Events

Recall of ORT100 Neurosurgical Table (for Intra-operative MRI Suites)

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-2012-RN-01083-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-10-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01083-1
  • 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 group has recently discovered that when proper procedure is not followed that the foot end of the imris intra-operative or table may be attracted to the mri magnet as the magnet approaches the table. this poses a potential risk of injury to both the patient and operators standing near the table.
  • Action
    Emergo is updating the Instructions for Use (IFU) and MR Conditional Labels on the affected tables.

Device

ORT100 Neurosurgical Table (for Intra-operative MRI Suites)

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia