Varian Medical Systems Oncology Systems: Varian brand C-Series Ximatron Radiotherapy Treatment Stimulator, Model H72, Product is manufactured and distributed by Varian Oncology Systems, Palo Alto, CA The product is indicated for use in radiation therapy simulation, using a fluoroscopic and/or radiographic x-ray system for visualizing the volume to be exposed during radiation therapy.

Recall number

Z-0892-2011

Recalling firm

Varian Medical Systems Oncology Systems

Product

Varian brand C-Series Ximatron Radiotherapy Treatment Stimulator, Model H72, Product is manufactured and distributed by Varian Oncology Systems, Palo Alto, CA The product is indicated for use in radiation therapy simulation, using a fluoroscopic and/or radiographic x-ray system for visualizing the volume to be exposed during radiation therapy.

Status

Terminated

Initiated

2010-01-19

Posted

2011-01-11

Terminated

2012-02-24

Reason

There is a potential for failure of a lead screw drive system or image intensifier lead screw drive assembly, if normal maintenance inspections are not followed correctly.

Root cause

Other

Action

Varian sent an URGENT MEDICAL DEVICE CORRECTION letter via certified mail receipt on January 19, 2010, to all direct consignees. The letter identified the product, the problem, and the action the consignee should take. Consignees were instructed to have maintenance personnel perform the recommended measurements as described in the Varian Customer Technical Bulletin. Ensure that all measurements made as part of the procedure are recorded in the 'wear table' that is part of the procedure. Previous wear measurements should be compared to new measurements and any large increase in wear should be investigated immediately. Pay special attention to the "Recommendations based on wear measurements" table. Ensure that new wear measurements comply with the operating parameters described in the table. For any questions consignees are to contact Varian Medical Systems Customer Support Services at one of the locations described in the CTB. For questions regarding this recall call (650) 424-5731.

Quantity

not on file

Distribution

Worldwide Distribution including USA, Australia, New Zealand, Europe, Southeast Asia, China, Japan, Latin America, and Canada.

Lot, serial or model codes

Listed are the affected system Serial Numbers. The last four digits represent the serial number of the device.  H720003 ,H720119 ,H720209 ,H720270 ,H720347 ,H720416 ,H720491 ,H720557 ,H720618, H720006 ,H720122 ,H720210 ,H720271 ,H720348 ,H720417 ,H720495 ,H720558 ,H720620, H720009 ,H720123 ,H720211 ,H720273 ,H720350 ,H720419 ,H720496 ,H720559 ,H720622, H720013 ,H720124 ,H720213 ,H720274 ,H720351 ,H720422 ,H720498 ,H720560 ,H720624, H720015 ,H720125 ,H720215 ,H720276 ,H720352 ,H720424 ,H720499 ,H720561 ,H720626, H720017 ,H720129 ,H720217 ,H720279 ,H720353 ,H720425 ,H720500 ,H720562 ,H720627, H720021 ,H720132 ,H720218 ,H720280 ,H720354 ,H720427 ,H720501 ,H720563 ,H720628, H720022 ,H720133 ,H720219 ,H720281 ,H720355 ,H720429 ,H720502 ,H720565 ,H720629, H720025 ,H720134 ,H720221 ,H720282 ,H720357 ,H720432 ,H720503 ,H720566 ,H720632, H720035 ,H720137 ,H720222 ,H720283 ,H720358 ,H720435 ,H720505 ,H720567 ,H720637, H720037 ,H720138 ,H720225 ,H720284 ,H720362 ,H720437 ,H720506 ,H720568 ,H720638, H720040 ,H720140 ,H720229 ,H720288 ,H720363 ,H720438 ,H720508 ,H720571 ,H720639, H720041 ,H720143 ,H720230 ,H720289 ,H720367 ,H720439 ,H720509 ,H720572 ,H720641, H720048 ,H720144 ,H720231 ,H720290 ,H720373 ,H720440 ,H720511 ,H720573 ,H720642, H720051 ,H720145 ,H720232 ,H720292 ,H720374 ,H720442 ,H720513 ,H720575 ,H720643, H720052 ,H720148 ,H720233 ,H720293 ,H720375 ,H720443 ,H720514 ,H720577 ,H720644, H720056 ,H720152 ,H720234 ,H720294 ,H720376 ,H720445 ,H720515 ,H720578 ,H720647, H720057 ,H720154 ,H720235 ,H720295 ,H720379 ,H720447 ,H720516 ,H720579 ,H720648, H720059 ,H720157 ,H720236 ,H720296 ,H720383 ,H720449 ,H720518 ,H720584 ,H720650, H720060 ,H720159 ,H720237 ,H720297 ,H720384 ,H720452 ,H720522 ,H720585 ,H720651, H720064 ,H720164 ,H720239 ,H720298 ,H720386 ,H720457 ,H720523 ,H720586 ,H720653, H720069 ,H720165 ,H720241 ,H720299 ,H720388 ,H720458 ,H720525 ,H720588 ,H720654, H720070 ,H720167 ,H720242 ,H720300 ,H720391 ,H720461 ,H720526 ,H720589 ,H720659, H720071 ,H720168 ,H720245 ,H720303 ,H720392 ,H720465 ,H720528 ,H720590 ,H720660, H720072 ,H720169 ,H720247 ,H720307 ,H720394 ,H720466 ,H720530 ,H720591 ,H720661, H720074 ,H720177 ,H720248 ,H720309 ,H720395 ,H720470 ,H720531 ,H720592 ,H720663, H720075 ,H720180 ,H720251 ,H720316 ,H720396 ,H720471 ,H720533 ,H720594 ,H720664, H720082 ,H720181 ,H720254 ,H720320 ,H720397 ,H720472 ,H720534 ,H720595 ,H720666, H720083 ,H720182 ,H720255 ,H720327 ,H720399 ,H720477 ,H720536 ,H720596 ,H720667, H720088 ,H720183 ,H720256 ,H720328 ,H720402 ,H720478 ,H720537 ,H720597 ,H720668, H720089 ,H720185 ,H720257 ,H720329 ,H720403 ,H720479 ,H720539 ,H720598 ,H720669, H720092 ,H720186 ,H720258 ,H720330 ,H720404 ,H720481 ,H720546 ,H720599 ,H720670, H720098 ,H720187 ,H720261 ,H720336 ,H720405 ,H720482 ,H720547 ,H720600 ,H720671, H720101 ,H720188 ,H720262 ,H720337 ,H720406 ,H720484 ,H720548 ,H720601 ,H720672, H720106 ,H720195 ,H720263 ,H720338 ,H720407 ,H720485 ,H720550 ,H720604 ,H720673, H720107 ,H720196 ,H720264 ,H720339 ,H720409 ,H720486 ,H720553 ,H720605 ,H720674, H720108 ,H720199 ,H720265 ,H720344 ,H720411 ,H720487 ,H720554 ,H720608 ,H720675, H720112 ,H720200 ,H720266 ,H720345 ,H720414 ,H720488 ,H720555 ,H720615 ,H720676, H720113 ,H720204 ,H720269 ,H720346 ,H720415 ,H720489 ,H720556 ,H720616 ,H720678,   H720679 ,H720743 ,H720805 ,H720858 ,H720905 ,H720955 ,H721005, H720680 ,H720744 ,H720806 ,H720859 ,H720906 ,H720956 ,H721006, H720681 ,H720746 ,H720807 ,H720860 ,H720907 ,H720957 ,H721007, H720682 ,H720747 ,H720808 ,H720861 ,H720908 ,H720958 ,H721008, H720683 ,H720748 ,H720809 ,H720862 ,H720909 ,H720959 ,H721009, H720684 ,H720749 ,H720810 ,H720863 ,H720910 ,H720960 ,H721010, H720686 ,H720750 ,H720811 ,H720864 ,H720911 ,H720961 ,H721011, H720688 ,H720752 ,H720812 ,H720865 ,H720913 ,H720962 ,H721012, H720689 ,H720754 ,H720813 ,H720866 ,H720914 ,H720963 ,H721013, H720692 ,H720756 ,H720814 ,H720867 ,H720915 ,H720964 ,H721014, H720693 ,H720759 ,H720815 ,H720868 ,H720916 ,H720965 ,H721015, H720694 ,H720760 ,H720816 ,H720869 ,H720918 ,H720966 ,H721016, H720697 ,H720761 ,H720817 ,H720870 ,H720919 ,H720967 ,H721017, H720699 ,H720763 ,H720818 ,H720871 ,H720920 ,H720968 ,H721018, H720701 ,H720766 ,H720819 ,H720872 ,H720921 ,H720969 ,H721019, H720702 ,H720767 ,H720820 ,H720873 ,H720922 ,H720974 ,H721020, H720704 ,H720769 ,H720822 ,H720874 ,H720923 ,H720975 ,H721022, H720705 ,H720770 ,H720823 ,H720875 ,H720925 ,H720976 ,H721023, H720706 ,H720773 ,H720824 ,H720876 ,H720926 ,H720977 ,H721024, H720707 ,H720774 ,H720825 ,H720877 ,H720927 ,H720978 ,H721025, H720711 ,H720775 ,H720826 ,H720878 ,H720928 ,H720979 ,H721026, H720712 ,H720776 ,H720827 ,H720879 ,H720929 ,H720980 ,H721027, H720714 ,H720777 ,H720829 ,H720880 ,H720930 ,H720981 ,H721028, H720715 ,H720778 ,H720830 ,H720881 ,H720931 ,H720982 ,H721029, H720716 ,H720780 ,H720831 ,H720882 ,H720932 ,H720983 ,H721030, H720718 ,H720781 ,H720832 ,H720883 ,H720933 ,H720984 ,H721031, H720719 ,H720782 ,H720833 ,H720884 ,H720935 ,H720985 ,H721032, H720720 ,H720783 ,H720834 ,H720885 ,H720936 ,H720986 ,H721033, H720721 ,H720784 ,H720835 ,H720886 ,H720937 ,H720987 ,H721034, H720722 ,H720786 ,H720836 ,H720888 ,H720938 ,H720988 ,H721035, H720723 ,H720787 ,H720840 ,H720889 ,H720940 ,H720989 ,H721036, H720724 ,H720788 ,H720841 ,H720890 ,H720941 ,H720990 ,H721037, H720725 ,H720790 ,H720842 ,H720891 ,H720942 ,H720991 ,H721038, H720726 ,H720792 ,H720843 ,H720892 ,H720943 ,H720992 ,H721039, H720727 ,H720795 ,H720844 ,H720894 ,H720945 ,H720993 ,H721040, H720728 ,H720796 ,H720847 ,H720895 ,H720946 ,H720995 ,H721041, H720729 ,H720797 ,H720848 ,H720896 ,H720947 ,H720996 ,H721042, H720732 ,H720798 ,H720849 ,H720897 ,H720948 ,H720997 ,H721043, H720733 ,H720799 ,H720851 ,H720898 ,H720949 ,H720998 ,H721044, H720734 ,H720800 ,H720852 ,H720899 ,H720950 ,H720999 ,H721045, H720737 ,H720801 ,H720854 ,H720901 ,H720951 ,H721000 ,H721046, H720739 ,H720802 ,H720855 ,H720902 ,H720952 ,H721001 ,H721047, H720741 ,H720803 ,H720856 ,H720903 ,H720953 ,H721002 ,H721048, H720742 ,H720804 ,H720857 ,H720904 ,H720954 ,H721004

510(k) numbers

["K853349","K964138"]

PMA numbers

not on file

Product code

not on file

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

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