Varian brand Trilogy System with RapidArc, Model Numbers: H14, H26, H27, H29; Distributed and Manufactured by: Varian Medical Systems Inc., Palo Alto, CA
This recall has been terminated (originally issued December 28, 2010).
- Company
- Varian Medical Systems, Inc.
- Recall Initiated
- July 20, 2010
- Posted
- December 28, 2010
- Terminated
- July 18, 2011
- Recall Number
- Z-0821-2011
- Firm Location
- Palo Alto, CA
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
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
Root Cause
Software design
Action Taken
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.