FDA Device recall Z-0668-2017
Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy
- FDA Device
- Class II
- terminated
- Published 2016-12-07
On 2016-12-07 the FDA classified a Class II recall of Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy by Elekta, citing contours are not handled correctly if the CT dataset contains slices with DICOM Z coordinates of xx.x50mm.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0668-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-17 |
| Published | 2016-12-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Elekta |
| Distribution | 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 |
Product
Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Reason
Contours are not handled correctly if the CT dataset contains slices with DICOM Z coordinates of xx.x50mm.
Identifiers
| code_info | Software Builds 5.00 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-0668-2017%22
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