Events

Recall of PENTAX VB-2000 VIDEO BRONCHOSCOPE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PENTAX CORPORATION.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    19897
  • Event Risk Class
    II
  • Event Initiated Date
    2002-03-28
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Change made as a preventive action to reduce potential for a costly repair should a failure occur.Action prompted when a hole was worn into distal body of a scope.Lubricant leaked out but poses no health risk.

Device

PENTAX VB-2000 VIDEO BRONCHOSCOPE
  • Model / Serial
    Model Catalog: (Lot serial: all)
  • Product Description
    model EB-1530T3
  • Manufacturer
    PENTAX CORPORATION

Manufacturer

PENTAX CORPORATION
  • Manufacturer Address
    TOKYO
  • Source
    HC