Multileaf Collimator To be used for single or multiple fractions — Class II medical device recall Z-2340-2012
Terminated recall by Elekta, Inc., reported 2012-09-19, distributed nationwide. Information released with the product Agility did not originally contain information on compatibility with the
| Recall number | Z-2340-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Norcross, GA, United States |
| Recall initiated | 2012-07-27 |
| Classified | 2012-09-10 |
| Reported by FDA | 2012-09-19 |
| Terminated | 2014-10-06 |
| Distributed | Nationwide (US) |
| Quantity | 2 |
Product
Multileaf Collimator To be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.
Reason for recall
Information released with the product Agility did not originally contain information on compatibility with the add-on Dynamic Multileaf Collimator Apex.
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-2340-2012. 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.