FDA Device recall Z-1085-2014
Agility
- FDA Device
- Class II
- terminated
- Published 2014-03-12
On 2014-03-12 the FDA classified a Class II recall of Agility 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-1085-2014 |
| 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
Agility. Version 3.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.
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 3.1 |
|---|
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-1085-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.