Events

Recall of PENTAX COLONOSCOPES

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

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
    20024
  • Event Risk Class
    II
  • Event Initiated Date
    2001-08-15
  • 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
    There is an increased potential that these endoscopes may experience a loss of the angulation control. the angle wire connecting receptacle was changed from machine brass to zinc mold.

Device

PENTAX COLONOSCOPES
  • Model / Serial
    Model Catalog: (Lot serial: 2001 and/or repaired after); Model Catalog: (Lot serial: July 1 2000.); Model Catalog: (Lot serial: all units mfr after june 1)
  • Product Description
    COLONOSCOPE
  • Manufacturer
    PENTAX PRECISION INST CORP

Manufacturer

PENTAX PRECISION INST CORP
  • Manufacturer Address
    ORANGEBURG
  • Source
    HC