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

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Agency
FDA
Record ID
Z-2793-2026
Canonical
https://claimwatch-mvp.vercel.app/item/alphatec-spine-inc-safeop-patient-interface-ref-aix11240-part-of-safeop-3-neural-informati/

What happened?

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

Who may be affected?

US Nationwide distribution in the states of TX, MO, IN.

What should consumers do?

Affected quantity: 3

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