C-MAC 8403HXRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551389447), received between May 30, 2025 and Jun 9, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Optical Problem” (2 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. 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.

• MalfunctionJun 9, 2025Use of Device Problem; Optical Problem; Use of Device Problem; Optical Problem

  ACCORDING TO THE INFORMATION RECEIVED, THE CUSTOMER HAS REPORTED IMAGE GOES DARK WHEN IN USE. ALSO THE COVER GLASS AT THE DISTAL WINDOW LOOKS TO BE MISSING. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22168182 ↗
• MalfunctionMay 30, 2025Optical Problem; Optical Problem

  ACCORDING TO THE INFORMATION RECEIVED, THE CUSTOMER HAS REPORTED IMAGE GOES DARK WHEN IN USE. ALSO, THE COVER GLASS AT THE DISTAL WINDOW LOOKS TO BE MISSING. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22115428 ↗