Reported Mar 26, 2025 · Ongoing

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

Brainlab AG

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Brainlab AG · Olof-Palme-Str. 9 · Munich, N/A · N/A

Is this the product you have?

  • Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
Lot codes and dates
  • Origin Data Management software version 3.1 is 04056481145118; Origin Data Management software version 3.2 is 04056481146078
Amount recalled
N/A

Where it was sold

  • Nationwide

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:56 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.