Events

Safety Alert for 4D Integrated Treatment Console v8.6 with ARIA RT Chart v8.5, all of 4DITC v8.3

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

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
    2011-07-26
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20110726.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
    Field safety notice: 4d integrated treatment console v8.6 with aria rt chart v8.5, all of 4ditc v8.3 medical device manufacturer, varian, has issued an urgent field safety notice to the customers of 4ditc v8.6 with aria rt chart v8.5, all of 4ditc v8.3. the 4ditc may erratically fail to load the planned wedge without warning or notification when receiving an approved plan from the oncology information system (ois). delivery of a treatment field without the planned and calculated wedge filter could result in an over dosage for that beam and potentially an unintended dose uniformity of the target treatment volume. this errant behavior may occur with the above-affected releases of 4d integrated treatment console, v8.6 or earlier. to avoid the issue, the manufacturer recommended customers to make workflow adjustments in their planning, scheduling, and delivery portions prior to delivering a wedge field treatment. according to the local supplier, hong kong is affected. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

4D Integrated Treatment Console v8.6 with ARIA RT Chart v8.5, all of 4DITC v8.3
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: [26 Jul 2011] 4D Integrated Treatment Console v8.6 with ARIA RT Chart v8.5, all of 4DITC v8.3
  • Manufacturer
    Varian

Manufacturer

Varian