Class II — Varian Medical Systems, Inc. Oncology Systems
| Recalling firm | Varian Medical Systems, Inc |
|---|---|
| Registered facility | View this company's 14 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Varian has identified an anomaly with the Eclipse Treatment Planning (for radiotherapy treatments) where changing the prescription in a calculated VMAT or RapidArc plan may lead to Monitor Units which do not reflect the new prescription. If the dose prescription of a VMAT or RapidArc plan is changed after the initial Dose Volume Optimization, the Monitor Units and dose distribution may not reflect |
| Product | Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model Number: H48; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA 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. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of th… |
| Quantity | 7113 units |
| Distribution | Worldwide distribution: USA (nationwide) and countries including of: Austria, Australia, Bahrain, Belgium, Brazil, Canada, China, Chile, Colombia, Denmark, Egypt, Finland, France,Germany, Greece, Hungary, Hong Kong, India, Indonesia, Israel, Ireland, Italy, Japan, Latvia, Malaysia, Mexico, Morocco, Nepal, Netherlands, Norway, Panama, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Singapore,… |
| Initiated | 2012-06-18 |
| Classified | 2012-07-19 |
| Terminated | 2014-08-06 |
| Recall number | Z-2041-2012 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Varian Medical Systems, Inc. Oncology Systems (Z-2041-2012).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/62420/
Alerts for Varian Medical Systems, Inc
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.