Oncentra External Beam 4 — Class II medical device recall Z-0118-2013
Terminated recall by Elekta, Inc., reported 2012-10-31, distributed nationwide. During the planning process the beam weights can be changed by the customers. When the beam weights are change
| Recall number | Z-0118-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Norcross, GA, United States |
| Recall initiated | 2012-08-21 |
| Classified | 2012-10-23 |
| Reported by FDA | 2012-10-31 |
| Terminated | 2014-11-03 |
| Distributed | Nationwide (US) |
| Quantity | 52 units |
Product
Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension for the purpose of treating patients with cancer.
Reason for recall
During the planning process the beam weights can be changed by the customers. When the beam weights are changed and renumbered and this happens during the dose calculation it is possible to save and reopen the plan without any error messages.
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-0118-2013. 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.