C-MAC 8401BXCRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551002438), received between Mar 10, 2025 and Dec 10, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE VIDEO LARYNGOSCOPE MALFUNCTIONED DURING THE PROCEDURE. AFTER SEVERAL ATTEMPTS, FUNCTIONALITY WAS RESTORED. HOWEVER, THE IMAGE QUALITY REMAINED SIGNIFICANTLY COMPROMISED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771376 ↗
• MalfunctionMar 10, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE IMAGE TURNED OFF DURING THE PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21560947 ↗