Alphatec Spine SafeOp Patient Interface recalled for software-related nerve monitoring loss
What this means
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.
- 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.
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2793-2026Want us to check the next one for you?
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