Events

Recall of IMRIS ORT100 and ORT300 Operating Room Tables

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

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-2018-RN-00208-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-03-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00208-1
  • 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 ort100 and ort300 tables may drift while in use, which could potentially result in unintended movement of the table. the drift occurs slowly over time and typically is not recognised until after several hours. there have been two reports of injury overseas as a result of this issue.
  • Action
    Emergo is advising that the following corrective actions will be undertaken: · ORT100: The tables will be tested for drift symptoms. No further action will occur for tables that pass the drift test. For tables that do no pass the drift test, a hydraulic fluid flush and filter change will be performed. · ORT300: All customer sites with these tables shall have the hydraulic fluid flushed and exchanged for new and the filter element will be changed. A drift test will also be performed.

Device

IMRIS ORT100 and ORT300 Operating Room Tables
  • Model / Serial
    IMRIS ORT100 and ORT300 Operating Room TablesPart Numbers: 110470-000 and 114093-000Serial Numbers: 10003241 and 10002255ARTG Number: 276861Emergo Asia Pacific T/a Emergo Australia - Table, x-ray system, diagnostic, general-purpose, powered
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia