DMLC IV-ERGO — Class II medical device recall Z-2157-2013
Terminated recall by Elekta, Inc., reported 2013-09-11, distributed nationwide. Clinical mistreatment may occur when there are errors in the clinical workflow, or settings are incorrect.
| Recall number | Z-2157-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2013-08-15 |
| Classified | 2013-09-04 |
| Reported by FDA | 2013-09-11 |
| Terminated | 2015-07-28 |
| Distributed | Nationwide (US) |
| Quantity | 31 |
Product
DMLC IV-ERGO - Beam shaping block for Radiation Therapy.
Reason for recall
Clinical mistreatment may occur when there are errors in the clinical workflow, or settings are incorrect.
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-2157-2013. 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.