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FDAFebruary 10, 2025device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

brainlab agbrainlab

UPCs

0405648114511804056481146078

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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