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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 Device Recall Radiation Therapy System see related information
Date Posted January 22, 2009
Recall Status1 Terminated on February 10, 2011
Recall Number Z-0628-2009
Recall Event ID 50147
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 WI 53717
608-824-2800
For Additional Information Contact
608-824-2800
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
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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