Events

Recall of Tegris OR Table Control (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-2014-RN-00917-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-08-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00917-1
  • 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
    Maquet has identified a potential issue that might occur with the tegris software module for operating room (or) table integration. the fault is only relevant for customers with a license for the or table control 1703.35a0 module and use it to integrate the magnus operating table system.The button commands for "lower leg up" and "leg down" have been switched in the software for the integration of the magnus operating table system. as a result, when these functions are activated on the tegris touchscreen, the wrong movement is executed. thus far, no incidence has been reported in which a person has been injured or endangered.
  • Action
    Maquet Australia is advising the customers to discontinue using the Tegris OR Table Control in conjunction with MAGNUS that is equipped with a software version up to 2.1.x.x,. The problem has been resolved as of version 2.2.x.x. A Maquet Service Technician will provide a software update to resolve this issue. This action has been closed-out on 18/03/2016.

Device

Tegris OR Table Control (Operating room device management system)
  • Model / Serial
    Tegris OR Table Control (Operating room device management system)Part number: 1703.35A0All software versions up to 2.1.x.x are affectedARTG Number: 185134
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

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