Home / Recalls / Medical Devices
Brainlab AG recalls Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
Recalled March 26, 2025 · FDA recall Z-1392-2025 · Brainlab AG
Hazard
Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without user notification. · FDA Class II
Units
N/A
Sold at
Worldwide - US Nationwide distribution.
Description
Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without user notification.
Product
Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
Manufacturer(s)
Brainlab AG
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →