Monaco The Monaco system is used to make treatment plans for patients… — Class II medical device recall Z-2581-2014
Terminated recall by Elekta, Inc., reported 2014-09-10, distributed nationwide. Incorrect Delivery of Composite VMAT Fields - When DICOM is exporting an arc plan (VMAT, Dynamic Conformal or
| Recall number | Z-2581-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2014-08-18 |
| Classified | 2014-09-04 |
| Reported by FDA | 2014-09-10 |
| Terminated | 2021-09-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BH, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, IE, IL, IN, IQ, IT, JP, KR, LT, MA, MT, MX, MY, NL, NO, NZ, PE, PH, PK, PL, PT, RO, RU, SA, SE, SG, SI, TH, TR, TW, UA, ZA |
| Quantity | 928 units |
Product
Monaco The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in hard-copy, two or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups.
Reason for recall
Incorrect Delivery of Composite VMAT Fields - When DICOM is exporting an arc plan (VMAT, Dynamic Conformal or 3D Static Arcs) and using the Composite Field Sequencing (CFS) feature, the DICOM exported plan will not match the approved treatment plan.
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-2581-2014. 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.