Events

Recall of Device Recall Eclipse V. 6.5

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
    48730
  • Event Risk Class
    Class 2
  • Event Number
    Z-2308-2008
  • Event Initiated Date
    2008-06-11
  • Event Date Posted
    2008-09-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72012
  • 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 was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Accelerator, Linear, Medical - Product Code IYE
  • Reason
    Software anomaly in which swapping ids of planning fields can produce inconsistencies between dose matrix and field parameters.
  • Action
    Recall initiated June 11, 2008 when the firm issued an Urgent Device Correction recall letter. The letter was distributed to all affected users, with problem description and user corrective action steps. If you have questions, contact your local Varian Customer Support Representative.

Device

Device Recall Eclipse V. 6.5
  • Model / Serial
    Product codes: H480001 H480341 H480738 H481107 H481548 H482157 H482608 H483158 H483809 H484524 H480003 H480345 H480740 H481108 H481553 H482158 H482609 H483159 H483818 H484535 H480004 H480348 H480749 H481114 H481554 H482159 H482611 H483161 H483820 H484539 H480009 H480351 H480753 H481115 H481556 H482160 H482624 H483164 H483821 H484540 H480012 H480355 H480754 H481116 H481558 H482162 H482625 H483180 H483823 H484544 H480017 H480356 H480756 H481133 H481559 H482163 H482630 H483181 H483830 H484553 H480019 H480357 H480762 H481135 H481567 H482166 H482634 H483191 H483835 H484603 H480022 H480358 H480764 H481141 H481571 H482173 H482638 H483207 H483840 H484610 H480025 H480367 H480766 H481142 H481572 H482178 H482641 H483224 H483843 H484617 H480026 H480371 H480773 H481143 H481573 H482179 H482645 H483244 H483847 H484634 H480030 H480373 H480775 H481163 H481585 H482189 H482648 H483253 H483852 H484639 H480032 H480375 H480776 H481180 H481588 H482198 H482662 H483254 H483858 H484640 H480040 H480382 H480779 H481195 H481597 H482199 H482664 H483255 H483869 H484641 H480042 H480385 H480781 H481196 H481599 H482203 H482671 H483270 H483915 H484643 H480043 H480404 H480794 H481197 H481601 H482204 H482681 H483275 H483916 H484650 H480049 H480411 H480798 H481198 H481602 H482205 H482683 H483277 H483942 H484657 H480050 H480416 H480810 H481205 H481605 H482215 H482691 H483312 H483943 H484658 H480056 H480417 H480814 H481206 H481607 H482225 H482697 H483315 H483970 H484673 H480063 H480418 H480816 H481213 H481609 H482228 H482698 H483317 H483973 H484677 H480067 H480420 H480817 H481226 H481618 H482243 H482704 H483322 H483975 H484680 H480068 H480421 H480820 H481229 H481625 H482244 H482709 H483325 H483984 H484681 H480072 H480432 H480821 H481232 H481627 H482247 H482714 H483328 H483987 H484684 H480073 H480443 H480827 H481239 H481631 H482256 H482715 H483341 H483988 H484695 H480075 H480445 H480830 H481250 H481632 H482264 H482726 H483345 H483991 H484698 H480078 H480455 H480833 H481252 H481641 H482273 H482762 H483355 H483994 H484699 H480095 H480458 H480839 H481257 H481647 H482274 H482763 H483356 H484002 H484706 H480102 H480459 H480852 H481259 H481661 H482283 H482770 H483363 H484003 H484744 H480104 H480461 H480855 H481262 H481678R1 H482284 H482773 H483370 H484010 H484752 H480105 H480462 H480861 H481279 H481681 H482285 H482791 H483371 H484015 H484757 H480108 H480464 H480868 H481285 H481692 H482286 H482796 H483373 H484024 H484770 H480109 H480470 H480873 H481286 H481696 H482288 H482799 H483381 H484031 H484781 H480116 H480478 H480876 H481289 H481698 H482292 H482801 H483384 H484049 H484788 H480117 H480483 H480886 H481294 H481702 H482295 H482803 H483396 H484052 H484839 H480123 H480485 H480891 H481297 H481711 H482327 H482815 H483410 H484053 H484844 H480128 H480486 H480893 H481299 H481715 H482369 H482817 H483424 H484057 H484846 H480129 H480488 H480894 H481312 H481716 H482372 H482818 H483427 H484077 H484856 H480131 H480496 H480896 H481315 H481717 H482374 H482824 H483431 H484083 H484861 H480138 H480500 H480897 H481318 H481718 H482380 H482826 H483434 H484085 H484864 H480140 H480510 H480906 H481319 H481724 H482381 H482832 H483449 H484087 H484873 H480141 H480513 H480907 H481326 H481727 H482389 H482835 H483453 H484099 H484910 H480142 H480530 H480908 H481330 H481748 H482390 H482842 H483459 H484105 H484911 H480151 H480533 H480916 H481334 H481751 H482401 H482844 H483463 H484121 H484912 H480152 H480535 H480923 H481338 H481754 H482403 H482849 H483465 H484124 H484960 H480172 H480536 H480927 H481340 H481758 H482408 H482853 H483466 H484128 H485041 H480174 H480537 H480930 H481341 H481765 H482411 H482856 H483477 H484135 H485053 H480183 H480539 H480933 H481344 H481767 H482418 H482865 H483495 H484144 H485079 H480185 H480542 H480937 H481345 H481768 H482420 H482870 H483496 H484149 H485083 H480186 H480543 H480945 H481352 H481770 H482436 H482871 H483500 H484155 H485113 H480190 H480547 H480946M H481357 H481771 H482438 H482876 H483506 H484160 H485114 H480199 H480549 H480946R1 H481358 H481791 H482439 H482882 H483509 H484161 H485135 H480200 H480554 H480951 H481361 H481797 H482440 H482888 H483525 H484163 H485183 H480201 H480573 H480953 H481364 H481800 H482442 H482890 H483531 H484170 H485188 H480207 H480577 H480958 H481374 H481802 H482448 H482897 H483532 H484174 H485209 H480211 H480587 H480961 H481376 H481803 H482450 H482915 H483535 H484175 H485219 H480212 H480588 H480963 H481377 H481810 H482456 H482921 H483538 H484177 H485268 H480217 H480589 H480964 H481378 H481818 H482460 H482926 H483555 H484180 H485269 H480219 H480596 H480967 H481384 H481824 H482461 H482928 H483557 H484185 H485271 H480220 H480599 H480968 H481389 H481825 H482473 H482941 H483558 H484221 H485276 H480222 H480601 H480970 H481391 H481834 H482484 H482946 H483587 H484228 H485279 H480233 H480606 H480971 H481393 H481837 H482485 H482964 H483591 H484254 H485288 H480238 H480608 H480973 H481401 H481840 H482487 H482982 H483592 H484257 H485311 H480239 H480611 H480974 H481406 H481849 H482489 H482988 H483595 H484258 H485333 H480244 H480615 H480976M H481420 H481857 H482492 H482989 H483602 H484269 H485365 H480245 H480617 H480976R1 H481421 H481859 H482493 H482992 H483606 H484274 H485371 H480247 H480619 H480983 H481423 H481861 H482502 H482993 H483615 H484277 H485389 H480248 H480622 H480985 H481426 H481862 H482506 H483001 H483616 H484280 H485399 H480250 H480626 H480989 H481429 H481880 H482508 H483002 H483619 H484286 H485430 H480265 H480639 H480992 H481431 H481881 H482519 H483010 H483632 H484287 H485453 H480266 H480645 H480993 H481432 H481892 H482520 H483012 H483639 H484321 H485457 H480278 H480651 H480994 H481435 H481893 H482521 H483024 H483646 H484324 H485471 H480281 H480653 H481006 H481436 H481896 H482522 H483028 H483647 H484333 H485520 H480283 H480657 H481011 H481442 H481897 H482531 H483029 H483650 H484337 H485547 H480286 H480658 H481014 H481446 H481900 H482539 H483040 H483654 H484340 H485558 H480289 H480659 H481022 H481448 H481901 H482540 H483042 H483670 H484347 H485569 H480295 H480661 H481041 H481467 H481910 H482544 H483057 H483675 H484348 H485592 H480301 H480662 H481043 H481475 H481911 H482545 H483063 H483679 H484351 H485596 H480305 H480671 H481054 H481486 H481918 H482556 H483088 H483686 H484367 H485628 H480307 H480691 H481058 H481487 H481921 H482561 H483091 H483688 H484371 H485658 H480309 H480692 H481060 H481489 H481927 H482562 H483095 H483690 H484374 H485684 H480311 H480694 H481062 H481493 H481936 H482564 H483103 H483691 H484375 H485692 H480316 H480698 H481063 H481494 H481939 H482566 H483106 H483697 H484383 H485693 H480319 H480702 H481066 H481503 H481940 H482571 H483115 H483706 H484386 H485695 H480321 H480704 H481070 H481504 H481952 H482572 H483117 H483717 H484388 H485696 H480323 H480714 H481071 H481507 H482114 H482578 H483123 H483749 H484421 H485719 H480329 H480717 H481074 H481513 H482120 H482586 H483134 H483750 H484437 H485721 H480333 H480718 H481077 H481515 H482121 H482587 H483138 H483751 H484467 H485846 H480336 H480722 H481079 H481526 H482124 H482590 H483143 H483755 H484476 H485853 H480340M H480726 H481088 H481530 H482125 H482593 H483151 H483757 H484497 H485943 H480340R1 H480727 H481104 H481535 H482129 H482594 H483153 H483767 H484509 H485995 H480732 H481106 H481544 H482151 H482603 H483154 H483803 H484513 H486114 H486135 H486209 H486214 H486250 H486403 H486434 H486657 and H486313
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed throughout the USA and to Argentina, Australia, Austria, Belgium, Byelorussia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, India, Israel, Iran, Italy, Ireland, Japan, Kozak, Latvia, Lebanon, Libya, Macau, Macedonia, Malaysia, Mexico, Morocco, New Zealand, Oman, Pakistan, Philippines, Poland, Portugal, Russian Fed., Saudi Arabia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, R.O.C., Thailand, The Netherlands, Turkey, Ukraine, United Kingdom, Venezuela, Vietnam.
  • Product Description
    Varian Medical Systems Eclipse device, model H48, Version 6.5 is used to plan photon and electron radiation therapy treatments.
  • 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