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 | An anomaly has been traced to a software deficiency within the Plan Parameters workspace. When a dose relevant parameter is changed and "do no clear MUs and Reference Point dose" is selected, the Monitor units may change. |
| Product | Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiation Oncology versions 11 and 13 Acuity, versions 11 and 13. Manufactured by Varian Medical Systems Palo Alto, CA. Used in radiation therapy simulation. |
| Quantity | 6701 |
| Distribution | Worldwide Distribution. |
| Initiated | 2013-11-18 |
| Classified | 2013-12-20 |
| Terminated | 2015-03-13 |
| Recall number | Z-0552-2014 |
| 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-0552-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66956/
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