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-00209-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-03-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00209-1
  • 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 imris ort100 and ort300 table rotational locking mechanism may experience a failure. the ort100 rotational locking mechanism can become disengaged or unlocked while in use, which could potentially result in unintended movement of the table due to the older lock design. the ort300 rotational lock may fail to operate such that it cannot change states between locked and unlocked as a result of actuator failure due to improper adjustment of the actuator or the linkage. there have been no reports of injury as a result of this issue.
  • Action
    Emergo is advising: - for users with ORT 100 tables: the rotational locking mechanism in all affected ORT 100 tables will be replaced with the most current design; - for users with ORT 300 tables: all customer sites with these tables shall have the rotational lock operation verified and adjusted, if necessary.

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, 10002255ARTG Number: 276861(Emergo Asia Pacific - 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