Monaco RTP System Product Usage: Used to make treatment plans for… — Class II medical device recall Z-1009-2017
Terminated recall by Elekta, Inc., reported 2017-01-18, distributed nationwide. Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations.
| Recall number | Z-1009-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2016-12-21 |
| Classified | 2017-01-11 |
| Reported by FDA | 2017-01-18 |
| Terminated | 2021-07-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CA, CN, DE, EE, ES, HR, IN, JP, NL, NO, NZ, PL, RS, RU, TR, ZA |
| Quantity | 279 |
Product
Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Reason for recall
Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations.
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-1009-2017. 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.