Events

Recall of Ultrasound Upper GI Video Scopes

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Pentax Medical Pte Ltd.

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
    RC-2017-RN-00906-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-08-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00906-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Pentax medical has become aware of an error within the instructions for use for specific models of ultrasound upper gi video scopes.On page 70 the ifu currently reads "the cleaning detergent solution should remain in contact..." and the correct text is "the disinfecting solution must remain in contact..."to date, no incidents have been reported to pentax medical in relation to this error.
  • Action
    Pentax Medical will be providing an updated Instructions For Use (IFU) to affected customers.

Device

Ultrasound Upper GI Video Scopes
  • Model / Serial
    Ultrasound Upper GI Video ScopesModel Numbers: EG-3870UTK and EG-3670URKARTG Number: 234939
  • Manufacturer
    Pentax Medical Pte Ltd

Manufacturer

Pentax Medical Pte Ltd
  • Source
    DHTGA