FDA Medical devices recall ·
Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1 recall
- Recall number
- Z-1392-2025
- Date
- (initiated February 10, 2025)
- Company / brand
- Brainlab AG
Olof-Palme-Str. 9, Munich, N/A, Germany - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- N/A
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
Why was it recalled?
Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without user notification.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Origin Data Management software version 3.1 is 04056481145118; Origin Data Management software version 3.2 is 04056481146078
Distribution
Worldwide - US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1392-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.