Monaco Radiation Treatment Planning System — Class II medical device recall Z-0112-2016
Terminated recall by Elekta, Inc., reported 2015-10-14, distributed in CA, IN, MI, MO, TX, WI. Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple prescriptions with
| Recall number | Z-0112-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2015-09-15 |
| Classified | 2015-10-07 |
| Reported by FDA | 2015-10-14 |
| Terminated | 2017-04-04 |
| Distributed | CA, IN, MI, MO, TX, WI |
| Countries outside the US | AU, CA, DE, GB, GR, IN, NL, NZ, TR |
| Quantity | 154 units |
Product
Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Reason for recall
Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple prescriptions with forced densities.
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-0112-2016. 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.