SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Summary
The FDA issued a Class II for SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix Sys by Alphatec Spine, Inc.. Reason: Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality.
Details
Source
Device Recall
External ID
Z-2793-2026
Action Date
2026-07-29
Status
Ongoing
Category
device
Product Description
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Lot/Code Info: UDI-DI: 00190376517506. System Set ID/Patient Interface Serial Number: 2007716/ DG106225, 2005498/ DG106220, 2005490/ DG106230
Quantity Affected: 3
Reason for 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.
Distribution
US Nationwide distribution in the states of TX, MO, IN.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-13
Company
Carlsbad, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 154 device recalls issued in the same week, part of 373 device-related FDA actions this month.
Alphatec Spine, Inc. has 40 FDA actions in our database, including 7 recalls and 33 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Alphatec Spine, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Alphatec Spine, Inc. have FDA actions?
Alphatec Spine, Inc. has 40 FDA actions in our database, including 7 recalls and 33 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2793-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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