Recall Z-1392-2025— Brainlab AG
Class II · Ongoing
Class II FDA medical device recall by Brainlab AG, initiated 2025-02-10. It names one FDA 510(k) clearance: K232759. Product: Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1. Reason: Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without user notification..
- Recalling firm
- Brainlab AG
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-02-10
- Firm location
- Munich, N/A, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.