Plan Parameters workspace within Eclipse Treatment Planning System… — Class II medical device recall Z-0552-2014
Terminated recall by Varian Medical Systems, Inc., reported 2014-01-01. An anomaly has been traced to a software deficiency within the Plan Parameters workspace. When a dose relevant
| Recall number | Z-0552-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Varian Medical Systems, Inc., Palo Alto, CA, United States |
| Recall initiated | 2013-11-18 |
| Classified | 2013-12-20 |
| Reported by FDA | 2014-01-01 |
| Terminated | 2015-03-13 |
| Quantity | 6,701 |
| Reason classes | software |
| Model numbers | H48, H480001, H480002, H480003, H480004, H480009, H480010, H480011, H480016, H48001S, H480030, H480033, H480034, H480035, H480036, H480037, H480038, H480039, H480040, H480043, H480044, H48004S, H480051, H480052, H480053 and 475 more |
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.
Reason for recall
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.
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-0552-2014. 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.