FDA Device recall Z-1083-2014
Integrity
- FDA Device
- Class II
- terminated
- Published 2014-03-12
On 2014-03-12 the FDA classified a Class II recall of Integrity by Elekta, citing during the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1083-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-25 |
| Published | 2014-03-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Elekta |
| Distribution | US |
Product
Integrity. Version 1.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators.
Reason
During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.
Identifiers
| code_info | Model 1.1 |
|---|
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-1083-2014%22
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