Events

Recall of All Precision 500D Radiographic and Fluoroscopic (R&F;) Systems and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic (R&F;) 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-00573-1
  • 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-00573-1
  • 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 spot film device (sfd)/ intelligent digital device (idd) safety mechanism installed on the above systems may not engage properly at the lower range of sfd/idd travel. this mechanism is installed to hold and prevent the sfd/idd from falling due to a counterweight cable failure. the lower range of travel is 1.1” (28mm) from the lowest point of normal sfd/idd vertical compression. a fall of the sfd/idd could result in an injury to a patient or operator. there have been no reported injuries as a result of this issue.
  • Action
    GE Healthcare will correct all affected products. A GE Healthcare representative will contact you to arrange for the correction. The system can continue to be used provided end users: - Perform preventative maintenance in accordance with your product labeling. This includes inspection of the counterweight cables and pulleys every 6 month, and replacement of the counterweight cables every four years. - Set the manual Myelographic stop on the fluoroscopy carriage during exams. This action has been closed-out on 05/08/2016.

Device

All Precision 500D Radiographic and Fluoroscopic (R&F;) Systems and Advantx Legacy/Legacy-D Radio...
  • Model / Serial
    All Precision 500D Radiographic and Fluoroscopic (R&F;) Systems and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic (R&F;) SystemsARTG Number: 99423
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd