C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy…
Medical device recall Z-0439-2014. Published in FDA’s Enforcement Report on Dec 11, 2013.
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 Dec 11, 2013. 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
- 3,809 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?
This correction is to notify users that a solution to a previous correction has been developed and Varians reps will be contacting locations to schedule installation.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
3,809 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model numbers Hl4, HIS, H27, H29: Serial numbers: H140001 H140136 H140700 H140759 Hl40817 H140875 Hl40937 H140995 Hl82047 H271330 H271664 H271935 H272132 H140011 Hl40137 H140701 H140760 Hl40818 H140876 Hl40938 H140996 Hl82048 H271334…
Every code shown here, 1,994 characters
Model numbers Hl4, HIS, H27, H29: Serial numbers: H140001 H140136 H140700 H140759 Hl40817 H140875 Hl40937 H140995 Hl82047 H271330 H271664 H271935 H272132 H140011 Hl40137 H140701 H140760 Hl40818 H140876 Hl40938 H140996 Hl82048 H271334 H271666 H271938 H272134 H140018 H140138 Hl40702 H140761 Hl40819 Hl40877 H140939 H140997 Hl82049 H271344 H271669 H271942 H272136 Hl40025 H140139 Hl40703 Hl40762 Hl40820 H140878 H140940 Hl40998 Hl82050 H271362 H271678 H271951 H272137 Hl40026 H140140 Hl40704 Hl40763 H140821 H140879 H140941 H140999 Hl820Sl H271370 H271681 H271954 H272138 Hl40027 Hl40141 Hl40705 Hl40764 H140822 Hl40880 H140942 Hl41000 Hl82054 H271378 H271691 H271958 H272143 H140029 H140142 Hl40706 Hl4076S H140823 H140881 H140943 Hl41001 Hl820SS H27138S H271693 H271959 H272144 Hl40036 H140143 Hl40707 Hl40766 H140824 H140882 H140944 H141002 H182056 H271393 H271711 H271961 H27214S H140038 H140144 H140708 H140767 H14082S H140883 H14094S H141003 Hl82057 H271398 H271712 H271964 H272146 H140039 H14014S H140709 H140768 H140826 H140884 H140946 H141004 Hl82058 H271407 H271713 H271966 H272150 H140043 H140146 H140710 H140769 H140827 H14088S H140947 H141005 Hl82060 H271413 H271714 H271972 H272153 Hl4004S H140147 H140711 H140770 Hl40828 H140886 H140948 H141007 H182061 H271414 H271724 H271973 H272155 Hl40046 H140148 H140712 H140771 H140829 H140888 H140949 H141009 H182062 H271420 H271729 H271974 H272156 H140047 H140150 H140713 H140772 H140830 H140889 H1409SO H141010 Hl82063 H271425 H271742 H271975 H272157 H140048 H140151 H140714 H140773 H140831 H140890 H140951 H141011 H182064 H271429 H271755 H271987 H272158 H140058 H140152 H140715 Hl40774 H140832 H140891 H140952 H141015 H182066 H271438 H271760 H271993 H272159 H140062 H140153 Hl40716 H140775 H140833 H140892 H140953 H141017 Hl82067 H271439 H271762 H271994 H272162 H140067 H140154 H140717 H140776 H140834 H140893 H140954 H141022 Hl82068 H271443 H271763 H272001 H272163 Hl40069 Hl40201 H140718 H140777 H140835 H140895 H140955 H182000 Hl82072…
FDA’s list runs to 30,515 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 in the countries of Algeria, Angola, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belgium, Belorussia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guam, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Uthuania, luxembourg, Macau, Macedonia, Malaysia, Martinique, Mauritania, Mexico, Moldova, Monaco, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, SriLanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Vietnam, and Zimbabwe.
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 Oct 24, 2013.
- FDA classified it on Dec 3, 2013.
- FDA’s Enforcement Report published it on Dec 11, 2013.
- FDA terminated it on Jan 13, 2016.
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 30,515 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.