Events

Safety Alert for C-Series Clinac® or Trilogy, versions 7.x and 8.x

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
    2011-11-25
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111124.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: varian c-series clinac® or trilogy, versions 7.X and 8.X medical device manufacturer, varian, has issued an urgent field safety notice concerning c-series clinac or trilogy accelerator, versions 7.X and 8.X. an event has been reported to varian involving a c-series clinac® accelerator. the event entails excessive connector resistance, which caused the actual jaw positions to differ from the intended jaw positions without warning the operator. normal daily quality assurance testing and light field verification detected the discrepancy. varian has not received any report of misadministration as a result of the discrepancy. investigation found that a similar issue could arise on the gantry or couch axes. this does not affect the mlc. according to the local supplier, the affected device has been distributed in hong kong. varian has notified all possibly affected customers in hong kong and is continuing to evaluate possible technical solution for this issue. if you are in possession of the affected products, please contact your supplier for necessary actions.

Device

C-Series Clinac® or Trilogy, versions 7.x and 8.x
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Varian C-Series Clinac or Trilogy, versions 7.x and 8.x
  • Manufacturer
    Varian

Manufacturer

Varian