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Medical Device

SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System

Recall date: 2026-07-29 · Source: FDA_DEVICE
Brand / Firm
Alphatec Spine, Inc.
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.
Units affected
3
Description
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
View official recall notice →