SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
FDA Recall Z-2793-2026 · Posted 2026-07-23
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Recalling FirmAlphatec Spine, Inc.
Recall StatusOpen, Classified
Product CodeGWF
Date Initiated2026-05-13
Product Quantity3
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.
Firm 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.
Root Cause
Software Design Change
Distribution Pattern
US Nationwide distribution in the states of TX, MO, IN.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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