FDA Device recall Z-0112-2016
Monaco Radiation Treatment Planning System
- FDA Device
- Class II
- terminated
- Published 2015-10-14
On 2015-10-14 the FDA classified a Class II recall of Monaco Radiation Treatment Planning System by Elekta, citing dose and MU are incorrect when CT images are viewed from the head, and, when using multiple prescriptions with forced densities.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0112-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-15 |
| Published | 2015-10-14 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Elekta |
| Distribution | CA, IN, MI, MO, TX, WI |
Product
Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Reason
Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple prescriptions with forced densities.
Identifiers
| code_info | Software Version 5.10.00 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0112-2016%22
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