Class 2 Device Recall TomoTherapy HiArt System

• Date Initiated by Firm: July 13, 2011
• Date Posted: August 31, 2011
• Recall Status: Terminated on March 18, 2014
• Recall Number: Z-3108-2011
• Recall Event ID: 59439
• 510(K)Number: K082005
• Product Classification: system,planning,radiation therapy treatment - Product Code MUJ
• Product: Hi¿Art versions 4.0.x, and HD versions 1.0.x, H-0000-0003.; ; The TomoTherapy HI-ART System is intended to be used as an integrated system for the 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. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan.
• Code Information: 110002 110056 110110 110162 110214 110267 110319 110003 110057 110111 110164 110215 110268 110320 110004 110058 110112 110165 110216 110269 110321 110005 110059 110113 110166 110217 110271 110322 110006 110060 110114 110167 110218 110272 110323 110007 110061 110115 110168 110219 110273 110324 110008 110063 110116 110169 110220 110275 110325 110009 110064 110117 110170 110221 110276 110326 110012 110065 110118 110171 110222 110277 110327 110013 110066 110119 110172 110223 110278 110328 110014 110067 110120 110173 110224 110279 110329 110015 110068 110122 110174 110225 110280 110330 110016 110069 110123 110175 110227 110281 110331 110017 110071 110124 110176 110228 110282 110332 110018 110072 110125 110177 110229 110283 110333 110020 110073 110126 110178 110230 110284 110334 110021 110074 110127 110179 110233 110285 110335 110022 110075 110128 110180 110234 110286 110336 110023 110076 110129 110181 110235 110287 110337 110024 110077 110130 110182 110236 110288 110339 110025 110078 110131 110183 110237 110289 110340 110026 110079 110132 110184 110238 110290 110341 110027 110081 110133 110185 110239 110291 110342 110028 110082 110134 110186 110240 110292 110343 110029 110083 110135 110187 110241 110293 110344 110030 110084 110136 110188 110242 110294 110345 110031 110085 110137 110189 110243 110295 110346 110032 110086 110138 110190 110244 110296 110347 110033 110087 110139 110191 110245 110297 110348 110034 110088 110140 110192 110246 110298 110349 110035 110089 110141 110193 110247 110299 110350 110036 110090 110142 110194 110248 110300 110351 110037 110091 110143 110195 110249 110301 110352 110038 110092 110144 110196 110250 110302 110353 110039 110093 110145 110198 110251 110303 110354 110040 110094 110146 110199 110252 110304 110356 110041 110095 110148 110200 110253 110305 110357 110042 110096 110149 110201 110254 110306 110358 110044 110097 110150 110202 110255 110307 110359 110045 110098 110151 110203 110256 110308 110360 110046 110099 110152 110204 110257 110309 110363 110047 110100 110153 110205 110258 110310 110364 110048 110101 110154 110206 110259 110311 110365 110049 110103 110155 110207 110260 110312 110367 110050 110104 110156 110208 110261 110313 110369 110051 110105 110157 110209 110262 110314 110377 110052 110106 110158 110210 110263 110315 110053 110107 110159 110211 110264 110316 110054 110108 110160 110212 110265 110317 110055 110109 110161 110213 110266 110318
• Recalling Firm/ Manufacturer: Accuray Incorporated; 1240 Deming Way; Madison WI 53717-1954
• For Additional Information Contact: 608-824-2800
• Manufacturer Reason for Recall: As a result of an internal review, TomoTherapy has identified an issue with Hi¿¿Art versions 4.0.x, and HD versions 1.0.x that we would like to bring to your attention. During DICOM export of plan level images with a non square exported Field of View (FOV), an anomaly in the process of squaring the plan level image may cause the image to shift with respect to ROIs and dose. When the anomaly occu
• FDA Determined Cause: Software design
• Action: TomoTherapy sent a "Urgent Medical Device Correction" letter dated July 13, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This issue will be remedied with Hi¿¿Art software version 4.1 and HD software version 1.1 and later. If you have any questions, please contact the TomoTherapy Technical Solutions Center by e-mail "support@tomotherapy.com" . Please refer to the letter for what phone number you should call depending on where you are.
• Quantity in Commerce: 346
• Distribution: Worldwide Distribution-- USA (nationwide) including the 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, NJ, NM, NY, NC, ND, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WV, WI and WY and the countries United Arab Emirates United Kingdom Turkey Switzerland Sweden Spain Saudi Arabia Poland Netherlands Italy Germany France Belgium Taiwan Singapore Malaysia Korea Japan India Hong Kong China Australia Mexico El Salvador and Canada
• 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 = MUJ and Original Applicant = TOMOTHERAPY INCORPORATED