Z-1392-2025 Class II Ongoing
FDA device recall Z-1392-2025 was initiated by Brainlab AG on February 10, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- March 26, 2025
- Initiation Date
- February 10, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
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 Pattern
Worldwide - US Nationwide distribution.
Code Information
Origin Data Management software version 3.1 is 04056481145118; Origin Data Management software version 3.2 is 04056481146078