Origin Data Management software versions 3 — Class II medical device recall Z-1392-2025
Ongoing recall by Brainlab AG, reported 2025-03-26, distributed nationwide. Under certain circumstances, it can occur that patient records from unrelated individuals are automatically me
| Recall number | Z-1392-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Brainlab AG, Munich, N/A, Germany |
| Recall initiated | 2025-02-10 |
| Classified | 2025-03-18 |
| Reported by FDA | 2025-03-26 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 04056481145118, 04056481146078 |
Product
Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
Reason for recall
Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without user notification.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1392-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.