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 | The calculation of dose dynamic plans containing different energy fields is incorrect when the Pencil Beam Convolution 11.0 algorithm (PBC 11.0) is used. |
| Product | Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye. |
| Quantity | 1168 units |
| Distribution | Worldwide Distribution - USA Nationwide |
| Initiated | 2013-01-28 |
| Classified | 2013-02-20 |
| Terminated | 2014-04-04 |
| Recall number | Z-0867-2013 |
| 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-0867-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64319/
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