Events

Safety Alert for Pentax Bronchoscope and Cystoscope

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Hoya Corporation Pentax Miyagi Factory || Hoya Corporation.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    I1710-520
  • Event Number
    2008DM-0002532 ; 2015DM-0013985 ; 2015DM-0013994
  • Date
    2017-10-31
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=65
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Extra notes in the data

Device

Pentax Bronchoscope and Cystoscope
  • Model / Serial
    EB-1170K, EB-1570, EB-1570AK, EB-1570K, EB-1970, EB-1970AK,
  • Product Description
    These instruments are intended to provide an ultrasonic and optical visualization of the pulmonary tracts (through a video monitor), for therapeutic access of the pulmonary tract. Which includes (without limitation) organs, tissues and subsystems, in addition to the trachea and bronchial tree beyond the stem. Endoscopy for visualization of organs and body cavities of the lower respiratory system.
  • Manufacturer
    Hoya Corporation Pentax Miyagi Factory || Hoya Corporation

Manufacturer

Hoya Corporation Pentax Miyagi Factory || Hoya Corporation
  • Manufacturer Parent Company (2017)
    HOYA Corp.
  • Source
    NIDFSINVIMA