Alphatec Spine, Inc. — Class II: SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Alphatec Spine, Inc. initiated a Class II recall for the SafeOp Patient Interface due to software issues that cause loss or interruption of triggered electromyography (tEMG) functionality. The failure presents as system faults, communication loss between the interface and tablet, or prompts requiring a system reboot.
Alphatec Spine, Inc., surgical teams using the SafeOp 3: Neural Informatix System, and clinical departments involved in intraoperative neuromonitoring.
Interruption of tEMG functionality during surgery may lead to increased operative time or unexpected changes to the surgical plan. This suggests a potential gap in software stability or communication protocols between the patient interface and the control tablet, necessitating a review of software-driven diagnostic reliability in the intraoperative setting.
Quality teams should review software validation protocols for intermittent communication failures between system components. Clinical operations teams must ensure surgical staff are trained on reboot procedures and contingency plans for intraoperative neuromonitoring interruptions to minimize surgical delays.
Class II. Reason: 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: SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System. Firm: Alphatec Spine, Inc. (Carlsbad CA United States). Status: Ongoing.
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