer Contact Center can be reached 24 hours a day, 7 days a week, by e-mail at support@tomotherapy.com or by phone at 1-866-368-4807 (North America).
Quantity in Commerce 259 (169 US; 91 OUS)
Distribution Worldwide Distribution -- US (states of AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, HI, IL IN, IA, KS, KY, LA, MD, MA, MI, MN,MO, NE,NV,NJ, NM, NY, OH, OK OR, PA, PR, SC, SC, TN, TX, UT, VA, WA, WI and WY) and Belgium Canada Switzerland China Germany Spain France England Hong Kong India Italy Japan Korea Netherlands Poland Saudi Arabia Sweden Singapore Turkey and Taiwan.
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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