Recall archive / FDA device enforcement
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System — FDA record Z-2793-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 13, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Alphatec Spine, Inc.
- Quantity
- 3
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2793-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 00190376517506. System Set ID/Patient Interface Serial Number: 2007716/ DG106225, 2005498/ DG106220, 2005490/ DG106230 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution in the states of TX, MO, IN.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jul 29, 2026
- Recall initiation date
- May 13, 2026
- Center classification date
- Jul 23, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.