NA 8404KXCRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04048551442159), received between May 20, 2025 and Sep 16, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Output below Specifications” (3 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Output below Specifications

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50796734 ↗
• MalfunctionAug 28, 2026Output below Specifications

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50508659 ↗
• MalfunctionJul 6, 2026Output below Specifications

  IT WAS REPORTED THAT A FLICKERING LIGHT AND NOT CONNECTING TO THE CMAC SCREEN. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25725351 ↗
• MalfunctionJun 30, 2026Image Display Error/Artifact

  THE FOLLOWING WAS REPORTED: "LIGHT IS TO DIM" NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25672891 ↗
• MalfunctionFeb 6, 2026Erratic or Intermittent Display

  IT WAS REPORTED THE VIDEO KEPT CUTTING IN AND OUT POWER WHILE IN US. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24278563 ↗
• MalfunctionSep 10, 2025Erratic or Intermittent Display; Display or Visual Feedback Problem; No Apparent Adverse Event; Erratic or Intermittent Display; Display or Visual Feedback Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT THE C-MAC VIDEO LARYNGOSCOPE HAS INTERMITTENT LOSS OF IMAGE WHEN CONNECTED TO THE MONITOR. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23019300 ↗
• MalfunctionAug 28, 2025Optical Problem; Optical Problem; No Apparent Adverse Event

  IT WAS REPORTED PRIOR TO A PROCEDURE THE BLADE IS CAUSING THE MONITOR TO LAG AND BLACK OUT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22914017 ↗
• MalfunctionJun 23, 2025No Display/Image; Use of Device Problem; No Display/Image; Use of Device Problem

  IT WAS REPORTED THAT THE IMAGE BLOCKS OUT. NO PATIENT OR PROCEDURE INVOLVEMENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22311178 ↗
• MalfunctionMay 20, 2025Poor Quality Image; Optical Problem; Poor Quality Image; Optical Problem

  IT WAS REPORTED THAT THE LIGHT SOURCE WAS DIM AND FAILING. NO PATIENT OR PROCEDURE INVOLVEMENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22053285 ↗