Monaco Radiation Treatment Planning — Class II medical device recall Z-0965-2019
Terminated recall by Elekta, Inc., reported 2019-03-06, distributed in TX, WI. If Improve Target Dose was chosen as an optimization model in a previous treatment session, Monaco¿ will autom
| Recall number | Z-0965-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2019-02-08 |
| Classified | 2019-02-27 |
| Reported by FDA | 2019-03-06 |
| Terminated | 2024-08-19 |
| Distributed | TX, WI |
| Countries outside the US | DE, DK, GB, NL, SE |
| Quantity | 14 devices |
Product
Monaco Radiation Treatment Planning (RTP) System
Reason for recall
If Improve Target Dose was chosen as an optimization model in a previous treatment session, Monaco¿ will automatically use this optimization model again when proceeding with the online plan adaptation of a completion plan when it should not.
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-0965-2019. 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.