FDA Device recall Z-0670-2020
Monaco Radiation Treatment Planning System (RTP) System
- FDA Device
- Class II
- ongoing
- Published 2019-12-18
On 2019-12-18 the FDA classified a Class II recall of Monaco Radiation Treatment Planning System (RTP) System by Elekta, citing monaco is using the incorrect energy when optimizing and calculating dose.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0670-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-11-22 |
| Published | 2019-12-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Elekta |
| Distribution | IA, IN, NY, OH, TX, WI |
Product
Monaco Radiation Treatment Planning System (RTP) System
Reason
Monaco is using the incorrect energy when optimizing and calculating dose.
Identifiers
| code_info | Software Builds: 5.40.00, 5.50.00 and 5.51.00. UDI GTIN: (01)00858164002190(10) 5.40.00, (01)00858164002244(10) 5…Software Builds: 5.40.00, 5.50.00 and 5.51.00. UDI GTIN: (01)00858164002190(10) 5.40.00, (01)00858164002244(10) 5.50.00, and (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.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0670-2020%22
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