Events

Recall of 4D Integrated Treatment Console (4DITC), versions 10 and 11.

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

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
    69126
  • Event Risk Class
    Class 2
  • Event Number
    Z-2654-2014
  • Event Initiated Date
    2014-08-18
  • Event Date Posted
    2014-09-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129686
  • 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
    System,planning,radiation therapy treatment - Product Code MUJ
  • Reason
    Due to user error, the 4ditc can improperly allow users to clear a safety interlock imposed by the 4ditc on behalf of varian's bar code conical verification system from the brainlab's exactract console when it is used with bccv.
  • Action
    Varian issued an Urgent Medical Device Correction Notification letter dated August 19, 2014, to all affected sites. The letter informed users of the specific product and versions numbers as well as the issue. A list of third party systems that perform verification and communicate authorizations via ADI are included in Table 1 of the letter. The issue is only now to occur with the ExacTract positioning system in combination with a C-Series HE linac BCCV. User recommended actions are provided for users using auxiliary devices requiring ADI interface and for users performing SRS/SBRT. Varian has developed a fix for the issue and customer service representatives will be contacting all affected sites to schedule installation. A copy of the correction letter is to be kept with the most current labeling and all personnel who work in the radiotherapy department should be made aware of the content of the letter. The recall Return response form is to be completed and returned. Questions may be directed to 1-888-827-4265 for US and Canada. Contact information is also provided for other areas of the world.

Device

4D Integrated Treatment Console (4DITC), versions 10 and 11.
  • Model / Serial
    Model number H51; Serial numbers: H51B429 H514517 H511720 H514463 H511002 H513925 H514115 H510855 H515068 H514544 H512492 H515879 H515060 H513064 H514438 H514022 H512957 H514553 H515102 H515991 H515511 H51B421 H515106 H514189 H513551 H513009 H515033 H51B568 H515804 H51B611 H515004 H513477 H513133 H513562 H510966 H515691 H513894 H515363 H513801 H51B362 H518326 H518191 H514863 H513889 H514050 H515619 H515282 H515413 H51B240 H515815 H51B204 H512299 H513438 H51B233 H510451 H512146 H512507 H515601 H513692 H51B136 H51B479 H515247 H513069 H514278 H515588 H51B948 H514126 H512828 H513786 H515095 H513002 H515583 H51B100 H513891 H513591 H515657 H512829 H515800 H513300 H513249 H515249 H515819 H514365 H513127 H515064 H515849 H514464 H515998 H512287 H511424 H515561 H515454 H51B328 H51A050 H515727 H514433 H514282 H514186 H510889 H518106 H515031 H513826 H515251 H51B656 H512357 H514479 H512513 H51B585 H518138 H515947 H513772 H515336 H515759 H510340 H515231 H511399 H514336 H513353 H515446 H514609 H51B220 H515574 H514488 H513195 H515387 H514435 H512378 H514552 H51B154 H51B250 H513373 H512445 H512781 H510794 H510732 H512506 H513510 H512930 H51B331 H515393 H514101 H513054 H514382 H514160 H515323 H51B435 H51B781 H518526 H514599 H515259 H512464 H513152 H514102 H51B173 H515678 H513606 H51B098 H513354 H513081 H512613 H510408 H510004 H514313 H515681 H515521 H513307 H511012 H512785 H513517 H511275 H515115 H51B120 H513051 H51B725 H515317 H511551 H513545 H514192 H512134 H51B666 H513321 H512240 H511852 H514468 H510126 H512241 H513254 H511276 H514359 H511965 H512666 H515288 H51B733 H511703 H515718 H511607 H51B131 H511593 H512929 H514093 H51B769 H512938 H511675 H511840 H515943 H51B470 H513825 H51B083 H51A018 H514637 H51B537 H511748 H511865 H511983 H514662 H511691 H51B175 H515394 H515034 H515789 H513202 H515051 H513471 H515221 H515138 H514010 H51B034 H514600 H511964 H515346 H513554 H51B132 H515689 H511313 H515461 H51B153 H514649 H515874 H512433 H511878 H511330 H513117 H515182 H513769 H51B413 H51B868 H515966 H515298 H513700 H513298 H515262 H513273 H515295 H51B495 H515829 H512704 H514021 H513255 H511963 H518107 H513087 H510624 H51B393 H512090 H514523 H515767 H513713 H515620 H515467 H515126 H513527 H51B978 H514017 H51B517 H514632 H514001 H514184 H514332 H515984 H512980 H51B823 H515013 H51B959 H515656 H51B322 H511937 H513533 H514392 H51B060 H515737 H51B822 H515901 H513561 H513396 H512452 H510942 H511152 H511620 H51B251 H515509 H515492 H51B721 H510565 H513741 H514266 H515012 H51B509 H51B248 H514671 H515500 H514335 H515692 H515768 H514099 H513393 H51B011 H513793 H515501 H513460 H511683 H515299 H514439 H513275 H51B299 H515211 H51B873 H515531 H515878 H512993 H512278 H514080 H515835 H514669 H515169 H518178 H510915 H515941 H514417 H511915 H514402 H515524 H515039 H51B888 H51B724 H515181 H515587 H514357 H511466 H514403 H514212 H513553 H51B531 H51B595 H511303 H51B703 H512520 H513574 H511821 H513927 H515635 H51B546 H51B863 H515523 H51B190 H513906 H514621 H511699 H512992 H515191 H515171 H51B875 H515512 H513279 H512309 H514163 H514678 H515541 H515625 H515779 H515696 H514930 H512308 H513837 H514337 H513004 H512255 H514018 H51B197 H51B472 H51B520 H514424 H512022 H513080 H513770 H513957 H512454 H293495 H51B523 H513838 H51B079 H515104 H515304 H513972 H515361 H51B783 H513535 H515751 H514648 H51B726 H514628 H515329 H511663 H514059 H512642 H512024 H51B655 H515018 H515987 H515032 H51B363 H515897 H510866 H51B397 H515876 H51B816 H51B941 H512113 H513534 H512967 H513989 H514202 H513130 H51B891 H515931 H515448 H511746 H514504 H515434 H513125 H512253  H515703 H51B662 H514461 H513340 H513115 H514277 H516783 H512812  H51B871 H51B856 H515451 H514145 H512463 H511881 H516782 H513181  H513114 H51B285 H518379 H514069 H513095 H515071 H518109 H513888  H513276 H51B870 H515443 H513995 H515204 H512799 H51B557 H51B002  H513548 H51B768 H515499 H513648 H515044 H513262 H515011 H512618  H514158 H51B486 H514520 H513379 H515050 H513701 H515559 H515224 H514436 H51B390 H514521 H514394 H515017 H513456 H512744 H511971  H515356 H515739 H514615 H515105 H513381 H514379 H515764 H515780  H512527 H51B775 H514079 H512940 H512385 H515797 H51B055 H515486.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Brazil, Canada, Chili, China, Columbia, Czech Republic, France, Georgia, Germany, hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Macau, Malaysia, Mexico, Netherland,s Portugal, Qutar, Russia, Singapore, Slovenia, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Ukraine and United Kingdom.
  • Product Description
    4D Integrated Treatment Console (4DITC), versions 10 and 11. || 4DITC provided assistance for accurate treatment delivery by monitoring linear accelerator parameters and preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan.
  • Manufacturer
    Varian Medical Systems, Inc.

Manufacturer

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