Events

Safety Alert for 4d integrated treatment console versions 8.1.3 to 8.8

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
    2012-04-18
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120418b.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) versions 8.1.3 to 8.8 medical device manufacturer, varian medical systems, has issued an urgent field safety notice concerning 4d integrated treatment console (4ditc) v8.1.3 to 8.8. varian has identified that after a plan with wedge field has been opened in 4d integrated treatment console, users may not notice that the wedge filter may actually be missing from a selected field, and the treatment application will not notify the user of this anomaly and will not prevent beam delivery. the user may come to understand that the wedge filter is missing only after the treatment field has been partially or completely delivered and when the user attempts to close the patient from the treatment application. with this situation the treatment application forces the user to unload the patient, requires user authorization, and informs the user that the treatment record for the missing wedge field will not be saved to the ois. varian supplemented that 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. varian is now notifying all affected customers and providing instructions regarding the use of wedges and secondary channel integrity check (scic) which is a data integrity check to further ensure safety of the radiation beam delivery. in addition, varian will provide a software upgrade to all affected users to correct the problems mentioned above. according to the local supplier, the affected devices have 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 versions 8.1.3 to 8.8
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: 4D Integrated Treatment Console (4DITC) versions 8.1.3 to 8.8
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems