Events

Recall of ULTRA-SOUND SCOPE

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
    16449
  • Event Risk Class
    II
  • Event Initiated Date
    2014-06-23
  • 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
    Pentax medical has been notified of a potential risk related to the use of certain models of ultrasound gastroscope listed above in combination with aspiration needles if the instructions for use document is not followed carefully by the user. specifically if the user fails to properly position the elevator while advancing the aspiration needles through the endoscope then the needle can derail from the elevator. this could result in the needles not being visible in the endoscopic or sonographic field of view leaving to the possibility of patient injury such as perforation.

Device

ULTRA-SOUND SCOPE
  • Model / Serial
    Model Catalog: EG-3870UTK (Lot serial: A110260); Model Catalog: FG-36UX (Lot serial: E110164); Model Catalog: EG-3630U (Lot serial: E110164); Model Catalog: EG-3830UT (Lot serial: E110164); Model Catalog: EG-3870UTK (Lot serial: E110164); Model Catalog: FG-36UX (Lot serial: A110308); Model Catalog: EG-3630U (Lot serial: A110308); Model Catalog: EG-3830UT (Lot serial: A110308); Model Catalog: EG-3870UTK (Lot serial: A110308); Model Catalog: FG-36UX (Lot serial: E110332); Model Catalog: EG-3630U (Lot serial: E110332); Model Catalog: EG-3830UT (Lot serial: E110332); Model Catalog: EG-3870UTK (Lot serial: E110332); Model Catalog: FG-36UX (Lot serial: A110247); Model Catalog: EG-3630U (Lot serial: A110247); Model Catalog: EG-3830UT (Lot serial: A110247); Model Catalog: EG-3870UTK (Lot serial: A110247); Model Catalog: FG-36UX (Lot serial: A110468); Model Catalog: EG-3630U (Lot serial: A110468); Model Catalog: EG-3830UT (Lot serial: A110468); Model Catalog: EG-3870UTK (Lot serial: A110468); Model Catalog: FG-36UX (
  • Product Description
    ULTRASOUND GASTROSCOPES
  • Manufacturer
    PENTAX CANADA INC.

Manufacturer

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