Z-0892-2011

Varian brand C-Series Ximatron Radiotherapy Treatment Stimulator, Model H72, Product is manufactured and...

Name: Z-0892-2011 Varian brand C-Series Ximatron Radiotherapy Treatment Stimulator, Model H72, Product is manufactured and...
Creator: Varian Medical Systems Oncology Systems
Published: 2010-01-19
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2010-01-19 / Terminated

FDA source

Varian Medical Systems Oncology Systems began a recall of Varian brand C-Series Ximatron Radiotherapy Treatment Stimulator, Model H72, Product is manufactured and distributed by Varian Oncology Systems, Palo Alto, CA... on 2010-01-19. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0892-2011
Status: Terminated
Initiated: 2010-01-19
Posted: 2011-01-11
Terminated: 2012-02-24
Recalling firm: Varian Medical Systems, Inc.
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.
Reason for recall: 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.
FDA 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.
Distribution: Worldwide Distribution including USA, Australia, New Zealand, Europe, Southeast Asia, China, Japan, Latin America, and Canada.
Product codes and lots: 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

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)