1588 AIM 1588610122Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613327174380), received between Feb 27, 2020 and Apr 10, 2024 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2024Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19084722 ↗
• MalfunctionJan 4, 2024Fogging; Fogging

  IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18449482 ↗
• MalfunctionNov 14, 2022Poor Quality Image

  IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15789933 ↗
• MalfunctionNov 8, 2022Display or Visual Feedback Problem; Output Problem; Output Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15754910 ↗
• MalfunctionOct 19, 2022No Display/Image; Optical Problem; Optical Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.

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

  MAUDE report 15631381 ↗
• MalfunctionMay 18, 2022No Display/Image; Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14429708 ↗
• MalfunctionAug 19, 2021Thermal Decomposition of Device; Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.

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

  MAUDE report 12345468 ↗
• InjuryApr 22, 2020Electrostatic Discharge; Electrostatic Discharge; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A USER WAS SHOCKED.

  Patient problems: Electric Shock

  MAUDE report 9986821 ↗
• MalfunctionMar 30, 2020Erratic or Intermittent Display; No Display/Image; Erratic or Intermittent Display

  IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE DURING A PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9899363 ↗
• MalfunctionFeb 27, 2020Erratic or Intermittent Display; Optical Distortion; Optical Distortion

  IT WAS REPORTED THAT THERE WAS A BLURRY IMAGE DURING A PROCEDURE. PLEASE NOTE, THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9765810 ↗
• MalfunctionFeb 27, 2020No Display/Image; Moisture Damage; Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE MOISTURE COULD NOT BE WIPED AWAY, RESULTING IN AN UNCLEAR IMAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9764288 ↗

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-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-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-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