Integrity 3 — Class II medical device recall Z-1402-2013
Terminated recall by Elekta, Inc., reported 2013-06-05, distributed nationwide. Unexpected movement during beam delivery may not be detected if there are incorrect static tolerances for Lina
| Recall number | Z-1402-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2013-04-30 |
| Classified | 2013-05-24 |
| Reported by FDA | 2013-06-05 |
| Terminated | 2017-07-26 |
| Distributed | Nationwide (US) |
| Quantity | 31 |
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 for recall
Unexpected movement during beam delivery may not be detected if there are incorrect static tolerances for Linac Geometric Axes loaded in Integrity R3.0.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1402-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.