Monaco RTP System — Class II medical device recall Z-1233-2023
Ongoing recall by Elekta Inc, reported 2023-03-15, distributed nationwide. Re-optimization, after adding contours without forced density outside the external structure, may result in in
| Recall number | Z-1233-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta Inc, Saint Charles, MO, United States |
| Recall initiated | 2023-02-28 |
| Classified | 2023-03-07 |
| Reported by FDA | 2023-03-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CW, CY, CZ, DE, DZ, EC, EE, EG, ES, FI, FR, GB, GH, GR, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KR, LB, LK, LT, LV, MA, MT, MX, MY, NG, NI, NL, NO, NP, NZ, PA, PE, PH, PK, PL, PT, PY, RO, RS, SA, SE, SG, SI, SK, SV, TH, TN, TR, TW, UA, VE, VN, ZA |
| Quantity | 2,020 units |
| UPC / GTIN / UDI-DI | 00858164002169 |
Product
Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Reason for recall
Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation.
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-1233-2023. 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.