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Alphatec Spine, Inc.: SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System

Medical DevicesSource: FDA (device) · Date: 2026-07-29

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Alphatec Spine, Inc.
Product
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of TX, MO, IN.
Recall initiated
2026-05-13
Code info
UDI-DI: 00190376517506. System Set ID/Patient Interface Serial Number: 2007716/ DG106225, 2005498/ DG106220, 2005490/ DG106230
Product quantity
3
Voluntary mandated
Voluntary: Firm initiated
City
Carlsbad
State
CA
Country
United States
Event id
98967
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