VIDEO COLONOSCOPE EC-3490LIRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04961333232253), received between Dec 16, 2021 and Dec 16, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “No Display/Image” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K131855); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2021No Display/Image; No Display/Image

  A CUSTOMER REPORTED THAT THERE WAS DARK IMAGING ON THE SCREEN OF A EC-3490LI- VIDEO COLONOSCOPE. THE TIMING AND LOCATION OF THE OBSERVATION ARE UNKNOWN AT THIS TIME. THERE WERE NO PATIENT OR USER INJURIES, ADVERSE EVENTS, DELAY, OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13023410 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131855. One submission often covers many models, so check the product and lot details in each record.

• Z-2448-2021 · Jul 14, 2021 · Open, Classified
  Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC
• Z-2449-2021 · Jul 14, 2021 · Open, Classified
  Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10; Gastroscope Family # 2- Gastroscopes with a Water Jet Chan
• Z-1267-2020 · Jan 3, 2020 · Terminated
  Pentax Video Colonoscope Model: EC34-i10L
• Z-1268-2020 · Jan 3, 2020 · Terminated
  Pentax Video Colonoscope Model: EC38-i10L
• Z-0636-2017 · Aug 15, 2016 · Terminated
  Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including light source), documentation equipment, Monitor, EndoTherapy Device such as a Biopsy Forcep
• Z-2068-2016 · Apr 6, 2016 · Terminated
  Colonoscope Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, ti