Class II — Brainlab AG
| Recalling firm | Brainlab Ltd. |
|---|---|
| Registered facility | Brainlab Ltd. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | When using a specific plan update workflow in combination with a non-Brainlab treatment planning system (TPS), there is a possibility in ExacTrac 5.5.5 to generate an unintended blend of two initially separate plans of the same patient. |
| Product | ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery. |
| Quantity | 40 systems (worldwide) |
| Distribution | Worldwide Distribution - US Nationwide in the states of AZ, AR, CA, FL, KY, MA, NE, NY, TN, TX and the countries of Argentina, Australia, Brazil, Finland, India, Japan, Netherlands, Oman, Russia, and Taiwan |
| Initiated | 2014-04-15 |
| Classified | 2014-06-03 |
| Terminated | 2017-04-24 |
| Recall number | Z-1707-2014 |
| 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-1707-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67926/
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