Recall
Alphatec Spine, Inc.: SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System 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. Product details: SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
What happened?
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. Product details: SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Who may be affected?
US Nationwide distribution in the states of TX, MO, IN.
What should consumers do?
Affected quantity: 3
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