FDA recall Z-2793-2026

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.

Distribution

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

Key facts

Status

Ongoing

Initiation date

2026-05-13

Report date

2026-07-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Carlsbad, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2793-2026