Events

Safety Alert for Clinac®, Trilogy®, Trilogy Tx™ and Novalis Tx™ Accelerators

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
    2011-09-15
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20110915.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
    Urgent field safety notice: clinac®, trilogy®, trilogy tx™ and novalis tx™ accelerators medical device manufacturer, varian medical systems, has issued an urgent field safety notice concerning clinac®, trilogy®, trilogy tx™ and novalis tx™ accelerators, due to the potential for gantry collisions during remote motion, which may result in patient injury. varian is sending a notification letter to remind users of varian products to take adequate precautions and exercise due care in all aspects of gantry motions, particularly remote motions. failure to follow the instructions in varian’s user documentation, warnings and other product labeling may increase the risk of a collision between the accelerator gantry and the patient, couch, or nearby equipment or personnel. according to the supplier, the affected devices have been distributed hk. if you are in possession of the affected product, please contact your supplier in case of doubt.

Device

Clinac®, Trilogy®, Trilogy Tx™ and Novalis Tx™ Accelerators
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Clinac®, Trilogy®, Trilogy Tx™ and Novalis Tx™ Accelerators
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems