Monaco radiation therapy treatment planning system — Class II medical device recall Z-1237-2015
Terminated recall by Elekta, Inc., reported 2015-03-11, distributed nationwide. Incorrect CT to ED when using the Monaco Image Statistics Tool.
| Recall number | Z-1237-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2014-12-19 |
| Classified | 2015-03-02 |
| Reported by FDA | 2015-03-11 |
| Terminated | 2017-11-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DZ, EC, ES, FI, FR, GB, GR, HK, IE, IL, IN, IQ, IT, JO, JP, KR, LK, LT, MA, MT, MX, MY, NI, NL, NZ, PE, PH, PL, PT, RO, RU, SA, SE, SG, SI, TH, TR, TW, VE, ZA |
| Quantity | 1,354 |
Product
Monaco radiation therapy treatment planning system. 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 CT to ED when using the Monaco Image Statistics Tool.
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-1237-2015. 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.