Drug recall
Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
FDA recall event 96241 · Class II · Brainlab AG
Key facts
| Event ID | 96241 |
|---|---|
| Recall numbers | Z-1392-2025 |
| Recalling firm | Brainlab AG |
| Product type | Devices |
| Products | Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without user notification. |
| Initiation date | Feb 10, 2025 |
| Report date | Mar 26, 2025 |
| City | Munich |
| Country | Germany |
| FEI number | 3002619595 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: