FDA DeviceClass IINotable

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

Date: 2026-07-29
Brand: Alphatec Spine, Inc.
Category: Medical Device
FDA Class: Class II

Description

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.

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.

Remedy

3

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