SafeOp Patient Interface — Class II medical device recall Z-2793-2026
Ongoing recall by Alphatec Spine, Inc., reported 2026-07-29, distributed nationwide. Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of trigger
| Recall number | Z-2793-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alphatec Spine, Inc., Carlsbad, CA, United States |
| Recall initiated | 2026-05-13 |
| Classified | 2026-07-23 |
| Reported by FDA | 2026-07-29 |
| Distributed | Nationwide (US) |
| Quantity | 3 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00190376517506 |
| Serial numbers | 2005490, 2005498, 2007716, DG106220, DG106225, DG106230 |
| Model numbers | AIX11240 |
Product
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2793-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.