All Elekta digital accelerators with electrons and beam modulator — Class II medical device recall Z-1065-2014
Terminated recall by Elekta, Inc., reported 2014-03-12, distributed nationwide. Customers are resetting the default values outside recommended factory settings.
| Recall number | Z-1065-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2013-05-28 |
| Classified | 2014-03-06 |
| Reported by FDA | 2014-03-12 |
| Terminated | 2021-09-15 |
| Distributed | Nationwide (US) |
| Quantity | 472 units |
Product
All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes
Reason for recall
Customers are resetting the default values outside recommended factory settings.
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-1065-2014. 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.