Recall Z-3108-2011
Accuray Incorporated · initiated July 13, 2011
Product
HiArt 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.
Codes / lots: 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…
Reason for recall
As a result of an internal review, TomoTherapy has identified an issue with HiArt 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 taken
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 HiArt 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.
Details
- Recall number
- Z-3108-2011
- Initiated
- July 13, 2011
- Posted by FDA
- August 31, 2011
- Terminated
- March 18, 2014
- Product code
- MUJ – System, Planning, Radiation Therapy Treatment
- Quantity
- 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…
- Recalling firm
- Accuray Incorporated, Madison, WI