FDA Device recall Z-2712-2016
Monaco RTP System Used to make treatment plans for patients with prescriptions for external beam radiation therapy
- FDA Device
- Class II
- terminated
- Published 2016-09-07
On 2016-09-07 the FDA classified a Class II recall of Monaco RTP System Used to make treatment plans for patients with prescriptions for external beam radiation therapy by Elekta, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2712-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-08-18 |
| Published | 2016-09-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Elekta |
| Distribution | 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 |
Product
Monaco RTP System Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Reason
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.
Identifiers
| code_info | Software 3.1 and higher. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2712-2016%22
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