FDA Device recall Z-1402-2013
Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming th…
- FDA Device
- Class II
- terminated
- Published 2013-06-05
On 2013-06-05 the FDA classified a Class II recall of Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming th… by Elekta, citing unexpected movement during beam delivery may not be detected if there are incorrect static tolerances for Linac Geometric Axes loaded in Integrity R3.0.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1402-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-30 |
| Published | 2013-06-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Elekta |
| Distribution | US |
Product
Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.
Reason
Unexpected movement during beam delivery may not be detected if there are incorrect static tolerances for Linac Geometric Axes loaded in Integrity R3.0.
Identifiers
| code_info | 325134, 325254, 325082, 325159, 325268, 325237, 325331, 325267, 325236, 325314, 325127, 325261, 325286, 325077, 325269,…325134, 325254, 325082, 325159, 325268, 325237, 325331, 325267, 325236, 325314, 325127, 325261, 325286, 325077, 325269, 325129, 325296, 325273, 325139, 325201, 325137, 325184, 325161, 325076, 325086, 325112, 325081, 325083, 325099, 325110, 325271 |
|---|
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-1402-2013%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.