Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Origin Data Management software versions 3.1.0 Recalled by Brainlab AG Due to Under certain circumstances, it can occur that patient...

Date: February 10, 2025
Company: Brainlab AG
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Brainlab AG directly.

Affected Products

Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1

Quantity: N/A

Why Was This Recalled?

Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without user notification.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Brainlab AG

Brainlab AG has 39 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report