SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Alphatec Spine, Inc.
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. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model 2005498/ DG106220Model 2005490/ DG106230UPC 00190376517506Would you have heard about this one?
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