SafeOp Patient Interface recall
Alphatec Spine, Inc. recalled SafeOp Patient Interface on July 29, 2026 because of 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. It was sold nationwide.
Why it was recalled
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.
What's recalled
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Quantity: 3
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Alphatec Spine, Inc., Carlsbad, CA
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
US Nationwide distribution in the states of TX, MO, IN. - Status
- Ongoing
- Recall number
- Z-2793-2026
- Source
- U.S. Food and Drug Administration
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