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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 March 14, 2011
Recall Status1 Terminated on March 18, 2014
Recall Number Z-1649-2011
Recall Event ID 57914
Premarket Notification
510(K) Number
K082005 
Product Classification System,Planning,Radiation Therapy Treatment - Product Code MUJ
Product TomoTherapy Hi-ART System, Model # H-0000-0003 Intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or sterotactic radiosurgery to tumors or the targeted tissues.
Code Information Serial no. 110319 110126 110055 110034 110083 110140 110336 110009 110129 110072 110037 110169 110014 110212 110287 110130 110332 110333 110233 110340 110133 110341 110208 110143 110314 110170 110275 110260 110109 110131 110315 110294 110146 110259 110263 110117 110077 110347 110123 110111 110189 110151 110157 110261 110297 110171 110018 110136 110267 110330 110211 110299 110071 110162 110305 110246 110300 110200 110075 110327 110326 110164 110337 110304 110085 110229 110093 110063 110199 110113 110107 110184 110172 110049 110183 110205 110036 110076 110052 110182 110289 110237 110065 110291 110288 110301 110178 110265 110159 110302 110088 110150 110293 110278 110148 110068 110078 110236 110153 110181 110241 110295 110064 110114 110058 110303 110296 110249 110266 110308 110137 110290 110285 110335 110207 110156 110069 110079 110310 110191 110110 110240 110313 110128 110245 110325 110324 110307 110317 110321 110194 110061 110142 110228 110167 110292 110342 110306 110334 110051 110177 110206 110017 110108 110008 110120 110264 110257 110180 110329 110060 110106 110038 110013 110081 110311 110040 110028 110125 110179 110053 110115 110033 110031 110283 110074 110165 110195 110217 110187 110002 110161 110160 110144 110006 110098 110175 110050 110025 110225 110204 110210 110262 110214 110067 110222 110047 110198 110202 110193 110012 110149 110048 110349 110221 110318 110097 110203 110239 110119 110090 110298 110215 110244 110258 110277 110084 110256 110007 110312 110023 110132 110201 110027 110322 110343 110016 110145 110320 110056 110026 110250 110039 110190 110282 110216 110066 110029 110035 110209 110242 110280 110281 110091 110346 110286 110284 110099 110094 110186 110122 110105 110272 110185 110331 110168 110248 110273 110054 110155 110234 110020 110243 110174 110041 110100 110271 110059 110116 110251 110188 110224 110255 110230 110042 110252 110309 110135 110238 110247 110134 110073 110015 110095 110101 110316 110218 110220 110219 110045 110024 110328 110268 110154 110173 110152 110092 110176 110057 110276 110087 110138 110086 110269 110127 110213 110166 110005 110030 110227 110003 110022 110104 110323 110139 110032 110254 110339 110019 110112 110118 110082 110141 110089 110348 110223 110192 110046 110196 110103 110004 110096 110253 110044 110021, and 110158.
Recalling Firm/
Manufacturer
TomoTherapy Incorporated
1240 Deming Way
Madison, Wisconsin 53717
Manufacturer Reason
for Recall
It was determined that the Treatment Planning Station (TPS) can potentially under dose.
FDA Determined
Cause 2
DESIGN: Software Design
Action Consignees were sent a TomoTherapy "Field Safety Notice Medical Device Correction" letter dated January 26, 2011. The letter was addressed to "TomoTherapy Customer". The letter described the Planning Issue, Related DQA Consideration, Graphical Presentation of Results, Product Affected, Recommended Action and Resolution. The letter suggests to use the information presented in order to avoid creating plans with an increased potential for discrepancies in planned vs. delivered dose. Specifically include measurements for small, off-axis targets that could be susceptible to the effects of this issue. DQA dose measurements should be performed at each unique full fraction dose that will be used for patient treatment, without using DQA scaling. If Customers have any questions they are to contact TomoTherapy Interaction Center by email or phone.
Quantity in Commerce 326
Distribution Worldwide Distribution -- US, including States of: AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, HI, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MO, MT, NE, NV, NJ, NM, NY ,NC, ND,OH, OK OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, and WY and countries of SPAIN, GERMANY, FRANCE, INDIA, KOREA, SWEDEN, ITALY, MALAYSIA, SWITZERLAND, CANADA, UNITED KINGDOM, SINGAPORE, TURKEY, TAIWAN, AUSTRALIA, JAPAN, BELGIUM, CHINA, MEXICO, NETHERLANDS, POLAND, SAUDI ARABIA, and UNITED ARAB EMIRATES.
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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