Varian Eclipse Treatment Planning System for Radiotherapy — Class II medical device recall Z-0867-2013
Terminated recall by Varian Medical Systems, Inc. Oncology Systems, reported 2013-02-27, distributed nationwide. The calculation of dose dynamic plans containing different energy fields is incorrect when the Pencil Beam Con
| Recall number | Z-0867-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, United States |
| Recall initiated | 2013-01-28 |
| Classified | 2013-02-20 |
| Reported by FDA | 2013-02-27 |
| Terminated | 2014-04-04 |
| Distributed | Nationwide (US) |
| Quantity | 1,168 units |
| Reason classes | software |
| Model numbers | H48 |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0867-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.