Class II — Brainlab AG
| Recalling firm | Brainlab Ltd. |
|---|---|
| Registered facility | Brainlab Ltd. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | ExacTrac 6.x Patient Positioning System: Potentially incorrect patient positioning when using the ExacTrac Cone Beam CT (CBCT) with a CBCT acquired at a couch angle other than 0.0 degrees. |
| Product | ExacTrac 6.x. is software used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures. |
| Quantity | 25 systems (US only); 53 systems (Foreign) |
| Distribution | *** US: Nationwide; *** FOREIGN: Austria, China, Denmark, France, Germany, Hong Kong, Japan, Netherlands, Qatar, Russian Federation, South Korea, Switzerland |
| Initiated | 2015-03-06 |
| Classified | 2015-05-06 |
| Terminated | 2017-04-24 |
| Recall number | Z-1582-2015 |
| 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-1582-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70951/
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