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

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.

Details from the source

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. Quantity: 3 Lot/code info: UDI-DI: 00190376517506. System Set ID/Patient Interface Serial Number: 2007716/ DG106225, 2005498/ DG106220, 2005490/ DG106230

UPC codes

00190376517506

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.