Monaco RTP System — Class II medical device recall Z-2406-2021
Ongoing recall by Elekta Inc, reported 2021-09-08, distributed in IA, NJ, NY, PA, TN, TX, WI. If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, i
| Recall number | Z-2406-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta Inc, Saint Charles, MO, United States |
| Recall initiated | 2021-07-26 |
| Classified | 2021-09-02 |
| Reported by FDA | 2021-09-08 |
| Distributed | IA, NJ, NY, PA, TN, TX, WI |
| Countries outside the US | AU, BE, BH, CA, CH, CN, DE, DK, ES, FR, GB, HK, IT, JP, KR, NL, SE, TH, TR |
| UPC / GTIN / UDI-DI | 00858164002190, 00858164002268 |
Product
Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10
Reason for recall
If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the couch unassigned to the beams.
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-2406-2021. 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.