Varian brand Varian Eclipse Treatment Planning System for radiotherapy — Class II medical device recall Z-2041-2012
Terminated recall by Varian Medical Systems, Inc. Oncology Systems, reported 2012-07-25, distributed nationwide. Varian has identified an anomaly with the Eclipse Treatment Planning (for radiotherapy treatments) where chang
| Recall number | Z-2041-2012 |
|---|---|
| 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 | 2012-06-18 |
| Classified | 2012-07-19 |
| Reported by FDA | 2012-07-25 |
| Terminated | 2014-08-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BH, BR, CA, CH, CL, CN, CO, DE, DK, EG, ES, FI, FR, GB, GR, HK, HU, ID, IE, IL, IN, IT, JP, KR, LV, MA, MX, MY, NL, NO, NP, PA, PL, PT, RO, SA, SE, SG, SK, TR, TW, UA, VE, ZA |
| Quantity | 7,113 units |
| Model numbers | H48 |
Product
Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model Number: H48; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA 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. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
Reason for recall
Varian has identified an anomaly with the Eclipse Treatment Planning (for radiotherapy treatments) where changing the prescription in a calculated VMAT or RapidArc plan may lead to Monitor Units which do not reflect the new prescription. If the dose prescription of a VMAT or RapidArc plan is changed after the initial Dose Volume Optimization, the Monitor Units and dose distribution may not reflect
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-2041-2012. 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.