medical MODERATE Updated 2026-07-29

Alphatec Spine, Inc. recalls SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: N

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Recalled Product

SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System

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Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 00190376517506. System Set ID/Patient Interface Serial Number: 2007716/ DG106225, 2005498/ DG106220, 2005490/ DG106230

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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