Elekta Monaco — Class II medical device recall Z-2563-2021
Ongoing recall by Elekta Inc, reported 2021-10-06, distributed nationwide. Contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dos
| Recall number | Z-2563-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta Inc, Saint Charles, MO, United States |
| Recall initiated | 2021-09-14 |
| Classified | 2021-09-24 |
| Reported by FDA | 2021-10-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BH, CA, CH, CN, DE, DK, ES, FR, GB, HK, IT, JP, KR, NL, SE, TH, TR |
| Quantity | 214 units |
| UPC / GTIN / UDI-DI | 00858164002190, 00858164002268 |
Product
Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Reason for recall
Contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to be frozen on the plans associated with that image set.
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-2563-2021. 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.