Monaco RTP System — Class II medical device recall Z-2091-2019
Ongoing recall by Elekta Inc, reported 2019-08-07. When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, r
| Recall number | Z-2091-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta Inc, Maryland Heights, MO, United States |
| Recall initiated | 2019-07-03 |
| Classified | 2019-07-27 |
| Reported by FDA | 2019-08-07 |
| Quantity | 1,396 units |
Product
Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
Reason for recall
When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle, the Monitor Units are 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-2091-2019. 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.