Alphatec Spine SafeOp Patient Interface recalled for software-related nerve monitoring loss
The SafeOp Patient Interface (REF: AIX11240), part of the SafeOp 3 Neural Informatix System used during spine surgery, can lose or drop its nerve monitoring signal due to a software problem. When this happens, the device may show system errors, lose connection to the surgeon's tablet, and require a restart—potentially extending surgery time or changing the surgical plan.
From the FDA notice · Read the official notice ↗
What to do
- If you operate this device, contact Alphatec Spine, Inc. for a software update or further instructions.
- Do not use affected units until you receive guidance from the manufacturer.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
Details
- Units affected
- 3
- Illnesses reported
- None reported
- Manufactured in
- 1950 Camino Vida Roble, N/A, Carlsbad, CA, United States
- Classification
- Class II
- Recall number
- Z-2793-2026
In the FDA's words
- Description
- SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System 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. UDI-DI: 00190376517506. System Set ID/Patient Interface Serial Number: 2007716/ DG106225, 2005498/ DG106220, 2005490/ DG106230 Distribution: US Nationwide distribution in the states of TX, MO, IN. Affected quantity: 3
- 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.