1488 1488610122Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327061000), received between Jan 14, 2020 and May 15, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fogging” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2023Output Problem; Output Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16931076 ↗
• MalfunctionDec 21, 2022No Display/Image

  IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.

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

  MAUDE report 16030549 ↗
• MalfunctionMar 2, 2020Overheating of Device

  IT WAS REPORTED THAT THE CAMERA HEAD WAS OVERHEATING DURING A PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9777570 ↗
• MalfunctionJan 14, 2020Fogging; Poor Quality Image; Fogging

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9587430 ↗

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-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
• 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