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U.S. Department of Health and Human Services

Class 2 Device Recall Radiation Therapy System

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 Class 2 Recall
Radiation Therapy System
see related information
Date Posted January 22, 2009
Recall Status1 Open
Recall Number Z-0628-2009
Recall Event ID 50147
Premarket Notification
510(K) Number
K060912 
Product Classification Accelerator, Linear, Medical - Product Code IYE
Product TomoTherapy HI-ART Systems with versions 2.2.4, 3.1.2, 3.1.3 or 3.2.1 software. The affected applications include Planning Station, Planned Adaptive, Data Management System, and TomoPortal. TomoTherapy HI-ART Systems 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 health tissue. The HI-Art system's planning station or operator station is intended to be used by the physician/oncologists to prescribe a radiation therapy plan for a particular patient,. The HI-ART System then calculates the treatment plan which the physician reviews and approves. The HI-ART system's operator station and status console is then intended to be used by the therapist to select and implement the patient's treatment plan. The treatment process will begin by performing a TomoImage (MVCT) scan (a CT using the on board linear accelerator as the radiation source). This TomoImage (MVCT) will confirm that the patient's position is correct for the radiation therapy as well as assist in patient re-positioning when necessary. The TomoImage (MVCT) image is not for diagnostic use. When patient positioning is complete, the HI-ART System i sthen intended to be used by the therapist to treat the patient using the selected treatment plan. The HI-ART System delivers the radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment in accordance with the physician approved plan delivered in a helical tomographic pattern.
Code Information Domestic Customer Information Serial number: 110001 110002 110003 110004 110005 110006 110007 110008 110012 110013 110015 110016 110017 110019 110020 110021 110022 110023 110024 110025 110026 110027 110028 110029 110030 110031 110032 110033 110035 110038 110039 110040 110041 110042 110043 110044 110045 110047 110048 110050 110051 110053 110054 110056 110057 110059 110060 110066 110067 110073 110074 110080 110081 110082 110084 110086 110087 110089 110090 110091 110092 110094 110095 110096 110097 110098 110100 110103 110104 110105 110106 110108 110112 110115 110116 110118 110119 110120 110122 110127 110132 110134 110135 110138 110139 110141 110144 110145 110148 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 110214 110215 110216 110217 110221 110222 110223 110225 110227 110238 110242 110224 and 110250. International Customer Information Serial number: 110009 110014 110018 110034 110036 110037 110046 110049 110052 110055 110058 110061 110062 110063 110064 110065 110068 110069 110071 110072 110075 110076 110077 110078 110079 110083 110085 110088 110093 110107 110109 110110 110111 110113 110114 110117 110123 110124 110126 110128 110129 110130 110131 110133 110136 110137 110140 110142 110143 110146 110150 110151 110156 110157 110159 110162 110164 110167 110169 110170 110171 110172 110178 110182 110183 110189 110191 110194 110199 110200 110207 110211 110228 110237 and 110240.
Recalling Firm/
Manufacturer
TomoTherapy Incorporated
1240 Deming Way
Madison, Wisconsin 53717
Manufacturer Reason
for Recall
TomoTherapy Incorporated identified a potential issue with the Hi-Art system during the course of ongoing testing. The Operator Station Calibration panel provides access to view and modify machine specific configuration settings. Access to these settings has always been restricted to individuals with appropriate security rights, being limited to only the "Superuser" and "Field Service engine
FDA Determined
Cause 2
DESIGN: Software Design
Action A TomoTherapy Incorporated "Urgent Medical Device Correction Field Safety Notice" letter dated October 17, 2008 was sent to all consignees. The letter addressed the Issue, Product Affected, Recommended Actions and Resolution. Please direct questions to the TomoTherapy, Inc. Customer Care Center by email (www.support@tomotherapy.com) or by telephone, North America: 1-866-368- 4807 and all other locations: 1-608-824-2900 or 32-2-400-44-44.
Quantity in Commerce 215
Distribution Worldwide Distribution --- USA including states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, IL, IN, IA, KY, LA, MD, MA, MI, MN, MO, NE, NV, NJ, NM, NY, OH,OK , OR, PR, PA, SC, SD, TN, TX, VA, WA, WI, WY, and DC, and countries of BELGIUM, CANADA, SWITZERLAND, CHINA, GERMANY, SPAIN, FRANCE, GREAT BRITAIN, HONG KONG, ITALY, JAPAN, KOREA, NETHERLANDS, SINGAPORE, TAIWAN and TURKEY.
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 = IYE and Original Applicant = TOMOTHERAPY INCORPORATED
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