Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6
Medical device recall Z-0805-2016. Published in FDA’s Enforcement Report on Feb 24, 2016.
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 Feb 24, 2016. 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
- 9499 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?
When using PBC 11.0.31 to calculate the dose for a conventional arc field with more than 100 segments for Eclipse versions 11.0, 13.0, 13.5 or 13.6, the displayed dose does not correspond to the calculated Monitor Units (MU). Potential for unintended radiation exposure.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6; Model number: H48; Product Usage: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments.
9499, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model: H48: Serial numbers: H480110 H48C045 H488552 H480119 H487642 H480345 H480409 H480541 H480814 H48D577 H481205 H48D125 H48I971 H488466 H48A830 H48G592 H48L819 H480267 H48C046 H488553 H480123 H48B153 H480348 H489828 H480542 H480819…
Every code shown here, 1,996 characters
Model: H48: Serial numbers: H480110 H48C045 H488552 H480119 H487642 H480345 H480409 H480541 H480814 H48D577 H481205 H48D125 H48I971 H488466 H48A830 H48G592 H48L819 H480267 H48C046 H488553 H480123 H48B153 H480348 H489828 H480542 H480819 H48D580 H481206 H48D126 H48I972 H489917 H48K547 H48G593 H48L823 H480268 H48K563 H48I901 H480124 H48B154 H480349 H48E077 H480566 H480820 H48I607 H481262 H48E255 H48I973 H48A912 H481952 H486308 H48J014 H482174 H48L882 H48I790 H480126 H48F494 H480350 H487078 H480590 H480821 H480981 H485005 H48F454 H481213 H48A913 H48C377 H486311 H48J017 H482934 H487080 H48I793 H480132 H48F495 H480357 H48D491 H480591 H480849 H480982 H485006 H48F864 H48L831 H48A914 H48C381 H48A679 H48J019 H484123 H487081 H48J346 H480133 H48F496 H480362 H480410 H480596 H480850 H48G047 H48F796 H48F974 H48L833 H48A915 H482311 H48K023 H481437 H486422 H487130 H48J354 H480137 H48F497 H480365 H480422 H480599 H480869 H481010 H484510 H48L347 H48H963 H48A916 H482312 H48K024 H481449 H486423 H487132 H48J355 H480822 H480189 H480371 H480423 H480600 H480883 H481011 H484511 H48L348 H48H964 H48A917 H482313 H48K025 H481451 H486653 H487133 H48J356 H480823 H480207 H480372 H480424 H480645 H480884 H481012 H48J026 H48L353 H481215 H48C365 H482314 H48K026 H481452 H486654 H487134 H485375 H480824 H480208 H480373 H480433 H480646 H480886 H481014 H48J027 H48L354 H481216 H48C366 H482315 H48K027 H481453 H48D648 H487135 H485376 H480825 H480209 H480374 H480434 H480647 H480887 H481015 H48F657 H48L355 H481217 H48E610 H482316 H48K028 H481454 H48D649 H487136 H485377 H48I594 H480219 H480378 H480438 H480651 H480894 H481016 H48F658 H48L356 H481234 H48E615 H482317 H481099 H481455 H48B995 H487137 H485378 H48I596 H480245 H480379 H480439 H480652 H480897 H481036 H48F659 H48L487 H481235 H48E616 H484880 H481100 H481456 H48B996 H486633 H48B178 H48I597 H480246 H480382 H480440 H480659 H480898 H481037 H48F660 H48L488 H481818 H48K780 H484881 H482730 H48J416 H48G455 H486634 H48B179 H48I599 H480247 H480384 H480446 H480665…
FDA’s list runs to 71,398 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 - US Nationwide and the countries of Albania, Guadeloupe, Norway,Algeria, Guam, Pakistan, Argentina, Guatemala, Panama,Australia, Hong Kong, Paraguay, Austria, Hungary, Peru,Azerbaijan, Iceland, Philippines, Bangladesh, India, Poland,Belgium, Indonesia ,Portugal, Belorussia, Iran, Puerto Rico,Brazil, Iraq, Qatar, Brunei Darussalam, Ireland, Reunion,Bulgaria, Israel, Romania, Burma, Italy, Russia,’Canada, Jamaica, Saudi Arabia, Chile, Japan, Singapore, China, Kazakhstan, Slovakia, Colombia, Kuwait, South Africa, Costa Rica, Latvia, South Korea,Czech Republic, Lebanon, Spain, Denmark, Libya, Sweden, Dominican Republic, Lithuania, Switzerland, Ecuador, Luxembourg, Taiwan, Egypt, Macau, Thailand, El Salvador, Macedonia, Trinidad and Tobago, Estonia, Madagascar, Tunisia, Finland, Malaysia, Turkey, France, Malta, Ukraine, French Polynesia, Mexico, United Arab Emirates, Georgia, Monaco, United Kingdom, Germany, Morocco, Venezuela, Ghana, Netherlands, Vietnam,Greece, New Zealand, 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 Jan 11, 2016.
- FDA classified it on Feb 12, 2016.
- FDA’s Enforcement Report published it on Feb 24, 2016.
- FDA terminated it on Oct 25, 2017.
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 71,398 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.