Brainlab AG: Device Recall
Recall #Z-1392-2025 · 02/10/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1392-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Brainlab AG
- Status
- Ongoing
- Date Initiated
- 02/10/2025
- Location
- Munich, N/A, Germany
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
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.
Product Description
Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
Distribution Pattern
Worldwide - US Nationwide distribution.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.