Events

Recall of Single and dual LCD monitor suspensions used on Precision RXi fluoroscopic imaging systems

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-2015-RN-00575-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-06-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00575-1
  • 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
    Ge healthcare has become aware of a reported incident where a monitor fell from the suspension. a fall of a monitor could result in an injury to a patient or operator. there have been no injuries reported as a result of this issue.
  • Action
    A GE Healthcare representative will contact affected customers to arrange for the correction. In the interim, users are advised to perform a visual check before and after each use for the presence of the four (4) mounting screws. Check the secureness of these screws by hand. If these screws are present and secure, users may continue use of the system. If any of these screws are missing or can easily be turned by hand, follow the precautions below before continuing use with the monitor(s). - Position the monitor suspension in the most frequently used position and limit further movement as much as possible. - Clearly inform (e.g. through signage and verbal instructions) the users and other auxiliary personnel who may come in contact with the system to not move the monitor suspension once in position. - Contact the GE Healthcare representative to inform them of any loose or missing screws. This action has been closed-out on 17/08/2016.

Device

Single and dual LCD monitor suspensions used on Precision RXi fluoroscopic imaging systems
  • Model / Serial
    Single and dual LCD monitor suspensions used on Precision RXi fluoroscopic imaging systemsARTG Number: 99423
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd