1488 1488020122Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327061161), received between May 27, 2022 and May 14, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Poor Quality Image” (5 reports).

3 other recalls cover devices cleared under the same FDA submission (K132785); they may or may not involve this specific model.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2025No Display/Image; Output Problem; Temperature Problem; No Display/Image; Output Problem; Temperature Problem

  IT WAS REPORTED THAT THE CAMERA STOPPED WORKING DURING THE PROCEDURE, THERE WAS A SMELL OF BURNED PLASTIC IN THE AIR. THEREFORE, THERE WAS A THERMAL EVENT AND LOSS OF IMAGE.

  Patient problems: Insufficient Information

  MAUDE report 22023325 ↗
• MalfunctionFeb 15, 2023Poor Visibility; Poor Visibility

  IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16382815 ↗
• MalfunctionFeb 9, 2023Poor Quality Image; Optical Distortion; Optical Distortion

  IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.

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

  MAUDE report 16336755 ↗
• MalfunctionFeb 9, 2023Poor Quality Image

  IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.

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

  MAUDE report 16335089 ↗
• MalfunctionFeb 8, 2023Poor Quality Image; Optical Problem; Optical Problem

  IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.

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

  MAUDE report 16326948 ↗
• MalfunctionFeb 8, 2023Poor Quality Image; Optical Problem; Optical Problem

  IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.

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

  MAUDE report 16326947 ↗
• MalfunctionJan 19, 2023Poor Quality Image; Poor Visibility; Poor Visibility

  IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.

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

  MAUDE report 16206367 ↗
• MalfunctionMay 27, 2022No Display/Image

  IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.

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

  MAUDE report 14522397 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132785. One submission often covers many models, so check the product and lot details in each record.

• Z-0569-2015 · Mar 5, 2013 · Terminated
  1488 HD 3-Chip Camera; Model Number 1488-210-105 - C-Mount. Product Usage: High definition camera to view endoscopic surgical sites on video monitors and capture still and video
• Z-0571-2015 · Mar 5, 2013 · Terminated
  1488 HD 3-Chip Camera; Model Number 1488-610-122 - HD 3-Chip Camera Head with Integrated Coupler. Product Usage: High definition camera to view endoscopic surgical sites on video
• Z-0570-2015 · Mar 5, 2013 · Terminated
  1488 HD 3-Chip Inline Camera; Model Number 1488-710-105 - HD 3-Chip Inline Camera, C-Mount; Product Usage: High definition camera to view endoscopic surgical sites on video monit