C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100…
Medical device recall Z-2567-2014. 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
- 3416 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?
Trend in reports of unexpected decrease in beam output in C-series High Energy Linear Accelerators for 6MV photon treatment mode.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
3416, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model numbers HCX, H14, H27, H29. Serial numbers: H140001 H140152 H140724 H140791 H140857 H140924 H140985 H271272 H271729 H272009 H272180 H272353 H272819 H140011 H140201 H140725 H140792 H140858 H140925 H140986 H271276 H271755 H272014…
Every code shown here, 1,994 characters
Model numbers HCX, H14, H27, H29. Serial numbers: H140001 H140152 H140724 H140791 H140857 H140924 H140985 H271272 H271729 H272009 H272180 H272353 H272819 H140011 H140201 H140725 H140792 H140858 H140925 H140986 H271276 H271755 H272014 H272181 H272354 H272820 H140018 H140202 H140727 H140793 H140859 H140926 H140987 H271293 H271759 H272015 H272187 H272359 H272822 H140025 H140203 H140728 H140795 H140860 H140927 H140988 H271308 H271762 H272016 H272188 H272362 H272824 H140026 H140204 H140729 H140796 H140861 H140928 H140989 H271330 H271763 H272018 H272195 H272365 H272825 H140027 H140206 H140730 H140797 H140863 H140930 H140990 H271334 H271773 H272022 H272197 H272370 H272826 H140029 H140207 H140732 H140799 H140864 H140931 H140991 H271385 H271783 H272023 H272198 H272377 H272828 H140036 H140208 H140733 H140800 H140865 H140932 H140992 H271400 H271785 H272024 H272201 H272382 H272834 H140038 H140209 H140734 H140801 H140866 H140933 H140993 H271407 H271787 H272027 H272202 H272388 H272837 H140039 H140210 H140735 H140802 H140867 H140934 H140994 H271413 H271802 H272029 H272204 H272391 H272841 H140045 H140211 H140736 H140803 H140868 H140935 H140995 H271414 H271809 H272032 H272209 H272394 H272846 H140046 H140213 H140737 H140804 H140869 H140936 H140996 H271420 H271815 H272035 H272212 H272397 H272847 H140047 H140214 H140738 H140805 H140870 H140937 H140997 H271438 H271825 H272038 H272216 H272401 H272848 H140048 H140215 H140742 H140806 H140871 H140938 H140998 H271439 H271828 H272043 H272219 H272405 H272849 H140058 H140216 H140743 H140807 H140872 H140939 H140999 H271443 H271833 H272045 H272220 H272408 H272851 H140062 H140217 H140744 H140808 H140874 H140940 H141000 H271452 H271834 H272049 H272223 H272410 H272852 H140067 H140218 H140745 H140809 H140875 H140941 H141002 H271459 H271835 H272050 H272226 H272413 H272854 H140070 H140219 H140747 H140810 H140876 H140942 H141003 H271490 H271838 H272051 H272231 H272415 H272856 H140071 H140220 H140748 H140811 H140877 H140943 H141004 H271497 H271843…
FDA’s list runs to 27,593 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 the countries of Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Byelarus, Belgium, Bosniak, Brazil;, Bulgaria, Burma, Canada, Chile, China, Columbia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Germany, hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Luxembourg, Macau, Macedonia, Malaysia, Mauritania, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia,, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Venezuela.
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 Jun 17, 2014.
- FDA classified it on Sep 12, 2014.
- FDA’s Enforcement Report published it on Sep 24, 2014.
- FDA terminated it on Sep 20, 2018.
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 27,593 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
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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.