Class 2 Device Recall Varian Trilogy System with RapidArc

• Date Initiated by Firm: July 20, 2010
• Date Posted: December 28, 2010
• Recall Status: Terminated on July 18, 2011
• Recall Number: Z-0821-2011
• Recall Event ID: 56774
• 510(K)Number: K072916
• Product Classification: Accelerator, linear, medical - Product Code IYE
• Product: Varian brand Trilogy System with RapidArc, Model Numbers: H14, H26, H27, H29; Distributed and Manufactured by: Varian Medical Systems Inc., Palo Alto, CA
• Code Information: H140025,H140753,H140845,H140896,H272157 ,H272963 ,H291040 ,H291187 ,H293443 ,H293691,H140038 ,H140769,H140846 ,H140901 ,H272158 ,H272981,H291048,H291190 ,H293447 ,H293696,H140045 ,H140772 ,H140848 ,H140902 ,H272165 ,H272982,H291050 ,H291206 ,H293475 ,H293700,H140047 ,H140773,H140849 ,H140904,H272178,H272985 ,H291051,H291226 ,H293496 ,H293709 ,H140078 ,H140777 ,H140850 ,H140906 ,H272187 ,H273049 ,H291053 ,H291230 ,H293507 ,H293725 ,H140092 ,H140780 ,H140851 ,H182012 ,H272188 ,H273065 ,H291060 ,H291234 ,H293519 ,H293726 ,H140096 ,H140781 ,H140853 ,H271167 ,H272216 ,H273162 ,H291067 ,H291242 ,H293538 ,H293727 ,H140097 ,H140783 ,H140854 ,H271370 ,H272220 ,H273170 ,H291072 ,H291247 ,H293541 ,H293728 ,H140122 ,H140787 ,H140855 ,H271378 ,H272231 ,H273202 ,H291081 ,H291248 ,H293560 ,H293736 ,H140124 ,H140790 ,H140856 ,H271385 ,H272309 ,H273203 ,H291084 ,H291251 ,H293565 ,H293737 ,H140125 ,H140794 ,H140857 ,H271531 ,H272310 ,H290278 ,H291088 ,H291253 ,H293577 ,H293749 ,H140144 ,H140795 ,H140858 ,H271588 ,H272325 ,H290282 ,H291096 ,H291254 ,H293581 ,H293769 ,H140146 ,H140797 ,H140863 ,H271607 ,H272360 ,H290362 ,H291099 ,H291262 ,H293592 ,H293773 ,H140148 ,H140799 ,H140864 ,H271618 ,H272377 ,H290399 ,H291107 ,H291270 ,H293596 ,H293774 ,H140201 ,H140800 ,H140865 ,H271662 ,H272401 ,H290400 ,H291115 ,H291271 ,H293611 ,H293775 ,H140202 ,H140801 ,H140866 ,H271663 ,H272426 ,H290402 ,H291116 ,H291272 ,H293624 ,H293778 ,H140206 ,H140808 ,H140867 ,H271729 ,H272427 ,H290501 ,H291117 ,H293312 ,H293627 ,H293779 ,H140214 ,H140812 ,H140868 ,H271785 ,H272440 ,H290503 ,H291118 ,H293325 ,H293632 ,H293780 ,H140216 ,H140816 ,H140869 ,H271825 ,H272456 ,H290510 ,H291119 ,H293327 ,H293636 ,H293781 ,H140218 ,H140817 ,H140871 ,H271890 ,H272473 ,H290512 ,H291124 ,H293335 ,H293638 ,H293790 ,H140222 ,H140818 ,H140874 ,H271906 ,H272491 ,H290519 ,H291133 ,H293342 ,H293642 ,H293802 ,H140223 ,H140819 ,H140876 ,H271926 ,H272497 ,H291007 ,H291136 ,H293353 ,H293644 ,H293804 ,H140224 ,H140820 ,H140877 ,H271941 ,H272500 ,H291008 ,H291138 ,H293361 ,H293646 ,H293805 ,H140233 ,H140824 ,H140881 ,H271951 ,H272826 ,H291011 ,H291143 ,H293363 ,H293649 ,H293818 ,H140240 ,H140826 ,H140882 ,H271954 ,H272834 ,H291014 ,H291149 ,H293370 ,H293650 ,H293820 ,H140718 ,H140829 ,H140883 ,H271994 ,H272842 ,H291017 ,H291154 ,H293379 ,H293652 ,H293825 ,H140719 ,H140830 ,H140886 ,H272000 ,H272873 ,H291019 ,H291159 ,H293401 ,H293653 ,H293829 ,H140721 ,H140832 ,H140887 ,H272014 ,H272885 ,H291021 ,H291169 ,H293411 ,H293657 ,H293830 ,H140741 ,H140836 ,H140889 ,H272016 ,H272908 ,H291022 ,H291170 ,H293414 ,H293662 ,H293835 ,H140742 ,H140840 ,H140891 ,H272029 ,H272910 ,H291025 ,H291171 ,H293431 ,H293663 ,H293839 ,H140747 ,H140841 ,H140892 ,H272064 ,H272933 ,H291028 ,H291172 ,H293433 ,H293664 ,H293841 ,H140749 ,H140843 ,H140893 ,H272081 ,H272946 ,H291035 ,H291178 ,H293438 ,H293686 ,H293846 ,H140751 ,H140844 ,H140895 ,H272111 ,H272960 ,H291037 ,H291184 ,H293439 ,H293690 ,H293847,H293848 ,H294007 ,H294135 ,H294244 ,H294332 ,H294415 ,H294500 ,H294567 ,H294656 ,H294732 ,H293860 ,H294012 ,H294140 ,H294246 ,H294338 ,H294418 ,H294501 ,H294568 ,H294657 ,H294735 ,H293866 ,H294013 ,H294141 ,H294248 ,H294340 ,H294420 ,H294505 ,H294569 ,H294658 ,H294739 ,H293872 ,H294020 ,H294146 ,H294252 ,H294342 ,H294423 ,H294508 ,H294571 ,H294660 ,H294742 ,H293875 ,H294022 ,H294149 ,H294256 ,H294343 ,H294425 ,H294509 ,H294572 ,H294661 ,H294744 ,H293878 ,H294023 ,H294150 ,H294263 ,H294345 ,H294426 ,H294513 ,H294573 ,H294665 ,H294745 ,H293880 ,H294024 ,H294155 ,H294264 ,H294347 ,H294427 ,H294514 ,H294581 ,H294666 ,H294747 ,H293886 ,H294032 ,H294157 ,H294265 ,H294348 ,H294429 ,H294517 ,H294587 ,H294667 ,H294750 ,H293888 ,H294033 ,H294158 ,H294266 ,H294350 ,H294430 ,H294518 ,H294589 ,H294668 ,H294752 ,H293889 ,H294035 ,H294162 ,H294267 ,H294351 ,H294431 ,H294520 ,H294590 ,H294671 ,H294753 ,H293890 ,H294037 ,H294163 ,H294268 ,H294352 ,H294433 ,H294521 ,H294591 ,H294674 ,H294754,H293899 ,H294043 ,H294164 ,H294272 ,H294355 ,H294434 ,H294523 ,H294593 ,H294675 ,H294758 ,H293902 ,H294048 ,H294166 ,H294278 ,H294362 ,H294436 ,H294524 ,H294594 ,H294676 ,H294761 ,H293903 ,H294053 ,H294167 ,H294279 ,H294363 ,H294437 ,H294528 ,H294595 ,H294678 ,H294762 ,H293906 ,H294055 ,H294169 ,H294282 ,H294364 ,H294438 ,H294530 ,H294598 ,H294679 ,H294763 ,H293908 ,H294057 ,H294171 ,H294284 ,H294366 ,H294443 ,H294531 ,H294603 ,H294681 ,H294766 ,H293909 ,H294061 ,H294176 ,H294290 ,H294369 ,H294447 ,H294534 ,H294604 ,H294682 ,H294768 ,H293917 ,H294062 ,H294178 ,H294292 ,H294370 ,H294449 ,H294535 ,H294608 ,H294683 ,H294770 ,H293918 ,H294070 ,H294179 ,H294295 ,H294371 ,H294450 ,H294536 ,H294613 ,H294684 ,H294771 ,H293919 ,H294081 ,H294180 ,H294296 ,H294373 ,H294460 ,H294537 ,H294614 ,H294694 ,H294782 ,H293925 ,H294082 ,H294188 ,H294297 ,H294376 ,H294461 ,H294538 ,H294615 ,H294696 ,H294786 ,H293928 ,H294083 ,H294190 ,H294300 ,H294381 ,H294465 ,H294539 ,H294616 ,H294697 ,H294792 ,H293946 ,H294087 ,H294200 ,H294302 ,H294382 ,H294468 ,H294540 ,H294618 ,H294698 ,H294793 ,H293947 ,H294099 ,H294202 ,H294303 ,H294385 ,H294469 ,H294541 ,H294620 ,H294701 ,H294796 ,H293952 ,H294100 ,H294203 ,H294306 ,H294386 ,H294470 ,H294542 ,H294621 ,H294705 ,H294797 ,H293953 ,H294102 ,H294204 ,H294307 ,H294387 ,H294472 ,H294545 ,H294623 ,H294707 ,H294798 ,H293954 ,H294104 ,H294206 ,H294311 ,H294393 ,H294474 ,H294546 ,H294625 ,H294711 ,H294801 ,H293955 ,H294105 ,H294207 ,H294316 ,H294394 ,H294476 ,H294547 ,H294626 ,H294712 ,H294803 ,H293957 ,H294106 ,H294210 ,H294317 ,H294395 ,H294477 ,H294548 ,H294630 ,H294715 ,H294806 ,H293960 ,H294111 ,H294212 ,H294319 ,H294397 ,H294478 ,H294549 ,H294632 ,H294716 ,H294807 ,H293964 ,H294114 ,H294213 ,H294320 ,H294398 ,H294479 ,H294550 ,H294637 ,H294719 ,H294808 ,H293971 ,H294118 ,H294215 ,H294321 ,H294401 ,H294482 ,H294551 ,H294640 ,H294720 ,H294813 ,H293981 ,H294122 ,H294216 ,H294322 ,H294402 ,H294488 ,H294552 ,H294643 ,H294723 ,H294815 ,H293984 ,H294126 ,H294219 ,H294325 ,H294403 ,H294493 ,H294553 ,H294644 ,H294724 ,H294826 ,H293989 ,H294128 ,H294224 ,H294326 ,H294404 ,H294494 ,H294554 ,H294645 ,H294726 ,H294827 ,H293993 ,H294130 ,H294227 ,H294329 ,H294406 ,H294497 ,H294556 ,H294646 ,H294727 ,H294829 ,H294002 ,H294133 ,H294232 ,H294330 ,H294409 ,H294498 ,H294557 ,H294652 ,H294728,H294004 ,H294134 ,H294238 ,H294331 ,H294414 ,H294499 ,H294565 ,H294654 ,H294729
• FEI Number: 2916710
• Recalling Firm/ Manufacturer: Varian Medical Systems Inc.; 911 Hansen Way; Palo Alto CA 94304-1028
• For Additional Information Contact: Dave Hall ; 650-424-5731
• Manufacturer Reason for Recall: The system may deliver an inaccurate dose that does not match the treatment plan. As a result of a system configuration problem, the VMAT (Volumetric Modulated Arc Therapy) plans may be delivered as Dynamic Arc therapy plans. If this occurs, the VMAT plan will not be recognized. This issue affects Trilogy machines with the Rapid Arc Treatment delivery option.
• FDA Determined Cause: Software design
• Action: Varian issued Urgent Medical Device Correction letters dated July 20, 2010 to its direct consignees, informing them of the affected product and providing instructions on the actions to be taken. These instruction include: if the unit does not display "RapidArc" or "VMAT" under Treatment Type during dose delivery, discontinue use of the device and call Varian service. Varian Service Help Desk can be contacted at 1-888-827-4265.
• Distribution: Worldwide Distributiuon: Throughout the US, and the countries of Australia, Canada, China, Japan, and New Zealand, and in the regions of North and Latin America, Europe, and South East Asia.
• 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