Official recall notice
FDA Recall: SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
- Recall date
- 2026-07-29
- Brand
- Alphatec Spine, Inc.
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
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.
Product description
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.
Affected products
UDI-DI: 00190376517506. System Set ID/Patient Interface Serial Number: 2007716/ DG106225, 2005498/ DG106220, 2005490/ DG106230