1288 1288020122Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327063417), received between Dec 12, 2019 and Jun 30, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fogging” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2022No Display/Image; Loss of Data; Loss of Data

  IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.

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

  MAUDE report 14878486 ↗
• MalfunctionFeb 17, 2022Fogging; Fogging

  IT WAS REPORTED THAT THERE WAS A POTENTIAL OF ADVERSE CONSEQUENCES DUE TO FOGGING.

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

  MAUDE report 13551721 ↗
• MalfunctionDec 12, 2019Fogging; Fogging

  IT WAS REPORTED THAT THERE WAS FOGGING DURING A PROCEDURE, WHICH COULD NOT BE WIPED AWAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9459358 ↗

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