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PENTAX EB-1970TKRecalls & reported problems

Hoya Corporation · PENTAX VIDEO BRONCHOSCOPE EB-1970TK · Class 2

All models of PENTAX (72)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04961333227198), received between Mar 29, 2023 and Mar 29, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K131028); 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

Device problems

  • Loose or Intermittent Connection1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 29, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

    THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. BIOPSY INLET PIECE LOOSENED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16633957 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131028. One submission often covers many models, so check the product and lot details in each record.

  • Z-2875-2016 · May 31, 2016 · Terminated
    Pentax Video Bronchoscope Designed to be used with a Pentax Video Processor (including light source), documentation equipment, video monitor, endo-therapy accessories (such as bio
  • Z-2076-2016 · Apr 6, 2016 · Terminated
    Ultrasound Bronchoscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Pulmonary Tract including but not restricted to org
  • Z-2065-2016 · Apr 6, 2016 · Terminated
    Bronchoscope Intended to provide optical visualization of and therapeutic access to the Airway and Bronchial Tree. This anatomy includes, but is not restricted to, the organs, tiss
  • Z-2325-2017 · Jan 11, 2011 · Terminated
    Video Cytoscopes
  • Z-2324-2017 · Jan 11, 2011 · Terminated
    Video Bronchoscope
  • Z-2326-2017 · Jan 11, 2011 · Terminated
    Video Naso pharyngo Laryngoscopes

Other BRONCHOSCOPE (FLEXIBLE OR RIGID) devices

All BRONCHOSCOPE (FLEXIBLE OR RIGID) devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page