Events

Safety Alert for Precision 500D and Proteus XR/a with Wireless Digital Radiography Option (Fluoroscopic X-Ray System)

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by GE Healthcare.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2014-02-07
  • Event Date Posted
    2014-02-07
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140207b.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: ge healthcare precision 500d and proteus xr/a with wireless digital radiography option (fluoroscopic x-ray system) the australia therapeutic goods administration (tga) posted a medical device safety alert concerning precision 500d and proteus xr/a with wireless digital radiography option manufactured by ge healthcare. according to the manufacturer, there is an intermittent problem that when a large number of patient examinations are retrieved from the his/ris system, the examinations when displayed on the wdr1 are not properly displayed. if the user continues to attempt to select one of the examinations when this issue has occurred, the system will update the screen and in doing so, potentially select a different examination or patient. if the user does not notice this change and continues to perform the examination, the images will be placed in the incorrect patient file. the manufacturer is providing work around instructions for users to follow when using the wdr1 based systems for examinations. users should pay close attention to the patient examination/entry selected from the worklist prior to selecting the start exam button to ensure the system did not update and select an incorrect examination. the manufacturer is also providing a software upgrade as a permanent fix. for details, please refer to the following link:http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-00121-1 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 07 february 2014.

Device

Precision 500D and Proteus XR/a with Wireless Digital Radiography Option (Fluoroscopic X-Ray System)
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: GE Healthcare Precision 500D and Proteus XR/a with Wireless Digital Radiography Option (Fluoroscopic X-Ray System)
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare