Monaco RTP System — Class II medical device recall Z-0841-2013
Terminated recall by Elekta, Inc., reported 2013-02-27, distributed nationwide. The beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" angle.
| Recall number | Z-0841-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2013-02-11 |
| Classified | 2013-02-20 |
| Reported by FDA | 2013-02-27 |
| Terminated | 2014-01-21 |
| Distributed | Nationwide (US) |
| Quantity | 13 |
Product
Monaco RTP System. Radiation treatment planning.
Reason for recall
The beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" angle.
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-0841-2013. 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.