Eclipse Treatment Planning System version 13 — Class II medical device recall Z-0990-2017
Terminated recall by Varian Medical Systems, Inc., reported 2017-01-18, distributed in FL, NJ, OR, TN. Modifications in version 13.6MR2 for Contouring, SmartAdapt, and SmartSegmentation workspaces resulted in cont
| Recall number | Z-0990-2017 |
|---|---|
| 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 | 2016-12-02 |
| Classified | 2017-01-10 |
| Reported by FDA | 2017-01-18 |
| Terminated | 2017-05-12 |
| Distributed | FL, NJ, OR, TN |
| Quantity | 42 devices |
| Serial numbers | H480113, H480118, H481195, H481236, H481237, H481884, H481885, H481886, H481916, H481917, H482484, H484198, H484199, H487302, H488949, H48A587, H48A680, H48A871, H48A872, H48A873, H48A874, H48A875, H48A876, H48A877, H48A878 and 17 more |
| Model numbers | H48 |
Product
Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmentation Knowledge Based Contouring version 2.3 [2.3.12] Radiology: 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.
Reason for recall
Modifications in version 13.6MR2 for Contouring, SmartAdapt, and SmartSegmentation workspaces resulted in contours not being saved consistently in Eclipse. Treatment Planning System. The issue only occurs if certain conditions are fulfilled.
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-0990-2017. 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.