FDA Device recall Z-0965-2019
Monaco Radiation Treatment Planning (RTP) System
- FDA Device
- Class II
- terminated
- Published 2019-03-06
On 2019-03-06 the FDA classified a Class II recall of Monaco Radiation Treatment Planning (RTP) System by Elekta, citing if Improve Target Dose was chosen as an optimization model in a previous treatment session, Monaco¿ will automatically use this optimization model again when proceeding with the o….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0965-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-02-08 |
| Published | 2019-03-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Elekta |
| Distribution | TX, WI |
Product
Monaco Radiation Treatment Planning (RTP) System
Reason
If Improve Target Dose was chosen as an optimization model in a previous treatment session, Monaco¿ will automatically use this optimization model again when proceeding with the online plan adaptation of a completion plan when it should not.
Identifiers
| code_info | Software version 5.40 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0965-2019%22
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