[Recalled] Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00 — Under certain circumstances, there can be a difference between the planned and… | FDA 2021-10-13

The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.

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 →

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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.