FDA Device recall Z-2091-2019
Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
- FDA Device
- Class II
- ongoing
- Published 2019-08-07
On 2019-08-07 the FDA classified a Class II recall of Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System by Elekta, citing when creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle, the Monitor Units….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2091-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-07-03 |
| Published | 2019-08-07 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Elekta |
| Distribution | n/a |
Product
Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
Reason
When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle, the Monitor Units are scaled incorrectly.
Identifiers
| code_info | all Monaco Radiation Treatment Planning units installed with software version 5.10 or 5.11 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2091-2019%22
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