FDA Device recall Z-2157-2013
DMLC IV-ERGO - Beam shaping block for Radiation Therapy
- FDA Device
- Class II
- terminated
- Published 2013-09-11
On 2013-09-11 the FDA classified a Class II recall of DMLC IV-ERGO - Beam shaping block for Radiation Therapy by Elekta, citing clinical mistreatment may occur when there are errors in the clinical workflow, or settings are incorrect.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2157-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-15 |
| Published | 2013-09-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Elekta |
| Distribution | US |
Product
DMLC IV-ERGO - Beam shaping block for Radiation Therapy.
Reason
Clinical mistreatment may occur when there are errors in the clinical workflow, or settings are incorrect.
Identifiers
| code_info | EM-042, EM7-004, EM-046, EM-060, EM-047, EM-029, EM7-003, EM7-002, EM7-008, EM-062, EM-063, EM3-004, 116001, 116012, 11…EM-042, EM7-004, EM-046, EM-060, EM-047, EM-029, EM7-003, EM7-002, EM7-008, EM-062, EM-063, EM3-004, 116001, 116012, 116044, 116055, 116014, 116052, 116023, 116056, 116053, 116043, 116047, 116051, 116122, 116068, 116013, 116046 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2157-2013%22
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