Monaco TRP System The Monaco system is used to make treatment plans… — Class II medical device recall Z-0668-2017
Terminated recall by Elekta, Inc., reported 2016-12-07, distributed in AK, AZ, CA, CO, FL, GA, IL, IN…. Contours are not handled correctly if the CT dataset contains slices with DICOM Z coordinates of xx.x50mm.
| Recall number | Z-0668-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2016-11-17 |
| Classified | 2016-11-28 |
| Reported by FDA | 2016-12-07 |
| Terminated | 2021-12-17 |
| Distributed | AK, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, PR, SD, TX, UT, VA, WA, WI |
| Countries outside the US | AR, AT, AU, BG, BH, BR, CA, CH, CL, CN, CY, CZ, DE, DZ, EC, EE, EG, ES, FI, FR, GR, HK, HR, HU, ID, IL, IN, IQ, IR, IT, JP, KR, LK, LT, MA, MT, MX, MY, NL, NO, NP, NZ, PA, PE, PH, PL, PT, RO, RS, RU, SE, SG, SI, SK, TH, TN, TR, UA, VE, VN, ZA |
| Quantity | 2,148 |
Product
Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Reason for recall
Contours are not handled correctly if the CT dataset contains slices with DICOM Z coordinates of xx.x50mm.
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-0668-2017. 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.