Eclipse Treatment Planning System versions 11 — Class II medical device recall Z-0805-2016
Terminated recall by Varian Medical Systems, Inc., reported 2016-02-24, distributed nationwide. When using PBC 11.0.31 to calculate the dose for a conventional arc field with more than 100 segments for Ecli
| Recall number | Z-0805-2016 |
|---|---|
| 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 | 2016-01-11 |
| Classified | 2016-02-12 |
| Reported by FDA | 2016-02-24 |
| Terminated | 2017-10-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GH, GR, GT, HK, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JM, JP, KR, KW, LB, LT, LU, LV, MA, MT, MX, MY, NL, NO, NZ, PA, PE, PH, PK, PL, PT, PY, QA, RO, RU, SA, SE, SG, SK, SV, TH, TN, TR, TT, TW, UA, VE, VN, ZA |
| Quantity | 9,499 |
| Serial numbers | H480001, H480006, H480007, H480008, H480009, H480010, H480011, H480015, H480016, H480019, H480020, H480030, H480033, H480034, H480043, H480044, H480045, H480052, H480056, H480057, H480060, H480061, H480062, H480063, H480064 and 475 more |
| Model numbers | H48 |
Product
Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6; Model number: H48; Product Usage: 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
When using PBC 11.0.31 to calculate the dose for a conventional arc field with more than 100 segments for Eclipse versions 11.0, 13.0, 13.5 or 13.6, the displayed dose does not correspond to the calculated Monitor Units (MU). Potential for unintended radiation exposure.
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-0805-2016. 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.