NA 26208AMARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04048551367537), received between May 27, 2026 and Sep 2, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Optical Distortion” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Poor Quality Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50570882 ↗
• MalfunctionAug 31, 2026Optical Distortion

  The following was reported: "The Vision is foggy, and there is a shadow due to a solder joint issue." No negative impact in state of health reported.

  Patient problems: Insufficient Information

  MAUDE report 50525011 ↗
• MalfunctionAug 27, 2026Optical Distortion

  The following was reported: "Telescope was found to be faulty and not clear. Image shows as if there is a fungus/water inside the field of view." No negative impact in state of health reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50479612 ↗
• MalfunctionMay 27, 2026Poor Quality Image

  IT WAS REPORTED "NOT CLEAR / BLUR". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25307045 ↗