FDA Device recall Z-2409-2019
Monaco Radiation Treatment Planning System (RTP) System
- FDA Device
- Class II
- terminated
- Published 2019-09-04
On 2019-09-04 the FDA classified a Class II recall of Monaco Radiation Treatment Planning System (RTP) System by Elekta, citing monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setup Reference Report and is DICOM exporting incorrect (Anatomy/Beam) shift directions.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2409-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-08-23 |
| Published | 2019-09-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Elekta |
| Distribution | IN, OH |
Product
Monaco Radiation Treatment Planning System (RTP) System
Reason
Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setup Reference Report and is DICOM exporting incorrect (Anatomy/Beam) shift directions.
Identifiers
| code_info | Software Build: 5.50.00 & 5.51.00; UDI GTIN: (01)00858164002244(10) 5.50.00, (01)00858164002268(10) 5.51.00 |
|---|
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-2409-2019%22
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