Events

Safety Alert for Clinac, Trilogy, Novalis Tx and Unique jaw carriers

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
    2012-08-20
  • Event Date Posted
    2012-08-20
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120820a.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: varian clinac, trilogy, novalis tx and unique jaw carriers medical device manufacturer, varian medical systems, has issued a field safety notice concerning clinac, trilogy, novalis tx and unique jaw carriers. according to varian, an anomaly has been identified with the clinac, trilogy, novalis tx and unique jaw carriers. the jaw carriers function to couple the x-jaws to their respective drive screw mechanisms used for controlling field size. some jaw carriers were manufactured with the incorrect metal alloy, which can potentially cause the jaw carrier to crack. if both jaw carriers on the same x-jaw were to crack, the jaw would be able to move freely in the closed direction. in this case, the deviation of the jaw position will not be detected by the position readout interlock circuitry. treatment after such a failure occurs may lead to an underdose of the intended target volume. this condition was found on some machines. no patient mistreatments were reported to varian medical systems. according to the local supplier, the affected devices have been distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 20 august 2012.

Device

Clinac, Trilogy, Novalis Tx and Unique jaw carriers
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Varian Clinac, Trilogy, Novalis Tx and Unique jaw carriers
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems