FDA Device recall Z-2563-2021
Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy
- FDA Device
- Class II
- ongoing
- Published 2021-10-06
On 2021-10-06 the FDA classified a Class II recall of Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy by Elekta, citing contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to be frozen on the plans associated with that image set.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2563-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-09-14 |
| Published | 2021-10-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Elekta |
| Distribution | US |
Product
Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Reason
Contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to be frozen on the plans associated with that image set.
Identifiers
| code_info | Software Builds: 5.40.00, 5.40.01, 5.40.02, 5.51.10; UDI GTIN: (01)00858164002190(10) 5.40.00, (01)00858164002190(10) 5…Software Builds: 5.40.00, 5.40.01, 5.40.02, 5.51.10; UDI GTIN: (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.
Other recalls by Elekta
- Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product Description: The Flet…
FDA Device · Class II · 2026-07-15 · Elekta - Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Description: The intended use of the Advanced…
FDA Device · Class II · 2026-07-15 · Elekta - Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description: The device is intended for intracavitary brachytherapy for c…
FDA Device · Class II · 2026-07-15 · Elekta - MOSAIQ Oncology Information System
FDA Device · Class II · 2026-06-17 · Elekta - Brand Name: Leksell Vantage Arc System REF: 1053958
FDA Device · Class II · 2026-05-06 · Elekta
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2563-2021%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.