Device product
Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
Z-1392-2025
Product summary
- Firm
- Brainlab AG
- Event
- Event 96241
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1392-2025
Official wording
Reason: Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without user notification.
Code information: Origin Data Management software version 3.1 is 04056481145118; Origin Data Management software version 3.2 is 04056481146078
Distribution pattern: Worldwide - US Nationwide distribution.
Derived failure modes
-
Unknown
Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without user notification.