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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