FDA Device recall Z-1879-2016
Monaco RTP System Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiat…
- FDA Device
- Class II
- terminated
- Published 2016-06-08
On 2016-06-08 the FDA classified a Class II recall of Monaco RTP System Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiat… by Elekta, citing when DICOM exporting a 3D Monaco plan and the "Composite Field Sequencing" (CFS) checkbox is selected, the Y jaws will snap to the port shape when they should remain where they we….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1879-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-18 |
| Published | 2016-06-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Elekta |
| Distribution | US |
Product
Monaco RTP System Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Reason
When DICOM exporting a 3D Monaco plan and the "Composite Field Sequencing" (CFS) checkbox is selected, the Y jaws will snap to the port shape when they should remain where they were defined.
Identifiers
| code_info | Monaco versions 5.10.00 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-1879-2016%22
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