# FDA recall Z-1392-2025

> **Brainlab AG** · Class II · device recall initiated 2025-02-10.

## Product

Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1

## 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.

## Distribution

Worldwide - US Nationwide distribution.

## Key facts

- **Recall number:** Z-1392-2025
- **Recalling firm:** Brainlab AG
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-02-10
- **Report date:** 2025-03-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Munich, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1392-2025

## Citation

> AI Analytics. FDA recall Z-1392-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1392-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*