Brainlab AG: Medical Device Recall in 2025 - (Recall #: Z-1392-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 10, 2025

Date Posted: March 26, 2025

Recall Number: Z-1392-2025

Event ID: 96241

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.

Status: Ongoing

Product Quantity: N/A

Code Information:

Origin Data Management software version 3.1 is 04056481145118; Origin Data Management software version 3.2 is 04056481146078

Distribution Pattern:

Worldwide - US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated