Oncentra Brachy radiation therapy planning system software — Class II medical device recall Z-0719-2023
Ongoing recall by Elekta, Inc., reported 2022-12-21, distributed nationwide. A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Impla
| Recall number | Z-0719-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2022-12-05 |
| Classified | 2022-12-15 |
| Reported by FDA | 2022-12-21 |
| Distributed | Nationwide (US) |
| Quantity | 336 systems |
| UPC / GTIN / UDI-DI | 08717213020610, 08717213038660, 08717213051294, 08717213051775, 08717213051782, 08717213051843, 08717213051881, 08717213052239, 08717213052246, 08717213052291, 08717213052307, 08717213052314, 08717213052321, 08717213052758, 08717213053700, 08717213053717 |
Product
Oncentra Brachy radiation therapy planning system software.
Reason for recall
A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0719-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.