FDA Device recall Z-1009-2017
Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy
- FDA Device
- Class II
- terminated
- Published 2017-01-18
On 2017-01-18 the FDA classified a Class II recall of Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy by Elekta, citing incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1009-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-21 |
| Published | 2017-01-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Elekta |
| Distribution | US |
Product
Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Reason
Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations.
Identifiers
| code_info | Software Versions 5.00 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-1009-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.