FDA Device recall Z-1233-2023
Monaco RTP System
- FDA Device
- Class II
- ongoing
- Published 2023-03-15
On 2023-03-15 the FDA classified a Class II recall of Monaco RTP System by Elekta, citing re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1233-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-02-28 |
| Published | 2023-03-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Elekta |
| Distribution | US |
Product
Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Reason
Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation.
Identifiers
| code_info | Software Build: 5.11.00, 5.11.01, 5.11.02, 5.11.03; UDI Numbers: (01)00858164002169(10)5.11.00, (01)00858164002169(1…Software Build: 5.11.00, 5.11.01, 5.11.02, 5.11.03; UDI Numbers: (01)00858164002169(10)5.11.00, (01)00858164002169(10)5.11.01, (01)00858164002169(10)5.11.02, (01)00858164002169(10)5.11.03 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1233-2023%22
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