Events

Recall of IMRIS Operating Room table (ORT300)

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-2014-RN-01078-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-10-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01078-1
  • 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
    Emergo australia is replacing the table alignment block pins, which are currently made from ferrous materials, with pins made from non-ferrous material due to an incident at a health care facility in the united states. one of the three pins that is used to hold the ort200 table alignment block in place on the floor of the mr suite went missing and was not accounted for by or personnel. during testing the missing pin was pulled into the magnet, damaging the image quality phantom and headrest extension. no injury or death occurred as a result of this incident.
  • Action
    Emergo Australia is replacing the table alignment block pins, which are currently made from ferrous materials, with pins made from non-ferrous material. A field engineer will be sent to the customer site to replace the pins. This action has been closed-out on 06/06/2016.

Device

IMRIS Operating Room table (ORT300)

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia