NA C12916Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05415067006127), received between Mar 30, 2026 and Mar 30, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Communication or Transmission Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Communication or Transmission Problem

  DURING A DIAGNOSTIC PROCEDURE, THERE WAS AO DRIFT. THE ISSUE WAS FOUND TO BE CAUSED BY THE WI-BOX AND ADAPTER AND MONITOR CABLES. THE PROCEDURE WAS ABANDONED, BUT THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24709185 ↗