Alphatec Spine, Inc. — SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
⚠️ Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication between the Patient Interface and Tablet, and prompts requiring system reboot; may result in increased operative time and surgical plan change.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- May 13, 2026
US Nationwide distribution in the states of TX, MO, IN.
What's affected?
- Product
- SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
- Brand
- Alphatec Spine, Inc.
- Lot code
- UDI-DI: 00190376517506. System Set ID/Patient Interface Serial Number: 2007716/ DG106225, 2005498/ DG106220, 2005490/ DG106230
Additional details
UDI-DI: 00190376517506. System Set ID/Patient Interface Serial Number: 2007716/ DG106225, 2005498/ DG106220, 2005490/ DG106230
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 3.
Get Health recall alerts
Delivered to your inbox. Free. No account required.