Events

Recall of Processor HDTV Visera Elite, Processor HDTV Exera III, 3d Visualization Unit, Light Source Xenon Visera Elite, Light Source Xenon Exera III, High Flow Co2 Insufflator, Scopeguide Unit & Video System Center (components or parts of endoscopes)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Olympus Australia Pty 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-2014-RN-00859-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-08-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00859-1
  • 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
    The power switch of the abovementioned models may become stuck after extended use and the following may occur: 1) when the power switch is stuck whilst the unit is ‘on’, the unit cannot be turned ‘off’ using the power switch on the model. 2) when the power switch is stuck whilst the unit is ‘off’, the unit cannot be turned ‘on’ using the power switch on the unit. this issue could result in a delay of diagnosis or treatment procedure as the device would no longer be operational a replacement device would be needed to complete treatment or diagnosis.
  • Action
    An Olympus Field Service Technician will replace the power switch on all the affected units. This action has been closed-out on 18/07/2016.

Device

Processor HDTV Visera Elite, Processor HDTV Exera III, 3d Visualization Unit, Light Source Xenon ...
  • Model / Serial
    Processor HDTV Visera Elite, Processor HDTV Exera III, 3d Visualization Unit, Light Source Xenon Visera Elite, Light Source Xenon Exera III, High Flow Co2 Insufflator, Scopeguide Unit & Video System Center (components or parts of endoscopes)Model Numbers: OTV-S190, CV-190, 3DV-190, CLV-S190, CLV-190, UHI-4, UPD-3 & CV-170ARTG Numbers: 120819, 120820, 194240, 211802, 219880 & 216644
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd