Medical Device Recall: SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Alphatec Spine, Inc. · May 13, 2026
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.
Distribution
US Nationwide distribution in the states of TX, MO, IN.
States Affected
NATIONWIDE
Quantity Affected
3
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2793-2026
Status: ongoing
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