Z-0821-2011

Varian brand Trilogy System with RapidArc, Model Numbers: H14, H26, H27, H29; Distributed and Manufactured...

Name: Z-0821-2011 Varian brand Trilogy System with RapidArc, Model Numbers: H14, H26, H27, H29; Distributed and Manufactured...
Creator: Varian Medical Systems Inc.
Published: 2010-07-20
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2010-07-20 / Terminated / root cause: software

FDA source

Varian Medical Systems Inc. began a recall of Varian brand Trilogy System with RapidArc, Model Numbers: H14, H26, H27, H29; Distributed and Manufactured by: Varian Medical Systems Inc., Palo Alto, CA on 2010-07-20. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0821-2011
Status: Terminated
Initiated: 2010-07-20
Posted: 2010-12-28
Terminated: 2011-07-18
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
Product code: IYE Accelerator, Linear, Medical
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.
Root cause tag: software
FDA 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.
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.
Product codes and lots: 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

Product code IYE

K072916Class IITrilogy System with RapidarcVarian Medical Systems, Inc. / cleared 2007-11-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)