Class II — Brainlab AG
| Recalling firm | Brainlab Ltd. |
|---|---|
| Registered facility | Brainlab Ltd. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without user notification. |
| Product | Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1 |
| Quantity | N/A |
| Distribution | Worldwide - US Nationwide distribution. |
| Initiated | 2025-02-10 |
| Classified | 2025-03-18 |
| Recall number | Z-1392-2025 |
| 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-1392-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96241/
Alerts for Brainlab Ltd.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.