FDA Device recall Z-0719-2023
Oncentra Brachy radiation therapy planning system software
- FDA Device
- Class II
- ongoing
- Published 2022-12-21
On 2022-12-21 the FDA classified a Class II recall of Oncentra Brachy radiation therapy planning system software by Elekta, citing A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0719-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-05 |
| Published | 2022-12-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Elekta |
| Distribution | US |
Product
Oncentra Brachy radiation therapy planning system software.
Reason
A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling
Identifiers
| code_info | Version 4.0 and above with Applicator Modeling or Implant Modeling; UDI GTIN numbers: 08717213052758, 08717213038660, 0…Version 4.0 and above with Applicator Modeling or Implant Modeling; UDI GTIN numbers: 08717213052758, 08717213038660, 08717213020610, 08717213052321, 08717213052314, 08717213052307, 08717213052291, 08717213052246, 08717213052239, 08717213051881, 08717213051843, 08717213051782, 08717213051775, 08717213051294, 08717213020610, 08717213053717, 08717213053700. |
|---|
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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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-0719-2023%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.