Events

Recall of Secondary 19" Touchscreen - TEGRIS System (Operating room device management system)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Maquet 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-2013-RN-00851-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-08-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00851-1
  • 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
    A tegris system that has a second touch monitor used to operate the operating room (or) table, is not equipped with an emergency stop button. in an unlikely event of malfunction of the table control module, which could lead to unexpected movement of the or table, this secondary touch monitor could not be used to stop the table in an emergency situation. thus, the intended immediate stop of the table movement could be delayed.
  • Action
    Maquet is providing instructions to the user to disconnect both the primary and secondary touch screens from the OR table. The table can still be controlled by the corded or infrared hand control. A second emergency stop button will be installed on all existing and future secondary touch screens, which will be available in Australia in October 2013.

Device

Secondary 19" Touchscreen - TEGRIS System (Operating room device management system)
  • Model / Serial
    Secondary 19" Touchscreen - TEGRIS System (Operating room device management system)Part number: 1707.05A0ARTG number: 185134
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    DHTGA