Events

Recall of Device Recall Varian brand CSeries Ximatron Radiotherapy Treatment Stimulator,

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Varian Medical Systems Oncology Systems.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    56350
  • Event Risk Class
    Class 2
  • Event Number
    Z-0892-2011
  • Event Initiated Date
    2010-01-19
  • Event Date Posted
    2011-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93282
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
  • 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.
  • 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.

Device

Device Recall Varian brand CSeries Ximatron Radiotherapy Treatment Stimulator,
  • Model / Serial
    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
  • Product Classification
    Radiology Devices
  • Distribution
    Worldwide Distribution including USA, Australia, New Zealand, Europe, Southeast Asia, China, Japan, Latin America, and Canada.
  • Product Description
    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.
  • Manufacturer
    Varian Medical Systems Oncology Systems

Manufacturer

Varian Medical Systems Oncology Systems
  • Manufacturer Address
    Varian Medical Systems Oncology Systems, 911 Hansen Way, Palo Alto CA 94304-1028
  • Manufacturer Parent Company (2017)
    Varian Medical Systems Inc
  • Source
    USFDA