Z-2793-2026Class II

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

Name: Z-2793-2026 SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Creator: Alphatec Spine, Inc.
Published: 2026-05-13
License: https://open.fda.gov/license/

Alphatec Spine, Inc. / initiated 2026-05-13 / Open, Classified / root cause: software

FDA source

Alphatec Spine, Inc. began a recall of SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System on 2026-05-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2793-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-13
Posted: 2026-07-23
Recalling firm: Alphatec Spine, Inc.
Product: SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Product code: GWF Stimulator, Electrical, Evoked Response
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.
Root cause tag: software
FDA root cause: Software Design Change
Action: On 5/13/2026, recall notices were emailed to customers who were advised of the following: 1) Recalling firm has provided replacement SafeOp 3 Systems. 2) Abstain from using affected devices and return to recalling firm. 3) Share this notice within your organization or any organization where the affected device(s) has(have) been transferred. 4) Fill out the last page of this letter to confirm that you have read this notification and have taken all necessary actions, as described in this notification. If you have any questions/concerns or require assistance with the recall, please e-mail [email protected] or call 1-800-922-1356.
Quantity in commerce: 3
Distribution: US Nationwide distribution in the states of TX, MO, IN.
Product codes and lots: UDI-DI: 00190376517506. System Set ID/Patient Interface Serial Number: 2007716/ DG106225, 2005498/ DG106220, 2005490/ DG106230

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2793-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2793-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-23

Product code GWF

K252842Class IISafeOp 3: Neural Informatix SystemAlphatec Spine, Inc. / cleared 2026-01-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)