Monaco Radiation Treatment Planning System — Class II medical device recall Z-0670-2020
Ongoing recall by Elekta Inc, reported 2019-12-18, distributed in IA, IN, NY, OH, TX, WI. Monaco is using the incorrect energy when optimizing and calculating dose.
| Recall number | Z-0670-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta Inc, Saint Charles, MO, United States |
| Recall initiated | 2019-11-22 |
| Classified | 2019-12-12 |
| Reported by FDA | 2019-12-18 |
| Distributed | IA, IN, NY, OH, TX, WI |
| Countries outside the US | AU, CA, CH, CN, DE, DK, GB, GR, HK, IT, NL, SE |
| UPC / GTIN / UDI-DI | 00858164002190, 00858164002244, 00858164002268 |
Product
Monaco Radiation Treatment Planning System (RTP) System
Reason for recall
Monaco is using the incorrect energy when optimizing and calculating 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-0670-2020. 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.