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Limited official informationFDA Medical Device Enforcement ReportsRecall date: Jul 29, 2026

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

Verification delayed

The last verified facts remain visible. Last successful verification: Aug 5, 2026, 7:44 AM UTC. A temporary source failure does not mean the recall changed.

Official information is incomplete

Missing: action. The page is public for lookup but excluded from search indexing and advertising.

1Is my item affected?

Compare the complete identifiers. Name similarity alone is not a confirmed match.

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

Identifiers to compare

  • UDI 00190376517506
  • Serial 2007716
Affected variants from the official event record
Product or modelCodes and lotsQuantityRecall number
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix SystemUDI-DI: 00190376517506. System Set ID/Patient Interface Serial Number: 2007716/ DG106225, 2005498/ DG106220, 2005490/ DG1062303Z-2793-2026

2What is the risk?

The agency's statement is shown without a site-authored severity score.

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.

Agency classification: Class II

3What should I do?

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

Verify on the official source

The linked agency record controls if any information differs.

Official evidence

Official scope

Distribution reported by the agency

US Nationwide distribution in the states of TX, MO, IN.

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

Material change history

No material affected-item, risk, action, or status change has been recorded since this page entered the tracker.