DMLC IV-ERGO Product Usage: Intended for use with rotating gantry… — Class II medical device recall Z-0978-2014
Terminated recall by Elekta, Inc., reported 2014-03-05, distributed nationwide. It is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems
| Recall number | Z-0978-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2013-05-01 |
| Classified | 2014-02-24 |
| Reported by FDA | 2014-03-05 |
| Terminated | 2015-01-29 |
| Distributed | Nationwide (US) |
| Quantity | 35 units |
Product
DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear accelerators to conform radiation dose delivery to geometrical volumes of specific shape containing pathology to be treated so that adjacent non-diseased tissues are spared to the extent possible.
Reason for recall
It is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems
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-0978-2014. 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.