FDA Device recall Z-1044-2017
Monaco RTP System
- FDA Device
- Class II
- terminated
- Published 2017-01-25
On 2017-01-25 the FDA classified a Class II recall of Monaco RTP System by Elekta, citing incorrect dose after editing beam number an wedge angle.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1044-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-10 |
| Published | 2017-01-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Elekta |
| Distribution | AR, AZ, CA, CO, GA, IL, IN, LA, MA, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OR, PA, PR, SD, TX, UT, VA, WA, WI |
Product
Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Reason
Incorrect dose after editing beam number an wedge angle.
Identifiers
| code_info | Software Builds - V 5.10.00 (including 5.10.01, 5.10.02); V 5.11.00 (including 5.11.01); V 5.20.00 |
|---|
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-1044-2017%22
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