Events

Recall of Device Recall Eclipse treatment planning system

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
    50496
  • Event Risk Class
    Class 2
  • Event Number
    Z-0861-2009
  • Event Initiated Date
    2008-11-21
  • Event Date Posted
    2009-02-20
  • 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=75523
  • 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
    linear accelerator treatment planning system - Product Code IYE
  • Reason
    Possible incorrect wedge orientation in treatment: software labeling was issued without warning message relating to preservation of user selected values for siemens wedge orientation, wedge limits and sad values for elekta machines, and collimator operating limits for saturne machines when the software version is upgraded.
  • Action
    An Urgent Device Correction product notification letter/field safetly letter dated November 21, 2008, was distributed to all affected users, with a description of the problem and user corrective action steps. The letter was also distributed to Varian Sales, Marketing and Service organizations, informing them of the issue.

Device

Device Recall Eclipse treatment planning system
  • Model / Serial
    Serial numbers H480002 H481912 H483369 H484526 H485316 H485593 H485859 H486079 H486328 H486602 H480005 H482181 H483429 H484532 H485334 H485594 H485862 H486086 H486330 H486606 H480016 H482186 H483471 H484587 H485338 H485603 H485867 H486089 H486331 H486613 H480092 H482192 H483485 H484593 H485340 H485615 H485871 H486092 H486332 H486617 H480112 H482194 H483488 H484635 H485342 H485629 H485873 H486094 H486336 H486618 H480114 H482250 H483560 H484661 H485345 H485632 H485874 H486097 H486338 H486629 H480132 H482270 H483566 H484663 H485347 H485633 H485875 H486108 H486342 H486633 H480169 H482294 H483570 H484692 H485352 H485642 H485883 H486120 H486346 H486639 H480293 H482324 H483586 H484709 H485359 H485646 H485901 H486121 H486348 H486641 H480294 H482427 H483715 H484763 H485362 H485648 H485912 H486123 H486349 H486642 H480300 H482462 H483724 H484767 H485363 H485656 H485913 H486127 H486356 H486653 H480427 H482523 H483731 H484791 H485370 H485668 H485918 H486128 H486369 H486665 H480433 H482528 H483756 H484813 H485374 H485669 H485926 H486130 H486385 H486667 H480446 H482541 H483764 H484838 H485375 H485670 H485933 H486132 H486411 H486680 H480467 H482557 H483769 H484841 H485380 H485671 H485934 H486134 H486412 H486685 H480481 H482579 H483797 H484847 H485382 H485672 H485936 H486136 H486440 H486686 H480514 H482677 H483799 H484857 H485388 H485676 H485941 H486138 H486444 H486689 H480570 H482678 H483800 H484866 H485391 H485681 H485946 H486140 H486445 H486694 H480583 H482699 H483808 H484875 H485393 H485694 H485947 H486143 H486451 H486700 H480670 H482706 H483827 H484876 H485414 H485699 H485948 H486188 H486452 H486701 H480723 H482710 H483879 H484950 H485421 H485701 H485949 H486198 H486457 H486703 H480759 H482722 H483921 H484954 H485433 H485703 H485953 H486202 H486473 H486707 H480780 H482725 H483937 H484970 H485437 H485709 H485963 H486205 H486474 H486708 H480789 H482727 H483964 H484975 H485441 H485715 H485964 H486206 H486481 H486715 H480809 H482761 H483980 H484977 H485443 H485717 H485966 H486207 H486488 H486717 H480822 H482769 H484013 H484979 H485447 H485739 H485967 H486223 H486490 H486721 H480889 H482821 H484103 H484988 H485449 H485749 H485971 H486224 H486498 H486724 H480890 H482848 H484186 H485014 H485454 H485751 H485972 H486228 H486500 H486756 H480996 H482892 H484200 H485024 H485463 H485753 H485981 H486230 H486501 H486758 H481003 H482920 H484235 H485026 H485468 H485771 H485983 H486233 H486503 H486759 H481154 H482934 H484250 H485035 H485472 H485776 H485987 H486236 H486509 H486766 H481165 H482970 H484256 H485039 H485475 H485778 H485988 H486247 H486520 H486793 H481193 H482997 H484263 H485043 H485477 H485789 H486003 H486257 H486522 H486803 H481203 H483060 H484283 H485081 H485485 H485794 H486008 H486260 H486525 H486804 H481215 H483070 H484294 H485098 H485488 H485795 H486010 H486271 H486531 H486805 H481220 H483086 H484308 H485129 H485489 H485798 H486016 H486273 H486541 H486806 H481296 H483109 H484311 H485136 H485491 H485802 H486023 H486276 H486543 H486809 H481308 H483146 H484317 H485143 H485517 H485804 H486024 H486278 H486549 H486820 H481309 H483176 H484323 H485148 H485519 H485805 H486025 H486288 H486550 H486826 H481445 H483178 H484332 H485165 H485533 H485806 H486029 H486289 H486555 H486831 H481497 H483182 H484336 H485193 H485537 H485812 H486032 H486292 H486556 H486840 H481551 H483200 H484346 H485236 H485538 H485815 H486034 H486294 H486558 H486848 H481562 H483203 H484377 H485240 H485541 H485816 H486038 H486295 H486561 H486856 H481667 H483210 H484419 H485243 H485543 H485820 H486040 H486298 H486566 H486866 H481685 H483243 H484430 H485291 H485545 H485823 H486046 H486299 H486567 H486871 H481737 H483248 H484439 H485292 H485546 H485827 H486058 H486300 H486570 H486872 H481744 H483273 H484450 H485297 H485550 H485828 H486062 H486301 H486579 H486875 H481787 H483279 H484472 H485301 H485551 H485831 H486066 H486313 H486589 H486893 H481835 H483321 H484475 H485308 H485556 H485834 H486067 H486316 H486592 H486899 H481870 H483327 H484506 H485309 H485564 H485844 H486072 H486317 H486597 H486902 H481906 H483329 H484510 H485310 H485568 H485850 H486075 H486327 H486600 H486907 H486908 H486914 H486924 H486949 H486973 H486975
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA, Austria, Belgium, Canada, Czech Republic, Finland, France, Germany, Greece, Hungary, Italy, Ireland, Lithuania, Norway, Portugal, Romania, Slovakia, Spain, Sweden, Switzerland, Netherlands, Turkey and the United Kingdom.
  • Product Description
    Varian Medical Systems Eclipse treatment planning system, Model Number H48, versions 6.5/7.x and Inspiration 8.0.
  • 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