Events

Recall of Discovery XR656 Wall Stand System (X-ray 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-2014-RN-00834-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-07-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00834-1
  • 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 recently become aware of two flashpad detector falls due to a broken nylon support hook. a detector fall could result in an injury to a patient or operator. there have been reported incidents of detector falls, but no injuries have been reported.
  • Action
    Users are advised that if they observe either one of the nylon support hooks as broken or loose on the Discovery XR656 wall stand system, immediately stop use and contact their local GE Healthcare Service Representative. If the hooks are not broken, users may continue to use the wall stand system. GE Healthcare is correcting all affected systems by replacing the nylon hooks. This action has been closed-out on 03/06/2016. This action has been closed-out on 03/06/2016.

Device

Discovery XR656 Wall Stand System (X-ray system)
  • Model / Serial
    Discovery XR656 Wall Stand System (X-ray system)Part Numbers: 5374989 and 5397837Serial numbers: 00000100365HL6, 00000099847HL6, 00000109154HL5, 00000108716HL2, 00000109561HL1, 00000109564HL5ARTG Number: 167617
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd