FDA Device recall Z-1237-2015
Monaco radiation therapy treatment planning system
- FDA Device
- Class II
- terminated
- Published 2015-03-11
On 2015-03-11 the FDA classified a Class II recall of Monaco radiation therapy treatment planning system by Elekta, citing incorrect CT to ED when using the Monaco Image Statistics Tool.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1237-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-19 |
| Published | 2015-03-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Elekta |
| Distribution | US |
Product
Monaco radiation therapy treatment planning system. The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in hard-copy, two or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups.
Reason
Incorrect CT to ED when using the Monaco Image Statistics Tool.
Identifiers
| code_info | Monaco Release 3.30 and higher |
|---|
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-1237-2015%22
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