Class II — Elekta, Inc.
| Recalling firm | ELEKTA AB |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Clinical mistreatment may occur when there are errors in the clinical workflow, or settings are incorrect. |
| Product | DMLC IV-ERGO - Beam shaping block for Radiation Therapy. |
| Quantity | 31 |
| Distribution | Nationwide distribution: AL, CT, FL, GA, IA, MS, MO, NJ, NY, ND, OH, OK, PA, RI, TX, VA and Puerto Rico. |
| Initiated | 2013-08-15 |
| Classified | 2013-09-04 |
| Terminated | 2015-07-28 |
| Recall number | Z-2157-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Elekta, Inc. (Z-2157-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66048/
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