Monaco RTP System — Class II medical device recall Z-2561-2019
Ongoing recall by Elekta Inc, reported 2019-10-02, distributed nationwide. It is possible that the forced electron density settings will be changed for some structures unintentionally a
| Recall number | Z-2561-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta Inc, Maryland Heights, MO, United States |
| Recall initiated | 2019-09-04 |
| Classified | 2019-09-25 |
| Reported by FDA | 2019-10-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CN, DE, DK, GB, GR, HK, IT, NL, SE |
| Quantity | 49 units |
| UPC / GTIN / UDI-DI | 00858164002244, 00858164002268 |
Product
Monaco RTP System, 5.50/5.51, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans and displays, on-screen and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for: -contouring -image manipulation -simulation -image fusion -plan optimization -QA and plan review
Reason for recall
It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.
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-2561-2019. 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.