FDA Device recall Z-0978-2014
DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear accelerators to conform radiation dose delivery to geometrical vol…
- FDA Device
- Class II
- terminated
- Published 2014-03-05
On 2014-03-05 the FDA classified a Class II recall of DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear accelerators to conform radiation dose delivery to geometrical vol… by Elekta, citing it is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0978-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-05-01 |
| Published | 2014-03-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Elekta |
| Distribution | US |
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
It is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems
Identifiers
| code_info | Identifier : 116001, 116012, 116044, 116055, 116014, 116052, 116023, 116056, 116053, 116043, 116047, 116051, 116122, 116063, 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-0978-2014%22
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