Monaco Radiation Treatment Planning System — Class II medical device recall Z-2409-2019
Terminated recall by Elekta, Inc., reported 2019-09-04, distributed in IN, OH. Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setup Reference R
| Recall number | Z-2409-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2019-08-23 |
| Classified | 2019-08-27 |
| Reported by FDA | 2019-09-04 |
| Terminated | 2024-06-28 |
| Distributed | IN, OH |
| Countries outside the US | DE, GR, SE |
| Quantity | 49 units |
| UPC / GTIN / UDI-DI | 00858164002244, 00858164002268 |
Product
Monaco Radiation Treatment Planning System (RTP) System
Reason for recall
Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setup Reference Report and is DICOM exporting incorrect (Anatomy/Beam) shift directions.
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-2409-2019. 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.