Monaco RTP System Used to make treatment plans for patients with… — Class II medical device recall Z-2712-2016
Terminated recall by Elekta, Inc., reported 2016-09-07, distributed in AK, AZ, CA, CO, CT, DC, FL, GA…. In a specific workflow where contours are edited (enlarged, moved, copied, etc.) and then the contour is delet
| Recall number | Z-2712-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2016-08-18 |
| Classified | 2016-09-01 |
| Reported by FDA | 2016-09-07 |
| Terminated | 2025-02-28 |
| Distributed | AK, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI |
| Countries outside the US | AR, AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CN, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KR, LK, LT, MA, MT, MX, MY, NI, NL, NO, NP, NZ, PA, PE, PH, PK, PL, PT, RO, RS, RU, SA, SE, SG, SI, SK, TH, TR, TW, UA, VE, VN, ZA |
| Quantity | 3,012 units |
Product
Monaco RTP System Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Reason for recall
In a specific workflow where contours are edited (enlarged, moved, copied, etc.) and then the contour is deleted on some slices and saved in the same session, it is possible that the deleted contours are still present which would not be the intent of the planner.
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-2712-2016. 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.