Class II — Brainlab AG
| Recalling firm | Brainlab Ltd. |
|---|---|
| Registered facility | Brainlab Ltd. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The usage of workflows that deviate from the recommended specifications in the User manual for ExacTrac Patient Positioning System (versions 6.0, 6.1, 6.2, 6.5) with Auxiliary Device Interface (ADI) and Varian Clinac or Varian TrueBeam, which may result in misinterpretation of beam authorization via ADI. |
| Product | ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment. |
| Quantity | 587 systems |
| Distribution | worldwide |
| Initiated | 2018-02-14 |
| Classified | 2018-03-14 |
| Terminated | 2021-05-17 |
| Recall number | Z-1006-2018 |
| 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-1006-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79266/
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