FDA-Device2025-03-26Class II
Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
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.
Sold states
Worldwide - US Nationwide distribution.
Affected count
N/A
Manufactured in
Olof-Palme-Str. 9, N/A, Munich, N/A, Germany
Products
Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1392-2025Don't want to check this manually?
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