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U.S. Department of Health and Human Services

Class 2 Device Recall Eclipse Treatment Planning System

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  Class 2 Device Recall Eclipse Treatment Planning System see related information
Date Initiated by Firm November 18, 2013
Date Posting Updated December 20, 2013
Recall Status1 Terminated 3 on March 13, 2015
Recall Number Z-0552-2014
Recall Event ID 66956
510(K)Number K131807  K093527  
Product Classification System,planning,radiation therapy treatment - Product Code MUJ
Product Plan Parameters workspace within
Eclipse Treatment Planning System Version 11 and 13;
ARIA Radiation Oncology versions 11 and 13
Acuity, versions 11 and 13.

Manufactured by Varian Medical Systems
Palo Alto, CA.

Used in radiation therapy simulation.
Code Information 2, H485213 H485482 H485667 H485854 H486142 H486261 H486424 H486664 H486932 H487153 H487330 H487620 H487834, H485214 H485483 H485675 H485855 H486143 H486262 H486425 H486666 H486933 H487154 H487333 H487621 H487835, H485215 H485489 H485676 H485856 H486144 H486263 H486426 H486686 H486934 H487155 H487351 H487623 H487836, H485216 H485491 H485684 H485874 H486145 H486264 H486427 H486688 H486937 H487156 H487380 H487624 H487837, H485217 H485495 H485685 H485886 H486146 H486265 H486428 H486689 H486938 H487157 H487394 H487625 H487838, H485218 H485496 H485686 H485887 H486147 H486266 H486429 H486690 H486939 H487158 H487395 H487626 H487839, H485232 H485497 H485689 H485888 H486148 H486269 H486435 H486691 H486940 H487159 H487396 H487627 H487840, H485233 H485498 H485690 H485889 H486149 H486270 H486442 H486693 H486941 H487160 H487404 H487639 H487841, H485234 H485499 H485691 H485890 H486150 H486285 H486443 H486694 H486957 H487164 H487405 H487640 H487842, H485244 H485500 H485694 H485891 H486151 H486286 H486444 H486701 H486972 H487165 H487406 H487641 H487865, H485247 H485501 H485695 H485892 H486152 H486289 H486445 H486702 H486981 H487166 H487419 H487642 H487866, H485248 H485502 H485701 H485893 H486153 H486290 H486446 H486703 H486982 H487167 H487420 H487643 H487867, H485249 H485503 H485702 H485894 H486154 H486291 H486447 H486704 H486983 H487168 H487428 H487644 H487871, H485257 H485504 H485706 H485895 H486155 H486296 H486448 H486708 H487011 H487169 H487430 H487645 H487875, H485258 H485505 H485707 H485896 H486156 H486297 H486449 H486714 H487012 H487170 H487433 H487647 H487885, H485268 H485506 H485708 H485897 H486157 H486300 H486472 H486715 H487013 H487171 H487436 H487664 H487889, H485269 H485507 H485716 H485898 H486158 H486304 H486473 H486716 H487014 H487172 H487437 H487665 H487890, H485270 H485508 H485729 H485899 H486159 H486308 H486474 H486759 H487015 H487173 H487440 H487666 H487891, H485271 H485509 H485731 H485900 H486160 H486311 H486475 H486760 H487029 H487174 H487466 H487667 H487892, H485272 H485510 H485743 H485931 H486161 H486312 H486486 H486769 H487030 H487175 H487467 H487668 H487895, H485273 H485511 H485744 H485932 H486162 H486314 H486498 H486783 H487040 H487176 H487468 H487669 H487900, H485274 H485512 H485745 H485936 H486163 H486315 H486499 H486797 H487066 H487184 H487470 H487670 H487902, H485275 H485513 H485746 H485937 H486164 H486322 H486503 H486805 H487067 H487185 H487488 H487671 H487906, H485283 H485514 H485751 H485938 H486165 H486323 H486509 H486806 H487068 H487186 H487489 H487672 H487912, H485284 H485515 H485752 H485939 H486166 H486324 H486517 H486816 H487069 H487189 H487490 H487676 H487914, H485286 H485517 H4857SS H485943 H486167 H486325 H486518 H486817 H487070 H487190 H487491 H487698 H487915, H485296 H485529 H485756 H485944 H486168 H486326 H486520 H486826 H487071 H487191 H487500 H487699 H487916, H485297 H485530 H485757 H485945 H486169 H486327 H486543 H486827 H487072 H487192 H487501 H487700 H487917, H487934 H488248 H488536 H488883 H489202 H489469 H489764 H48A117 H48A349 H48A658 H48A805 H48B036 H48B332, H487941 H488249 H488537 H488884 H489213 H489470 H489765 H48A124 H48A362 H48A659 H48A806 H48B037 H48B333, H487950 H488254 H488541 H488885 H489215 H489471 H489766 H48A126 H48A363 H48A660 H48A807 H48B038 H48B334, H487974 H48825S H488547 H488886 H489217 H489516 H489767 H48A147 H48A364 H48A661 H48A808 H48B043 H48B356, H487975 H488256 H488548 H488892 H489232 H489517 H489768 H48A148 H48A36S H48A662 H48A809 H488046 H48B357, H487976 H488257 H488558 H488903 H489247 H489518 H489792 H48A149 H48A366 H48A663 H48A810 H48B047 H48B358, H487980 H488258 H488559 H488913 H489248 H489519 H489793 H48A150 H48A367 H48A664 H48A812 H48BOS6 H488359, H487981 H488261 H488560 H488917 H489249 H489528 H489794 H48A151 H48A368 H48A667 H48A813 H48B057 H48B360, H487982 H488270 H488561 H488928 H489250 H489529 H489795 H48A152 H48A369 H48A668 H48A816 H48BOS8 H48B361, H487983 H488276 H488566 H488942 H489257 H489560 H489796 H48A153 H48A370 H48A679 H48A817 H48B063 H48B364, H487992
Recalling Firm/
Varian Medical Systems, Inc.
911 Hansen Way
Palo Alto CA 94304-1028
For Additional Information Contact K. Jeffrey Semone
Manufacturer Reason
for Recall
An anomaly has been traced to a software deficiency within the Plan Parameters workspace. When a dose relevant parameter is changed and "do no clear MUs and Reference Point dose" is selected, the Monitor units may change.
FDA Determined
Cause 2
Software design
Action Varian Medical Systems will provide all affected consignees with an Urgent Medical Device Correction Letter commencing on November 18, 2013 by federal express. . The Letter will also be distributed to the Varian Sales, Marketing, and Service organizations, informing them of the reported issue.
Quantity in Commerce 6701
Distribution Worldwide Distribution.
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 = MUJ and Original Applicant = VARIAN MEDICAL SYSTEMS, INC.