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.
Other recalls by Brainlab Ag
- Cirq Arm System 2.0
FDA Device · Class II · 2023-04-05 · Brainlab Ag - Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F
FDA Device · Class II · 2023-03-22 · Brainlab Ag - ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST
FDA Device · Class II · 2022-03-16 · Brainlab Ag - ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at…
FDA Device · Class II · 2021-06-16 · Brainlab Ag - ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System)
FDA Device · Class II · 2021-03-17 · Brainlab Ag
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1392-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.