FDA Device recall Z-2561-2019
Monaco RTP System, 5.50/5.51, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for pati…
- FDA Device
- Class II
- ongoing
- Published 2019-10-02
On 2019-10-02 the FDA classified a Class II recall of Monaco RTP System, 5.50/5.51, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for pati… by Elekta, citing it is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2561-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-09-04 |
| Published | 2019-10-02 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Elekta |
| Distribution | US |
Product
Monaco RTP System, 5.50/5.51, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans and displays, on-screen and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for: -contouring -image manipulation -simulation -image fusion -plan optimization -QA and plan review
Reason
It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.
Identifiers
| code_info | UDI: (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: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2561-2019%22
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