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U.S. Department of Health and Human Services

Class 2 Device Recall Clinac Linear Accelerators

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  Class 2 Device Recall Clinac Linear Accelerators see related information
Date Initiated by Firm May 24, 2011
Date Posted July 28, 2011
Recall Status1 Terminated 3 on March 14, 2012
Recall Number Z-2893-2011
Recall Event ID 59088
510(K)Number K100890  
Product Classification Accelerator, linear, medical - Product Code IYE
Product Clinac Linear Accelerators;
Varian Medical Systems, Palo Alto, CA.

Radiation Therapy intended to deliver megavoltage x-ray treatments for conventional radiotherapy and stereotactic radiosurgery and radiotherapy.
Code Information Model # H14, H27 and H29: Serial Numbers:  H080002 H080038 H080070 H080099 H080131 H080162 H080188 H080216 H080250 H080282 H080314 H082013 H080004 H080039 H080071 H080100 H080132 H080163 H080189 H080217 H080251 H080283 H080315 H082014 H080005 H080040 H080072 H080103 H080133 H080164 H080190 H080218 H080252 H080286 H080316 H082015 H080006 H080041 H080073 H080104 H080134 H080165 H080191 H080220 H080255 H080287 H080317 H080008 H080042 H080074 H080105 H080136 H080166 H080192 H080221 H080256 H080288 H080318 H080010 H080043 H080075 H080107 H080137 H080167 H080193 H080222 H080258 H080289 H080319 H080011 H080044 H080076 H080108 H080138 H080168 H080194 H080224 H080260 H080291 H080321 H080012 H080045 H080077 H080109 H080139 H080169 H080195 H080225 H080261 H080292 H080322 H080013 H080046 H080078 H080110 H080140 H080170 H080196 H080226 H080262 H080295 H080324  H080014 H080047 H080079 H080111 H080141 H080172 H080197 H080227 H080263 H080296 H080325 H080016 H080048 H080080 H080113 H080142 H080173 H080198 H080228 H080264 H080297 H080326 H080017 H080050 H080081 H080114 H080143 H080174 H080199 H080229 H080265 H080298 H080327 H080020 H080051 H080082 H080115 H080145 H080175 H080200 H080230 H080266 H080299 H080328 H080022 H080052 H080083 H080116 H080147 H080176 H080202 H080231 H080267 H080301 H082000 H080024 H080054 H080084 H080117 H080148 H080177 H080203 H080234 H080268 H080302 H082001  H080025 H080055 H080085 H080118 H080149 H080178 H080204 H080235 H080269 H080303 H082002 H080026 H080057 H080086 H080119 H080151 H080179 H080205 H080236 H080270 H080304 H082003 H080027 H080059 H080087 H080120 H080152 H080180 H080206 H080237 H080271 H080305 H082005 H080028 H080060 H080089 H080121 H080154 H080181 H080207 H080238 H080272 H080306 H082006 H080030 H080061 H080090 H080122 H080155 H080182 H080209 H080239 H080273 H080307 H082007 H080031 H080062 H080091 H080124 H080156 H080183 H080210 H080240 H080274 H080309 H082008  H080032 H080064 H080093 H080125 H080158 H080184 H080211 H080243 H080275 H080310 H082009 H080033 H080065 H080094 H080128 H080159 H080185 H080212 H080246 H080276 H080311 H082010 H080034 H080066 H080095 H080129 H080160 H080186 H080213 H080247 H080280 H080312 H082011 H080035 H080068 H080097 H080130 H080161 H080187 H080215 H080248 H080281 H080313 H082012.  
Recalling Firm/
Manufacturer		 Varian Medical Systems, Inc. Oncology Systems
911 Hansen Way
Palo Alto CA 94304-1028
For Additional Information Contact Michael Pignataro
650-424-5731
Manufacturer Reason
for Recall		 The throat cover on the High Energy Clinac may detach if not properly installed and possibly strike a patient.
FDA Determined
Cause 2		 Device Design
Action Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated May 24, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter provides directions on how to re-install the gantry center throat cover. Customers can contact their Varian Customer Support Manager at 1-888-827-4265 for further clarification.
Quantity in Commerce 278
Distribution Worldwide Distribution-including USA (nationwide)
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 = IYE and Original Applicant = VARIAN MEDICAL SYSTEMS
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