Events

Recall of Precision 500D and Proteus XR/a with Wireless Digital Radiography Option (WDR1) (fluoroscopic 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-00121-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-02-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00121-1
  • 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
    Intermittently when a large number of patient exams are retrieved from the his/ris system, the exams when displayed on the wdr1 are not properly displayed. if the user continues to attempt to select one of the exams when this issue has occurred, the system will update the screen and in doing so, potentially select a different exam or patient. if the user does not notice this change and continues to perform the exam, the images will be placed in the incorrect patient file.
  • Action
    GE Healthcare are providing work around instructions for users to follow when using the WDR1 based systems for exams. Users should pay close attention to the patient exam/entry selected from the worklist prior to selecting the Start Exam button to ensure the system did not update and select an incorrect exam. GE is providing a software upgrade as a permanent fix.

Device

Precision 500D and Proteus XR/a with Wireless Digital Radiography Option (WDR1) (fluoroscopic x-r...

Manufacturer

GE Healthcare Australia Pty Ltd