United StatesSafeOp Patient Interface, REF AIX11240, part of the SafeOp 3: Neural Informatix System (UDI‑DI 00190376517506; System Set ID/Patient Interface serials 2007716/DG106225, 2005498/DG106220, 2005490/DG106230) sold nationwide in TX, MO and IN (3 units) is affected. A software issue may cause loss or interruption of triggered electromyography (tEMG) functionality, display system faults, loss of communication between the Patient Interface and Tablet, and prompts requiring system reboot, which may increase operative time and lead to surgical plan change.
What's being recalled
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Recalling firm: Alphatec Spine, Inc., Carlsbad, CA, United States.
How to identify it
UDI-DI: 00190376517506. System Set ID/Patient Interface Serial Number: 2007716/ DG106225, 2005498/ DG106220, 2005490/ DG106230
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of TX, MO, IN.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)