Class II — Varian Medical Systems, Inc.
| 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 | 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. |
| Product | 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. |
| Quantity | 9499 |
| Distribution | 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… |
| Initiated | 2016-01-11 |
| Classified | 2016-02-12 |
| Terminated | 2017-10-25 |
| Recall number | Z-0805-2016 |
| 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. (Z-0805-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73092/
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