medical Class II Updated 2025-03-26

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

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Origin Data Management software version 3.1 is 04056481145118; Origin Data Management software version 3.2 is 04056481146078
View official government recall

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