Events

Recall of Advantx Legacy/Legacy-D Radiographic and Fluoroscopic System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by GE Healthcare 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-2017-RN-00198-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-02-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00198-1
  • 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
    There have been reported incidents of a patient step detaching from the table. a fall from a patient step detaching while in use could result in an injury to a patient or operator. there have been no injuries reported as a result of this issue.
  • Action
    GE Healthcare will correct all affected products and a GE Healthcare representative will contact affected customers to arrange for the correction. In the interim, customers are advised to check the table tub bottom pan and patient step hardware for any looseness. Discontinue use of the patient step in case of any looseness and immediately contact the GE service representative. This action has been closed-out on 1/03/2018.

Device

Advantx Legacy/Legacy-D Radiographic and Fluoroscopic System

Manufacturer

GE Healthcare Australia Pty Ltd