Monaco RTP System The Monaco system is used to make treatment plans… — Class II medical device recall Z-0076-2017
Terminated recall by Elekta, Inc., reported 2016-10-19, distributed in CA, FL, KY, MD, MO, MT, NC, NJ…. When creating 3D plans using either MU or Dose weighting modes, if the user changes the Physician's Intent Rx
| Recall number | Z-0076-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2016-09-29 |
| Classified | 2016-10-13 |
| Reported by FDA | 2016-10-19 |
| Terminated | 2021-07-16 |
| Distributed | CA, FL, KY, MD, MO, MT, NC, NJ, PA, WA, WI |
| Countries outside the US | AR, AT, AU, BG, BR, CN, CZ, DE, DZ, EC, EE, ES, FR, GB, HR, IL, IN, IR, IT, JP, KR, LK, MA, MX, MY, NL, NO, NZ, PA, PE, PH, PT, RO, RU, SI, SK, TH, TR, UA, VE, ZA |
| Quantity | 365 |
Product
Monaco RTP 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 treatment plans and displays, on-screen and in hard-copy, two or three dimensional radiation dose distribution inside patients for given treatment plan set-ups
Reason for recall
When creating 3D plans using either MU or Dose weighting modes, if the user changes the Physician's Intent Rx Dose and/or the number of fractions, and then modifies the wedge angle, the MU value is scaled incorrectly.
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-0076-2017. 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.