TomoTherapy Incorporated 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
TomoTherapy Incorporated
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
TomoTherapy Incorporated is recalling TomoTherapy HI-ART Systems with 3.1.2, 3.1.3 or 3.2.1 software. The affected applications include Pl due to TomoTherapy Inc. discovered an issue on the Hi-Art system during the course of ongoing testing. It has been identified that treatment plans involvin. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AZ, AR, CA, CO, CT, FL, HI, IL, IN, IA, KY, LA, MD, MA, MI, MN, MO, NE, NV, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WY, DC, PR
Page updated: Jan 10, 2026