Class II — Brainlab AG
| Recalling firm | Brainlab Ltd. |
|---|---|
| Registered facility | Brainlab Ltd. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Risk of mechanical instability due to potential manufacturing error of the device |
| Product | Cirq Arm System 2.0 |
| Quantity | 1 unit |
| Distribution | Texas |
| Initiated | 2023-03-02 |
| Classified | 2023-03-28 |
| Recall number | Z-1292-2023 |
| 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-1292-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91781/
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