TemporaryFDAOngoing
Can cause harm that is usually temporary.
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Check the device or its packaging for
UDI-DI: 00190376517506. System Set ID/Patient Interface Serial Number: 2007716/ DG106225, 2005498/ DG106220, 2005490/ DG106230
- Why
- 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.
- Distributed
- US Nationwide distribution in the states of TX, MO, IN.
- Company
- Alphatec Spine, Inc.
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-2793-2026 · retrieved 23 July 2026
Read the official notice