FDA Device recall Z-2406-2021
Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10
- FDA Device
- Class II
- ongoing
- Published 2021-09-08
On 2021-09-08 the FDA classified a Class II recall of Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10 by Elekta, citing if a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the couch unassigned to the beams.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2406-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-07-26 |
| Published | 2021-09-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Elekta |
| Distribution | IA, NJ, NY, PA, TN, TX, WI |
Product
Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10
Reason
If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the couch unassigned to the beams.
Identifiers
| code_info | Software Builds: 5.40.00, 5.40.01, 5.40.02, 5.51.10 UDI: (01)00858164002190(10) 5.40.00 (01)00858164002190(10) 5.40.01…Software Builds: 5.40.00, 5.40.01, 5.40.02, 5.51.10 UDI: (01)00858164002190(10) 5.40.00 (01)00858164002190(10) 5.40.01 (01)00858164002190(10) 5.40.02 (01)00858164002268(10) 5.51.10 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2406-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.