Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
Reported: March 26, 2025 Initiated: February 10, 2025 #Z-1392-2025
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.
Details
- Recalling Firm
- Brainlab AG
- Units Affected
- N/A
- Distribution
- Worldwide - US Nationwide distribution.
- Location
- Munich, N/A
Frequently Asked Questions
What product was recalled? ▼
Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1. Recalled by Brainlab AG. Units affected: N/A.
Why was this product recalled? ▼
Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without user notification.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 26, 2025. Severity: Moderate. Recall number: Z-1392-2025.
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