FDA Device recall Z-1392-2025
Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
- FDA Device
- Class II
- ongoing
- Published 2025-03-26
On 2025-03-26 the FDA classified a Class II recall of Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1 by Brainlab Ag, citing under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without user notification.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1392-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-10 |
| Published | 2025-03-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Brainlab Ag |
| Distribution | US |
Product
Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
Reason
Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without user notification.
Identifiers
| code_info | Origin Data Management software version 3.1 is 04056481145118; Origin Data Management software version 3.2 is 04056481146078 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1392-2025%22
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