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.
- Agency
- FDA Device
- Recall date
- May 13, 2026
- Status
- Ongoing
- Company
- Alphatec Spine, Inc.
1. What product was recalled?
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Quantity: 3
Code or lot text: UDI-DI: 00190376517506. System Set ID/Patient Interface Serial Number: 2007716/ DG106225, 2005498/ DG106220, 2005490/ DG106230
- LOT
- 2005490/ DG106230
- LOT
- 2005498/ DG106220
- LOT
- UDI-DI: 00190376517506. System Set ID/Patient Interface Serial Number: 2007716/ DG106225
- RECALL-NUMBER
- Z-2793-2026
2. Is my exact product affected?
Compare every printed identifier. A matching value can indicate that your product is included.
3. What is the 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.
4. What should I do now?
Follow the FDA recall notice and contact the recalling company for current instructions.
5. Where was it sold or distributed?
Nationwide
View source evidence for state distribution
- Indiana: US Nationwide distribution in the states of TX, MO, IN.
- Missouri: US Nationwide distribution in the states of TX, MO, IN.
- Texas: US Nationwide distribution in the states of TX, MO, IN.
6. Were injuries or illnesses reported?
No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.
7. What remedy is available?
Follow the FDA recall notice and contact the recalling company for current instructions.
8. Is the recall active or closed?
The source status is Ongoing. Recall Index urgency is elevated, which is a separate deterministic site label.
9. When was the information checked?
Last checked .
- created
10. Where is the official source?
Open the official FDA Device source
Recall Index normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.