FDA recall Z-1392-2025

Brainlab AG · Class II · device

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.

Distribution

Worldwide - US Nationwide distribution.

Key facts

Status: Ongoing
Initiation date: 2025-02-10
Report date: 2025-03-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: Munich, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1392-2025