Class II — Brainlab AG
| Recalling firm | Brainlab Ltd. |
|---|---|
| Registered facility | Brainlab Ltd. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5 |
| Product | ExacTrac Vero is a Patient Positioning System for Radiation therapy. |
| Quantity | 27 Systems |
| Distribution | Distributed in the states of Florida, New York, Texas and Ohio, and in the countries of Belgium, France, Germany, Italy, Japan and South Korea. |
| Initiated | 2016-05-04 |
| Classified | 2016-06-08 |
| Terminated | 2017-07-24 |
| Recall number | Z-1929-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Brainlab AG (Z-1929-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74265/
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