FDA Device recall Z-0841-2013
Monaco RTP System
- FDA Device
- Class II
- terminated
- Published 2013-02-27
On 2013-02-27 the FDA classified a Class II recall of Monaco RTP System by Elekta, citing the beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" angle.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0841-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-11 |
| Published | 2013-02-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Elekta |
| Distribution | US |
Product
Monaco RTP System. Radiation treatment planning.
Reason
The beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" angle.
Identifiers
| code_info | Versions 3.20.00 and 3.20.01 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0841-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.