FDA Device recall Z-0660-2017
Monaco RTP System
- FDA Device
- Class II
- terminated
- Published 2016-12-07
On 2016-12-07 the FDA classified a Class II recall of Monaco RTP System by Elekta, citing incorrect Dose when using the reset function.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0660-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-03 |
| Published | 2016-12-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Elekta |
| Distribution | AK, AZ, CA, CO, FL, GA, IL, IN, MA, MI, MN, MO, NC, NH, NV, NY, OH, OK, OR, PA, SD, TX, UT, VA, WA, WI |
Product
Monaco RTP System; Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Reason
Incorrect Dose when using the reset function.
Identifiers
| code_info | Software Builds 5.11 and 5.20 |
|---|
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-0660-2017%22
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