Monaco RTP System Product Usage: The Monaco system is used to make… — Class II medical device recall Z-1879-2016
Terminated recall by Elekta, Inc., reported 2016-06-08, distributed nationwide. When DICOM exporting a 3D Monaco plan and the "Composite Field Sequencing" (CFS) checkbox is selected, the Y j
| Recall number | Z-1879-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2016-05-18 |
| Classified | 2016-06-02 |
| Reported by FDA | 2016-06-08 |
| Terminated | 2021-09-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BG, BR, CA, CH, CN, CY, CZ, DE, EC, EE, EG, ES, FR, GB, GR, HK, HR, ID, IL, IN, IR, IT, JP, KR, LK, LT, MA, MT, MX, MY, NL, NO, NZ, PA, PE, PL, PT, RS, RU, SE, SG, SK, TH, TR, UA, VE, ZA |
| Quantity | 1,401 units |
Product
Monaco RTP System Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Reason for recall
When DICOM exporting a 3D Monaco plan and the "Composite Field Sequencing" (CFS) checkbox is selected, the Y jaws will snap to the port shape when they should remain where they were defined.
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-1879-2016. 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.