Varian brand Eclipse Treatment Planning System — Class II medical device recall Z-2462-2012
Terminated recall by Varian Medical Systems, Inc. Oncology Systems, reported 2012-10-03, distributed nationwide. Varian has identified an anomaly with the Eclipse Treatment Planning where an outdated assigned Hounsfield Uni
| Recall number | Z-2462-2012 |
|---|---|
| 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 | 2012-08-17 |
| Classified | 2012-09-26 |
| Reported by FDA | 2012-10-03 |
| Terminated | 2014-08-06 |
| Distributed | Nationwide (US) |
| Quantity | 6,087 |
| Serial numbers | H480001, H480002, H480008, H480009, H480010, H480011, H480012, H480013, H480014, H480015, H480016, H480017, H480019, H480020, H480030, H480031, H480032, H480033, H480034, H480040, H480043, H480051, H480052, H480053, H480054 and 475 more |
| Model numbers | H48 |
Product
Varian brand Eclipse Treatment Planning System, Model Number: H48; Eclipse 8.9 and 10.0 Reference/FSCA Identifier: CP-08922; 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 algorithim is specifically indicated for planning proton treatment of neoplasms of the eyes.
Reason for recall
Varian has identified an anomaly with the Eclipse Treatment Planning where an outdated assigned Hounsfield Unit [HU] value can be used for dose calculation when the clock on the Eclipse Client Workstation is not synchronized with the Database/System Server. Treatment of the patient using these values can therefore lead to under or over-dose.
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-2462-2012. 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.