Alphatec Spine, Inc.: Stimulator, Electrical, Evoked Response

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.

Tags

FDA recall, medical device, class 2, Neurology, Software Design Change, Open, Classified

Related exam domains

CISSP 3: Security Architecture and Engineering; CISSP 7: Security Operations; CISSP 8: Software Development Security; CISM 4: Incident Management

Source record id

Z-2793-2026

First seen by InfoSec Signals

Sep 23, 2026

Source: openFDA device recalls, U.S. Food and Drug Administration · about this source · more from it

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