Elekta MONACO RTP Sytem — Class II medical device recall Z-1825-2020
Ongoing recall by Elekta Inc, reported 2020-05-06, distributed nationwide. The Monaco RTP Radiation Treatment Planning System may change the shape and volume of the contour potentially
| Recall number | Z-1825-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta Inc, Saint Charles, MO, United States |
| Recall initiated | 2020-04-16 |
| Classified | 2020-04-29 |
| Reported by FDA | 2020-05-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CH, CN, DE, DK, GB, HK, IT, NL, SE, TH, TR |
| Quantity | 96 devices |
| UPC / GTIN / UDI-DI | 00858164002190 |
Product
Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The
Reason for recall
The Monaco RTP Radiation Treatment Planning System may change the shape and volume of the contour potentially resulting in the device delivering an inaccurate 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-1825-2020. 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.