Brainlab AG recalls Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1

Recall date

February 10, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1392-2025

FDA classification

Class II

Brand / firm

Brainlab AG

Sold / distributed

Worldwide - US Nationwide distribution.

Why it was recalled

Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without user notification.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1