Events

Recall of PENTAX DUODENOSCOPE

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

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
    15233
  • Event Risk Class
    II
  • Event Initiated Date
    2018-02-08
  • 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
    In march 2017 as part of field action 2017-001-c pentax medical informed customers about a potential cracks and gaps in the distal cap of the ed-3490tk and instituted a distal cap inspection program. during discussion with the us fda as part of this field action pentax medical agreed to redesign the ed-3490tk's forceps elevator mechanism o-ring and distal end to reduce the risk of cross-contamination resulting from body fluids entering portions of the ed-3490tk that cannot be easily cleaned.

Device

PENTAX DUODENOSCOPE
  • Model / Serial
    Model Catalog: ED-3490TK (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    PENTAX VIDEO DUODENOSCOPE
  • Manufacturer
    PENTAX CANADA INC.

Manufacturer

PENTAX CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    HOYA Corp.
  • Source
    HC