FDA Device recall Z-2793-2026
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
- FDA Device
- Class II
- ongoing
- Published 2026-07-29
On 2026-07-29 the FDA classified a Class II recall of SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System by Alphatec Spine, citing intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as sy….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2793-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-05-13 |
| Published | 2026-07-29 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Alphatec Spine |
| Distribution | US |
Product
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Reason
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.
Identifiers
| code_info | UDI-DI: 00190376517506. System Set ID/Patient Interface Serial Number: 2007716/ DG106225, 2005498/ DG106220, 2005490/ DG106230 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2793-2026%22
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