4D Integrated Treatment Console
Medical device recall Z-2654-2014. Published in FDA’s Enforcement Report on Sep 24, 2014.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 24, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 512 affected devices how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
512 affected devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,994 characters
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…
FDA’s list runs to 4,130 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Aug 18, 2014.
- FDA classified it on Sep 16, 2014.
- FDA’s Enforcement Report published it on Sep 24, 2014.
- FDA terminated it on Jul 30, 2015.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Varian Medical Systems, Inc., of Palo Alto, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 4,130 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.