Lower riskMedical device recall · FDA · Published May 13, 2026
Alphatec SafeOp Patient Interface Software Issue May Cause System Faults
Alphatec recalls SafeOp Patient Interface (REF AIX11240) due to software issues that may cause system faults during surgery, potentially increasing operative time. Affected units have specific serial numbers.
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.
“Alphatec SafeOp Patient Interface Software Issue May Cause System Faults.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/127979-alphatec-safeop-patient-interface-software-issue-may-cause-system-faults. Based on FDA recall #Z-2793-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2793-2026%22&limit=1).
Alphatec Spine, Inc. voluntarily recalled the SafeOp Patient Interface (REF: AIX11240) due to a software issue that may cause loss of neuromonitoring functionality, according to the FDA on May 13, 2026.
How to tell if you have it
Brand: Alphatec
Product: SafeOp Patient Interface, part of SafeOp 3: Neural Informatix System
REF: AIX11240
UDI-DI: 00190376517506
Serial Numbers: DG106225 (System Set ID 2007716), DG106220 (System Set ID 2005498), DG106230 (System Set ID 2005490)
Quantity: 3 units
Distribution: Texas, Missouri, Indiana
The hazard
The device may experience loss or interruption of triggered electromyography (tEMG) functionality due to a software issue. This manifests as system faults, loss of communication between the Patient Interface and Tablet, and prompts requiring a system reboot, which may result in increased operative time and surgical plan changes.
Context
GovInfoNow's records show Alphatec Spine, Inc. has issued six other recalls since April 26, 2021. Recent brand recalls include the LIF NAV Osteotome 10mm on Jan. 2, 2026, and the Calibrate CCX Interbody System on Dec. 15, 2024. Other recent recalls of similar products include Medtronic Restore CP App Model A71100 Software Issue (Nov. 20, 2025), Howmedica Stryker CranialMask Tracker (Nov. 12, 2025), and GE HealthCare APEXPRO v5.0 Software Risk (April 24, 2026).
How to tell if you have this one
Check for the model reference AIX11240 on the device. Affected units have specific serial numbers: 2007716/DG106225, 2005498/DG106220, or 2005490/DG106230.
Brand
Alphatec
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Serial Number
Look for the serial numbers listed: 2007716/DG106225, 2005498/DG106220, or 2005490/DG106230.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 3 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of TX, MO, IN.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Indiana, Missouri, Texas.
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2793-2026 (May 13, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2793-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.