Varian Medical Systems Inc.: Varian brand Trilogy System with RapidArc, Model Numbers: H14, H26, H27, H29; Distributed and Manufactured by: Varian Medical Systems Inc., Palo Alto, CA

Recall number

Z-0821-2011

Recalling firm

Varian Medical Systems Inc.

Product

Varian brand Trilogy System with RapidArc, Model Numbers: H14, H26, H27, H29; Distributed and Manufactured by: Varian Medical Systems Inc., Palo Alto, CA

Status

Terminated

Initiated

2010-07-20

Posted

2010-12-28

Terminated

2011-07-18

Reason

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.

Root 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.

Quantity

not on file

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, serial or model codes

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

510(k) numbers

["K072916"]

PMA numbers

not on file

Product code

IYE

Firm FEI

2916710

Firm city

Palo Alto

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy