Events

Safety Alert for 4D Integrated Treatment Console (4DITC), version 8.1 SP2 to 10.1 SP1

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

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
    2011-08-18
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20110819.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 (4ditc), version 8.1 sp2 to 10.1 sp1 medical device manufacturer, varian medical systems, has issued an urgent field safety notice concerning 4d integrated treatment console (4ditc), version 8.1 sp2 to 10.1 sp1. 4d itc is designed to assist in providing radiation treatment for patients. there are circumstances in which the 4ditc may be involved in a failure to correctly record treatment history information. the majority of the issues experienced fall into one of three general categories: communication issues between the clinac sub-systems and the 4ditc. communication issues between the 4ditc and the oncology information system (ois). unplanned shut down of the 4ditc or the clinac during treatment. according to the manufacturer, the root cause is related to software design deficiency. varian has scheduled for a mandatory upgrade of the 4ditc to version 10.2 in order to address the above issues. varian also supplemented that the device has been distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

4D Integrated Treatment Console (4DITC), version 8.1 SP2 to 10.1 SP1
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: [18 Aug 2011] 4D Integrated Treatment Console (4DITC), version 8.1 SP2 to 10.1 SP1
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems