FDA Device recall Z-0181-2016
Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam radiation therapy
- FDA Device
- Class II
- terminated
- Published 2015-11-04
On 2015-11-04 the FDA classified a Class II recall of Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam radiation therapy by Elekta, citing unintended update of Dose and MU and Incorrect Assignment of Bolus.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0181-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-16 |
| Published | 2015-11-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Elekta |
| Distribution | CA, IN, MI, MO, TX, WI |
Product
Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Reason
Unintended update of Dose and MU and Incorrect Assignment of Bolus.
Identifiers
| code_info | Software Version 5.10.01 |
|---|
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-0181-2016%22
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