[Recalled] 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. — Unexpected movement during beam deliv
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| 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. |
|---|---|
| Brand / manufacturer | Elekta, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1402-2013 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 30 April 2013 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Unexpected movement during beam delivery may not be detected if there are incorrect static tolerances for Linac Geometric Axes loaded in Integrity R3.0.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Elekta, Inc.
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.
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